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SPECIAL NEWS ISSUE: MEDICAL | TECHNICAL | PHARMACEUTICAL | INDUSTRIAL 1 7 - 2 0 N OV E M B E R 2 0 2 5 New technologies, old limitations? Robot-assisted surgery in Europe: high tech between scalpel and legislation dards apply.” Many of these aspects would need to be addressed in both national and European regu- latory frameworks. Conclusion: recognize opportunities, remove obstacles Regardless of the future potential of remote surgery, robot-assisted pro- cedures already offer concrete benefits for patients and healthcare systems—through more precise in- terventions, shorter hospital stays, and potentially fewer complications. Nevertheless, the barriers to wide- spread adoption remain high. In many European countries, high in- vestment and maintenance costs contrast with a lack of financial in- tegration. This is the case despite the existence of initial financing models from manufacturers de- signed facilitate acquisition. Only if these structural and finan- cial hurdles are systematically ad- dressed can robotic surgical sys- tems realize their full potential and play a central role in a sustainable, efficient, and patient-centered healthcare system. ■ to More than just MRI accessories www.allmri.com i d o r a c i d e M © cally feasible, and countries such as China have already gained ex- perience with sur- gery—often with targeted govern- ment specially developed network infrastructure. support remote and In Europe, however, telesurgery re- mains a vision for the future: there are no clear legal frameworks. “There is no unified legal basis that permits or regulates cross-border remote surgery,” says Dr. Wand- höfer. Key issues such as liability, data protection, medical ethics stan- dards, and responsibilities in emerg- ency situations remain unresolved. Cybersecurity also continues to be a source of uncertainty: “You can‘t simply order a stable connection for a surgical procedure from a telecom provider,” Dr. Wandhöfer explains. “There are no clear regu- lations governing connectivity in the operating room—who is liable in the event of a network failure, how backup systems must be or- ganized, or what minimum stan- Advertisement The use of surgical robots offers a wide range of possibilities, but in Europe the technology is often unable to reach its full po- tential. Dr. med. Christoph Wand- höfer from Medicaroid Europe explains why. Robot-assisted surgery is con- sidered one of the most promising developments in modern medicine. It enables precise, minimally invas- ive procedures that can speed up recovery. But its true potential goes far beyond that: technologies such as surgery performed by experienced sur- geons across large distances—are bringing more widespread, special- ized care within reach. telesurgery—remote Despite increasing technological maturity, this vision still faces prac- tical hurdles in Europe. Ethical and regulatory frameworks, approval processes, and national differences are the main barriers to integrating these technologies into routine clinical practice. One example is the hinotori robotic assistance sys- tem from Japan, which illustrates the tension between technological progress and legal certainty in a highly sensitive field. Dr. Christoph Wandhöfer Dr. med. Christoph Wandhöfer is Head of Medical and Clinical Affairs at Medicaroid Europe. The regulatory bottleneck: CE certifi- cation under the MDR Before such systems can be used in Europe, they must obtain CE mark- ing in accordance with the Medical Device Regulation (MDR). In effect since 2017, this regulation is con- sidered one of the world’s most stringent frameworks for medical devices. It categorizes devices by risk level; due to their invasive ap- plication, surgical robots are classi- fied in a high-risk category that requires compre- hensive evidence of technical, clini- cal, and application-specific safety. particularly A key aspect here is the “intended use”—that is, the precise medical application of the product. The manufacturer must specify whether the system is to be used in, gyne- www.healthcare-in-europe.com cology, urology, or general surgery, for example, and must provide tar- geted evidence that the system functions safely within that particu- lar field. Several approaches can be used for this purpose, ranging from cadaver studies and clinical trials to comparisons with inter- nationally established systems. practice, however, In im- plementation is often challenging. “The current EU MDR from 2017 is a document of over 170 pages, in- cluding numerous annexes that sets out the requirements for all medical devices. Nonetheless, there are always unresolved ques- tions when it comes to the details,” explains Dr. Wandhöfer. is responsible One reason for this lack of clarity is that the process begins with the selection of a “notified body”—an independent certification organiz- ation such as TÜV Nord or TÜV Süd—which for evaluating and certifying the prod- uct. The number of notified bodies was significantly reduced after the previous regulatory directive, the MDD, was repealed and replaced by the EU MDR. Those that remain must realign themselves and adapt to increased requirements for technical docu- mentation. significantly the “As a result, the certification pro- cess tends to proceed in cycles: documents are submitted, ques- tions are raised, and adjustments and corrections are made until the notified body‘s requirements are finally fulfilled,” says Dr. Wand- höfer. In addition, many products that were already approved under the previous directive must now undergo recertification. All of this leads to bottlenecks and, in some cases, lengthy waiting periods. It is difficult to predict how long the process will take—it could be six months or a year and a half. In Germany, When innovation has no reimbursement code Another obstacle to widespread clinical use is a lack of financial in- tegration. robot- assisted procedures cannot cur- rently be reimbursed, regardless of the added value for patients or the cost incurred by hospitals. This is offset by high investment, organiz- ational, and training costs. for modern Countries like Poland have already introduced initial reimbursement models to provide targeted incen- tives technologies. These models could also serve as a reference for other countries—es- pecially if robotic procedures are expected to help reduce com- plications and shorten hospital stays in the long term. “What is needed are harmonized regulations across national borders,” says Dr. Wandhöfer. Remote surgery: regulatory pitfalls This patchwork of organizational, legal, and ethical frameworks also complicates the implementation of one of the most exciting and media-effective potentials of sur- gical robotics: remote surgery. The idea of making medical ex- cellence available regardless of lo- cation is as old as robotics itself. The U.S. military, in particular, in- vested in the development of surgi- cal capabilities for battlefield con- ditions decades ago—thus laying the foundation for robotic surgery. Today, with the rollout of 5G and the prospect of 6G, much is techni-
2 EH @ MEDICA Sponsored • Spotlight Estonia Smart HealthTech Built on Digital Trust infection-control Europe’s healthcare systems face growing pressure: fewer staff, higher de- mands, and increased docu- mentation. Estonia is already built for this. With 99% of health data digital, digital trust is built into everyday healthcare – giving Estonian companies a strong foundation for efficient collabor- ation, fast traceability, and AI- supported operations. “Quality and reliable delivery are essential in Germany, and Estonian companies deliver. That’s why in- ternational partners return to them at MEDICA year after year,” says Leana Kammertöns, Export Ad- viser Germany at Enterprise Esto- nia – the government agency ad- vancing international business partnerships. This expertise translates into a di- verse HealthTech sector: from digi- tal care solutions to clinical safety products and precision manu- facturing. Smart Care Delivery: Digital & AI-Enabled Solutions Responding to the workforce crisis and the push for digitalization, Es- tonian Rehasoft’s cloud-based home-care solution CloudCare sup- ports municipalities and care pro- viders by AI-automated planning, routing, and last-minute schedule changes – so carers can spend more time with people, not paper- work. “Soon, one-third of Europe’s citizens will be over 60. AI is essen- tial because we simply cannot re- cruit enough care professionals to meet demand,“ says Kari Mari- puu, CEO of Rehasoft. “By combin- ing practical experience from so- cial services with AI-based planning, we help deliver timely support and let elderly people live longer, fuller lives at home.” Reliable Clinical Safety From intensive care to operating theatres, respiratory protection is critical for patient safety and staff wellbeing. With over 30 years of experience and a worldwide dis- tribution network, Pharma Sys- tems offers advanced respiratory care products that reduce risks for clinical teams. “Our filtration solutions are a cru- cial barrier, protecting both the pa- tient and the medical equipment safety, and full traceability. Their vacuum tubes are made from PET material to ensure vacuum integrity and prevent sample contamination. Infection Control Where It Matters Most Infection control remains a corner- stone of safe healthcare, especially in overburdened systems. Precision That Keeps Healthcare Moving Underpinning these healthcare sol- utions is a foundation of precision engineering. At the heart of every great medical device is a com- ponent manufactured with ab- solute precision. CNC Star special- izes in high-precision components for endoscopy: small to medium ing as an extension of their own team,” explains Martin Voolpriit, Quality Systems Manager at TT Print. “Our investments in digitali- sation and a pharma-specific pro- duction park enable us to react quickly to regulatory changes and production peaks across Europe.” from cross-contamination,” says Vahur Leenurm, Production Man- ager at Pharma Systems. “Our product range is certified under the Medical Device Regulation (MDR) and includes combined bac- terial/viral filters as well as heat and moisture exchangers.” The focus on fundamentals is also the driving force behind Inter- VacTechnology, a manufacturer of vacuum blood collection systems. The company’s manufacturing pro- cess, which includes GMP-certified clean rooms, ensures sterility, With over 25 years of experience, Chemi-Pharm exports to more than 20 countries. The company provides a comprehensive range of ISO-certified, Ecolabel-certified, and biodegradable disinfectants, cleaning agents, and skincare prod- ucts. A key focus is their special product line for healthcare in- stitutions, designed to protect the health of medical staff. “We’re committed to continuous in- novation, outstanding customer support, and environmental re- sponsibility. These values have helped us build a strong, reliable distribution network – and we’re ready to grow it further at MEDI- CA,” says Joonas Lahe, Managing Director at Chemi-Pharm. By engineering the surfaces where hygiene matters most, hospitals and healthcare facilities gain a criti- cal defence layer. Using advanced solid-surface composite materials with antibacterial components, Eumar Santehnika equips facil- ities with surfaces that reduce microbial risk, support faster room turnover, and meet the rising de- mands for hygiene. With over 25 years of experience and projects in more than 30 coun- tries, the company’s seamless, non-porous products are engin- eered to comply with clinical stan- dards and ergonomic require- ments. batches, rapid prototypes, and ur- gent orders supported by capabil- ities in reverse engineering and fine-tolerance manufacturing. Visit the Trade Estonia stand at MEDICA 2025 Hall 15 · Stand D24 “Many clients come to us because they’re tired of vendors who just make to spec,” says Kristina Maks, Sales Manager at CNC Star. “We act as a machining partner, proactively solving tolerance issues and adapt- ing to real production needs.” A similar dedication to micro-level detail defines Mikroonik. Since second-generation, 1997, this family-owned has specialized in precision engin- eering, crafting ultra-precise micro- components for the medical and endoscopy industries. company “At the fair, you can see and feel our micro parts up close and dis- cover what true micron-level preci- sion means,” says Tõnis Keel, CEO of Mikroonik. “We are a flexible partner for both prototypes and small series, and invite quality and engineering managers to come talk to us about their next project!” Packaging and documentation re- main essential as well. TT Print is a specialized and pharma-audited printing house serving the phar- maceutical industry across Europe. “In today’s pharma supply chains, clients need a trusted partner act- Networking Reception – Tues- · 16:00 day, 18 November Meet the teams behind Estonia’s HealthTech solutions, exchange ideas, and enjoy drinks and snacks in a relaxed setting. Quiz – Drop by the Estonian stand any time Discover surprising digital health facts at the Estonian stand and win prizes! Learn more about the participating Estonian companies: tradewithestonia.com EH @ MEDICA 2025
EH @ MEDICA 3 Sponsored World’s First Dual IVDR-Certified One-Step Strep A Rapid Test by GenSure Biotech Sets New Benchmark for Rapid Respiratory Infection Diagnostics An innovative Group A Strepto- coccus “One-Step Antigen Extrac- tion + Detection” Kit (immunoch- romatography), developed by GenSure Biotech Inc., has suc- cessfully obtained both Class B and Class C EU IVDR certifi- cations for in vitro diagnostic medical devices. It is the first and only single-step Strep A Rapid Test in the world to receive dual certification both pro- fessional use and self-testing, set- ting a new global standard for next-generation rapid diagnostic technology. for This milestone is not just a com- pliance breakthrough. It marks a new global benchmark in the rapid detection of Group A Streptococ- cus for Chinese companies—with original technology and an inter- national-level quality system, Gen- Sure Biotech Inc. has successfully set a new standard, and showcased the technical and regulatory capa- bilities of China’s IVD industry in the rapid-diagnosis field. respiratory 1. IVDR: “Ceiling” of Diagnostic Industry Regulation & Touch- stone of Technical Capability The EU’s IVDR centres on full-life- cycle regulation and clinical evi- dence, creating a robust safety-and- efficacy shield for IVD products. Many traditional rapid-test prod- ucts have faced elimination due to inability to meet its stringent per- formance validation and clinical requirements. traceability a into cedure single-step operation while maintaining ac- curacy comparable to central lab- oratory reference methods. This in- novation solves the challenge of balancing simplicity and preci- sion, enhancing efficiency in clini- cal and home settings. 2. Precision Diagnostics: Ad- dressing the Global Burden of GAS Group A Streptococcus (GAS) in- fection remains a major public health concern globally. According to The Lancet, there are over 600 million cases of GAS pharyngitis and 110 million cases of skin in- fections each year. In Europe, GAS infections are prevalent among children, with 20–30% of acute pharyngitis caused by GAS. In- vasive GAS infections (iGAS) have high mortality, with EU data repor- ting 10–25% fatality rates. GenSure Group A Streptococcus Rapid Test Kit is the first and only one-step antigen extraction + detection product worldwide to obtain IVDR certification. Its breakthrough lies in the propri- etary 2-in-1 reaction buffer sys- tem, which simplifies the pro- Rapid and accurate diagnostics are critical for rational medication use, controlling infection, and reducing complications. This innovative kit provides instant and reliable test- ing for clinics, pharmacies, and home use, reducing the “testing-to- treatment” window from 24–48 full-lifecycle quality management to win future markets. 4. Core Advantages: Simple, Ac- curate, Reliable e r u S n e G © The kit emphasizes “simplicity, ac- curacy, and reliability”, optimiz- ing the workflow for professional and home settings. Key features in- clude: GenSure Strep A Rapid Test fea- tures a unique 2-in-1 buffer system with a preloaded antigen extrac- tion buffer, streamlining sample processing to just 2 minutes. By combining two traditional buffers into one and eliminating stepwise reagent addition, it reduces oper- ational errors, shortens processing time, and ensures accurate re- sults—even for non-professional users. 5-Minute Rapid Readout While most competitor products require 10–15 minutes, GenSure’s product delivers inter- pretation as fast as in just 5 min- utes—accelerating clinical decision making and home-check experi- ence. clear 24-Month Extended Shelf Life: Stable storage under 4–30 °C, out- performing most similar products (typically 12–18 months), reducing inventory pressure and resource waste. Dual Use for Professional and Self-Test: Suitable for both adults and children, serving diverse scen- arios from emergency, pediatrics to home self-testing. 5. Future Prospects: Advancing Global Public Health Through Diagnostic Innovation “IVDR certification means a com- prehensive validation of our scien- hours to just a few minutes. 3. Redefining Market Landscape: From “Regulatory Access” to “Value Leadership” IVDR certification Achieving means that GenSure one-step antigen extraction + detection kit holds the “passport” for un- obstructed access to the EU mar- ket. More importantly, it is reshap- ing industry competition logic and market structure: For medical institutions, IVDR cer- tification is the most authoritative endorsement of product perform- ance and quality. In procurement decisions it is no longer merely a gateway but a core criterion for as- sessing clinical value and reliabil- ity, helping institutions quickly identify top solutions. For industry competition, this cer- tificate sets a new technological benchmark. It signals a shift in IVD rapid-test competition from “price- driven” / “function-driven” to a higher dimension of “evidence- driven” / “value-creation” com- petition. Companies must provide clinical evidence verified to inter- national standards and implement Biotech GenSure tific team, R&D and quality systems,” said Dr. Terry Chan, CEO of Inc. “Our goal is not just market access, but solving real clinical challenges and providing better solutions for global respiratory-infection preven- tion and control.” The company will continue to ad- vance global registration and appli- cation of this product in more mar- kets, delivering a diagnostic solution that meets the highest glo- bal standards. 6. Expanding the IVDR Portfolio: Accelerating Global Access to Trusted Diagnostics In addition to the Strep A Rapid Test, three other GenSure Bio- tech products — the Flu A+B Rapid Test, HCG Pregnancy Rapid Test, and LH Ovulation Rapid Test — were also success- fully IVDR-certified in August 2025. Furthermore, five ad- ditional products, including the COVID-19 Rapid Test, COVID- 19/Flu A+B Test, COVID-19/RSV/Flu A+B Combo Test, Fecal Occult Blood (FOB) Rapid Test, and H. pylori Antigen Rapid Test, are expected to join the portfolio soon, strengthening GenSure’s commitment to global quality stan- dards and clinical excellence. IVDR-certified Combo With continuous innovation and stringent regulatory compliance, GenSure Biotech Inc. is em- powering healthcare professionals and patients worldwide with faster, more accurate, and more access- ible diagnostic solutions. For partnership or product in- quiries, please contact info@gens bio.com call +86–10–56370138. or Sponsored Medical-Grade Wet Wipes for Hospitals and Patient Care C H A © AHC manufactures medical wipes that meet the strict hygiene needs of hospitals, clinics, laboratories and long-term care. Production takes place in ISO-certified class 100K cleanrooms with EDI- purified water and controlled for- mulation systems. We support pri- vate label and OEM customers with disinfecting wipes, patient care wipes, skin-friendly formulas, ultrasound wipes and antibacterial solutions. Reliable quality and flexible customization help global partners meet medical standards with confidence. EH @ MEDICA 2025
4 EH @ MEDICA Sponsored • Light therapy Bioptron Hyperlight Therapy: Revolutionizing Non-Invasive Healing to support the body‘s natural healing processes. polychromatic, light, Bioptron Hyperlight Therapy de- vices represent a pinnacle of photobiomodulation technology, offering a versatile, user-friendly, and clinically proven approach to health and well-being. Distin- guished by its patented form of po- non- larized, coherent is designed for a broad spectrum of users, from lay individuals seeking home-based solutions to health- care professionals in clinical set- tings. With over 35 years of experi- ence in worldwide market, and a vast portfolio of clinical trials and peer-reviewed publications, Biop- tron has a long-standing record of positive clinical impact, validated therapy this light. The polychromatic, Bioptron Hyperlight Therapy is a certified medical device that uses a patented form of polar- ized, non- coherent therapy works by delivering specific characteristics, which light stimulate local blood micro- circulation, enhance cellular re- generative process, decrease pain and stimulate immune sys- tem. This non-invasive and pain- less photobiomodulation method is clinically proven to accelerate wound healing (chronic and acute), relieve pain (including chronic and acute pain), and treat a variety of dermatological conditions. It is designed to be used by both healthcare pro- fessionals and patients at home, offering a safe and effective way © Zepter Group by its medical certification in the European Union for a compre- hensive list of indications. The true strength of Bioptron ther- apy lies in its versatility and its ability to address multiple medical indications through a single, non- invasive technology. It is medically certified for wound care, pain man- agement, the treatment of dermato- logical disorders, and Seasonal Af- fective Disorder (SAD). The device is medically certified for use on newborns, children, and adults. In wound care, Bioptron‘s effec- tiveness is particularly notable. When used as an adjunct to stan- dard wound treatment protocols, the therapy can accelerate the clo- sure of both chronic and acute wounds by approximately 50%. The hyperpolarized light works by stimulating local blood circulation, promoting cellular regeneration, and reducing inflammation, which are all critical factors for efficient healing. This mechanism helps to create an optimal environment for the body‘s natural regenerative processes, allowing for faster and more complete wound closure, avoiding dehiscence. For pain management, Bioptron offers significant relief, particularly for chronic conditions like arthritis or persistent back pain, in rehabili- tation and physiotherapy, as well as sports medicine. The therapy‘s ability to decrease inflammation and improve local blood flow is key to its efficacy. Studies have shown that the use of Bioptron in patients with severe osteoarthritis, can improve the mobility of the af- fected joint by an average of 17% while decreasing pain levels by 25%. In physiotherapy, Bioptron Hyperlight Therapy is the adjuvant therapy which enhances the results of rehabilitation techniques by around 15%. Perfectly suited for in- tegration with standard physio- therapeutic procedures, it can be a crucial component of compre- hensive rehabilitation programs for common sports ailments such as ankle and knee injuries, tendonitis, and muscle pain The non-invasive nature of the treatment makes it an ideal option for patients seeking a safe, drug-free way to manage their discomfort and regain mobility. When it comes to dermatological issues, Bioptron provides a gentle yet effective solution. The light therapy decreases inflammation and promotes skin regeneration, making it highly effective in ma- naging conditions such as acne, dermatitis and psoriasis. Unlike harsh topical treatments, Bioptron works in a soft, non-aggressive manner, addressing the symptoms while simultaneously regenerating the skin and easing patient discom- fort. Multiple clinical trials have shown that Bioptron decreases skin thickness in cases of psoriasis and dermatitis by up to 47%, and decreases the symptoms of these pathologies by an average of 60%. It helps to restore the skin‘s natural barrier function and provides last- ing relief. Finally, Bioptron‘s benefits extend to mental and emotional well- being. For those suffering from Seasonal Affective Disorder (SAD), the therapy can be a powerful tool. By providing a broad spectrum of light, it helps to regulate circadian rhythms and neurotransmitter le- vels, leading to a significant de- crease in depressive symptoms. The ease of use and the proven clinical outcomes make Bioptron Hyperlight Therapy a pivotal sol- ution in a variety of therapeutic areas. ■ Visit Bioptron at MEDICA 2025 Hall 4 · Stand H25 EH @ MEDICA 2025
EH @ MEDICA 5 Sponsored • For Optimal Patient Care Pocketalk enables the best AI-powered doctor-patient translation solutions Device Management with Pocketalk Ventana For organizations, Pocketalk also offers centralized device manage- ment with the Ventana platform. This management panel helps in- stitutions administer multiple Pocketalk devices and unlock the full potential of smart translators. Pocketalk Ventana operates under strict data protection regulations. By providing valuable insights, the platform enables organizations to make data-driven decisions about their translation strategies. In ad- dition, IT teams can group and manage individual devices, ensur- ing smooth operations and optimal performance. Medical institutions can also export translations with timestamps, streamlining the cre- ation and documentation of patient records – contributing to efficient, high-quality care. The Advantages of AI-Based Translati- ons with Pocketalk at a Glance • Fast, high-quality real-time trans- lations • Flexible and always up to date k l a t e k c o P © Successful Communication in European Healthcare Facilities Healthcare institutions across Eu- rope (and worldwide) rely on Pocketalk to ensure successful pa- tient communication. By using Pocketalk’s excellent translation solutions, they build trust and de- liver more inclusive, empathetic healthcare. with cutting-edge AI technology • Secure and fully compliant with data protection regulations • Proven global technology, ideally suited for healthcare, logistics, education, government, and re- tail Pocketalk Solutions: Effective Communication for Better Treatment Outcomes In today’s globalized and digital- ized world, people from diverse cultural and linguistic backgrounds constantly interact – including in healthcare. To facilitate mutual understanding, Pocketalk provides state-of-the-art tech- nology at the highest level. The company’s mission is to bring people in medical and care facilities, seam- less communication is a crucial prerequisite for successful treat- ment. It optimizes processes and supports staff in times of limited resources – a classic win-win scenario. ■ together. Especially translation municate at the push of a button in hospitals, clinics, and care facil- ities. Doctor-patient communi- cation is enabled in 92 languages – always in compliance with data protection requirements. Pocket- alk’s are powered by Prism Language Sys- tems, the company’s proprietary language engine. translation services language barriers Today, in healthcare can be easily over- come – leading to improved pa- tient care. Pocketalk, a provider of comprehensive translation solutions, delivers accurate, mo- bile, and secure translations that exceed industry security stan- dards. Doctors, nurses, and patients rely on smooth communication. With- out a common language, misunder- standings and misdiagnoses may occur. But what happens when healthcare professionals and pa- tients do not speak the same lan- guage? With Pocketalk’s translation solutions, such barriers can be overcome quickly and reliably. Different Solutions for Different Needs Pocketalk, the global leader in translation hardware, software, and integration, bridges language gaps with portable realtime translators, intuitive web-based tools, or an easy-to-use app. This allows people of diverse backgrounds to com- EH @ MEDICA 2025
6 EH @ MEDICA Launch of new national programme A new “impulse” for equitable lung cancer screening in France Lung cancer accounts for nearly one-fifth of all cancer deaths in the EU, yet unlike breast, colo- rectal, and cervical cancers, no organized screening programme exists to detect the disease be- fore symptoms appear. This Sep- tember, France will attempt to change that with an ambitious pilot programme that could res- hape European lung cancer de- tection. Professor Marie-Pierre Revel presented the details at the French Thoracic Imaging Society Spring Days in Marseille, convey- ing the urgent need for this measure and its immense pre- ventive potential. Detect early, treat only when necessary, and protect the vulner- able from unnecessary stress or harm: This is the essence of IM- PULSION (Implementation of pul- screening by monary scanner the population), France’s pioneering pilot pro- gramme for population-based lung cancer screening, the Head of the Imaging Department at Cochin Hospital in Paris outlined. cancer in A structured approach to early detection The programme will include 20,000 participants aged 50–74, all with a significant smoking history – defined as at least one pack per day for 20 years, either current smokers or those who quit less than two decades ago. The partici- pants will undergo three CT scans over four years: baseline, one-year follow-up, and a final scan after two more years if previous results are normal. Lung cancer screening c i c a r o h T h c n e r F e h t e r e h r w e g u o , R e e l d l n i e a s s i l r é a M M © Marseille, where the French Thoracic Imaging Society Spring Days took place. The new programme builds on the CASCADE study from 2022, ad- dressing key challenges identified. ‘We learned from CASCADE that not every nodule is cancer,’ Revel said. ‘And not every positive scan requires a biopsy or surgery.’ The design prioritizes minimizing over- diagnosis, patient anxiety, and un- necessary interventions while maintaining effective early detec- tion. Expanding training, exploring AI potential One of Impulsion’s most notable innovations lies in its radiologist training model. Drawing from the certification programme of the pre- vious study, endorsed by the Euro- pean Society of Radiology (ESR), the team has developed a rigorous national training pathway for gen- eral radiologists – those outside thoracic specialties – who will read the scans. Artificial intelligence (AI) will also play a central role in the screening process, Revel explained. The first 2,500 cases will undergo double reading by both radiologists and AI. ‘The idea is that AI could become the second reader,’ she explained. ‘If the first radiologist and AI agree, a second human reader may no longer be necessary.’ This “belt and braces” approach aims to help standardize detection while addressing resource limi- tations in a field where highly trained thoracic radiologists re- main scarce. Reaching beyond the usual suspects To recruit participants, the pro- gramme will access occupational health networks at major French employers like Stellantis, Danone and SNCF. This strategy puts a greater emphasis on target popu- lations which are traditionally underrepresented in screening ef- forts. ‘These physicians are trained, motivated, to people who may never set foot in a pneumologist’s office,’ Revel noted. ‘This is true public health outreach, and it costs nothing.’ connected and Beyond its initial focus on lung cancer, the programme will ident- ify coronary artery calcifications visible on low-dose CT scans, po- tentially preventing life-threatening cardiovascular events. Participants will also receive smoking cessation counselling, expanding the pro- gramme‘s preventive impact. ‘We won‘t just save lives by finding cancer,’ the expert said. ‘We will also prevent heart attacks and help people quit smoking.’ ‘We can – and must – do better’ With its €10 million funding from the French National Cancer In- stitute (INCa), supported by social security and regional health auth- orities, IMPULSION pro- gramme will initially include only five regions in 2025, with a national rollout envisioned for 2026. the Revel‘s team is exploring the po- tential of ultra-low dose scanning technology, testing whether radi- ation exposure equivalent to a chest X-ray can still yield ac- tionable diagnostic data without compromising AI performance. ‘The scanner is still an irradiating tool, but we can – and must – do better,’ she emphasized. For Revel, who lost her cousin to lung cancer, the new programme is also a very personal matter. She herself underwent screening and is constantly looking for new ways to reach wider audiences. ‘Science matters,’ she said. ‘But if you want to change society, it’s stories – not statistics – that move people.’ As Europe is redoubling its efforts for lung cancer screening, IMPUL- SION could become a model for implementing precision medicine while increasing health equity. And in the words of its creator, it is not just about saving lungs, but about saving lives. ■ Author: Mélisande Rouger Marie-Pierre Revel Marie-Pierre Revel is a professor of radiology at Université de Paris and Head of the Imaging Department at Cochin Hospital in Paris, France. She is a past president of the European Society of Thoracic Imaging (ESTI) and the deputy Vice-President of the European Society of Radiology. Low-dose chest CT may detect more than just lung cancer lung Pan-European cancer screening is challenged due to the range of approaches in dif- ferent countries. As attitudes to- wards smoking and smoking cessation programmes vary, ex- perts are attempting to establish more unified lung cancer screen- ing. The introduction of con- sistent lung cancer screening will be outlined at a special session during the online ECR 2021, with presenta- tions highlighting the current position in several countries. pan-European As new research in CMAJ (Cana- dian Medical Association Journal) shows, these CTs can identify cor- onary artery calcium, a strong risk factor for coronary artery disease (CAD), in patients without cardiac symptoms. “Lung cancer screening, although primarily geared towards reducing lung cancer, also has an opportunity to deaths from ) 0 . 4 D N - C N - Y B C C ( 4 2 0 2 J A M C , . l a t e C M s e r i a C : e c r u o s e g a m I Coronary artery calcification on low-dose chest CT.. Transaxial image of a lung cancer screening CT scan, showing coronary artery calcium in all 3 coronary arteries. LAD = left anterior descending artery, LCX = left circumflex artery, RCA = right coronary artery. help tackle the second most com- mon cause of premature death in through middle-aged the risk stratification of coronary atheros- identification adults, and clerosis,” writes Dr. Gary Small, University of Ottawa Heart In- stitute. In a study of 1486 patients The success of this pilot program will be affected by how clinicians interpret and manage findings of coronary artery calcium. However, clinicians must be aware that there could be harms such as inappropri- ate investigation after coincidental detection. The authors urge more research into how to manage patients with coincidentally detected coronary artery calcium but suggest “con- tinued attention to cardiovascular disease prevention is warranted and could be amalgamated into lung cancer screening initiatives to promote health.” ■ Source: Canadian Medical Association Journal screened for lung cancer between March 2017 and November 2018 as part of the Ontario Health Lung Cancer Screening Pilot for People at High Risk, coronary artery cal- cium was detected in 83% (1232) of patients, with high levels in 30% (439). More than half of patients (52%) were male, mean age was 66 years, and 68% (1017) were current smokers. As lung cancer is the leading cause of cancer deaths in Canada, screen- ing programs have introduced low- dose CT for people at risk of lung cancer. These CTs can also easily identify coronary calcification, a marker of coronary artery disease, the most common cause of cardiac death. “If appropriate therapeutic responses are instituted, lung CT findings could affect survival from two leading causes of death: lung cancer and coronary artery dis- ease,” the authors write. EH @ MEDICA 2025
EH @ MEDICA 7 Conversational AI in medicine How to teach an LLM to think like a clinician While generative AI shows im- mense potential for healthcare, a critical reliability issue lurks be- neath the surface: LLMs don‘t think like doctors do, a data science expert explained at the Emerging Technologies in Medi- cine (ETIM) congress in Essen. This potentially fatal flaw, how- ever, may be fixable. From patient communication to clinical decision support and auto- mated reporting – Prof. Michael Gertz pointed out how LLMs show great promise to be of help for clinicians at almost every task across the patient journey.1 How- ever, the models suffer from fluc- tuating performance and therefore lack the reliability needed for sen- sitive healthcare applications, ex- plained the Head of the Data Science Group at Heidelberg Uni- versity.2 To understand the frequent inac- curacies within the AI output, ‘it is important to keep in mind that an LLM is basically just a machine for next word prediction’, Gertz said. While this may be useful for tasks requiring a certain degree of cre- ativity, it can lead to potentially se- vere errors in a medical context. ‘LLMs demonstrate remarkable lan- guage generation skills, which can easily be mistaken for genuine rea- soning,’ the expert cautioned. ‘In high-stakes domains like medicine, this illusion can lead to real harm. This is why, despite their promise, these models must be integrated carefully, with human oversight and robust methods for verifying correctness and sources.’ Taking it one step at a time Efforts to improve the reliability of LLM output include careful prompt engineering, using advanced tech- niques such as retrieval-augmented generation (RAG) and thorough fine-tuning of results in safe testing environments. these methods, it is possible to guide the AI models ap- proximation of clinical reasoning, Gertz suggested. This includes con- cepts such as evidence-based deci- sion-making, pattern recognition, and probabilistic thinking. towards Using an A suitable way to introduce an LLM to this line of reasoning can be through chain-of-thought (CoT) – a method derived from the struc- tured interviews performed in psy- chotherapy, the expert explained. Basically, this replaces the LLM’s associative default mode of oper- ation with a more thorough step- by-step approach. Adopting this format, an LLM can be trained to follow decision trees, eventually leading to a way of reasoning closer to that of a clinician using causal chains before coming to a diagnosis.3 the Transparent attribution is key While aforementioned measures reduce the likelihood of AI-generated “hallucinations”, sev- eral challenges with current LLMs must be addressed before safe adoption in a medical setting, Gertz said. For one, the models are often trained on huge, uncurated datasets. This makes pinpointing the origin of a single statement nearly impossible. ‘In healthcare, trust and accountability hinge on traceability,’ the expert stressed. ‘Clinicians and patients want to know where a given piece of in- formation is coming from – from a peer-reviewed study, a reputable guideline, or just online chatter?’ Consequently, thorough and trans- parent attribution of sources is vital – especially so considering that current models tend to simply in- vent citations to support state- ments, thus posing a serious ethi- cal and practical problem medical contexts, Gertz added. in Further issues include significant drops in LLM reliability when the models are confronted with novel or complex circumstances and the as-of-yet unclear legal responsibil- ity in case of faulty medical advice. ‘For the foreseeable future, there will always have to be a human in the loop’, Gertz concluded – ‘a medical professional to interpret and validate outputs before any critical decision-making.’ ■ Author: Wolfgang Behrends Sources: 3 Liévin V, Hother CE, Motzfeldt AG, Winther O: Can large language models reason about medical ques- tions?; arXiv 2023; https://doi.org/ 10.48550/arXiv.2207.08143 preprint Michael Gertz 1 Bhayana R: Chatbots and Large Language Models in Radiology: A Practical Primer for Clinical and Research Applications; Radiology 2024; https://doi.org/ 10.1148/radiol.232756 2 Gupta M, Virostko J, Kaufmann C: Large language models in radiol- ogy: Fluctuating performance and decreasing discordance over time; European Journal of Radiology 2025; https://doi.org/ 10.1016/j.ejrad.2024.111842 Michael Gertz is a full professor at Heidelberg University where he heads the Data Science Group at the faculty of Mathematics and Com- puter Science. From 1997 until 2008 he was a faculty at Department of Computer Science at the University of California at Davis. His interdisci- plinary research interests include natural language processing, AI, complex networks, and scientific data management, with applications in the medical sciences, law, physics, political sciences, and economics. Meet Italy at Medica 2025 Messe Düsseldorf · 17. - 20. November 2025 Hall 15 · Booths A 23 – A 33 – B 23 – B 24 B 33 – B 34 – C 24 – C 32 EH @ MEDICA 2025 Ministero degli Affari Esteri e della Cooperazione Internazionale
8 EH @ MEDICA Imaging modality comparison presented at RSNA 2024 Photon-counting CT advances identification of pancreatic cystic lesions Pancreatic cystic lesions – indi- cating an increased risk of pan- creatic cancer – are an occasional incidental finding in routine computed tomography (CT) ab- dominal imaging. New research suggests that the superior image quality of photon-counting CT (PCCT) can help detect more of these lesions. At the RSNA an- nual meeting, an expert outlined the benefits and limitations of the imaging technique for early detection. Patients with pancreatic cysts may be at increased risk for pancreatic cancer. Therefore, an MRI scan with intravenous contrast for fol- low-up of incidental cystic lesions is usually performed, and guide- lines recommend follow-up CT im- aging on an ongoing basis. The lesions are only identified as incidental findings in fewer than 3% of routine abdominal CT scans performed, compared to up to 44.7% in MRI examinations. Recent research at multiple academic centres explores the effect of im- proved CT image quality on detec- tion rates for pancreatic cystic lesions. 1 the Researchers at the University of Freiburg evaluated image quality and diagnostic accuracy of PCCT compared to conventional energy-integrating detector CT (EID-CT), with MRI serving as the reference standard. They reported at a RSNA 2024 scientific session that PCCT does improve detection and delineation, particularly for smaller cystic lesions. Additional benefits significantly lower radiation exposure while included producing higher image quality and generating higher diagnostic confidence by readers. 2 Improved differentiation Principal investigator Stephan Rau, MD, and colleagues’ database in- cluded 106 consecutive patients with a median age of 62.7 years, who had a portal venous ab- dominal PCCT, an EID-CT, and a multi-parametric abdominal MRI performed within a six-month peri- od. A total of 46 simple cystic lesions were confirmed on MRI: 14 greater than 10 mm, and 27 be- tween 5 mm to 9.99 mm in size. The researchers assessed diag- nostic accuracy, and qualitative and quantitative image accuracy. Dr Rau reported image quality, lesion conspicuity, and diagnostic confidence were rated superior for PCCT vs. EID-CT on 5-point Likert scales by three independent radi- ologists in a blinded reading. Sen- sitivity for the detection of cystic lesions was significantly higher for PCCT for all lesion categories: 76.8% vs 59.4% overall, 86.4% vs 71.6% for lesions 5 mm to 9.99 mm in size, 90.5% vs. 83.3% for lesions equal or greater than 10 mm. Photon-counting CT also provided better material decomposition, re- sulting in higher cystic paren- chyma contrast. ‘From my point of view, this is the most interesting finding of the study,’ Dr Rau commented. ‘It shows that PCCT provides better evaluation of cysts components, in this fluids. Thereby, a new possibility for fu- ture studies on differentiation of case, water-like cystic lesions based on their at- tenuation/material decomposition could be feasible and should be evaluated.’ Complimenting MRI, not replacing it ‘The University of Freiburg has al- ready integrated PCCT technology for clinical applications, including abdominal imaging,’ Dr Rau told European Hospital. ‘The results of the study underline its value in im- proving diagnostic workflows for detecting pancreatic cystic lesions, especially in routine scenarios or where MRI access is restricted. Adoption for broader use in the specific context of pancreatic cystic lesions detection will likely depend on further advancements, includ- ing multispectral imaging capabil- ities for lesion characterisation.’ Asked about the potential of PCCT as an appropriate substitute for MRI, Dr Rau advised, ’MRI remains the reference standard, particularly due to its superior contrast resol- ution and ability to characterise cystic lesions in greater detail, such as distinguishing malignant from benign features. MRI’s unmatched soft tissue contrast, especially on T2-weighted sequences and dif- fusion weighted imaging, is critical for pancreatic cystic lesion evaluation.’ comprehensive He added, ‘MRI remains indispens- able for follow-up imaging or cases with non-conclusive CT findings. And it does not use ionizing radi- ation.’ Dr Rau believes that PCCT, with its higher image quality and lower radiation dose, demonstrates great promise as a complimentary tool to MRI. ‘It may even be a sub- stitute on scenarios where MRI 2. Rau S, Stein T, Rau A, et al. De- tection of cystic lesions of the pan- creas: Imge quality and diagnostic accuracy of photon-counting de- tector conventional energy- integrating detector CT |T1-SSG09–01. 2024 RSNA Meet- ing Central. Accessed online 26 Ja- nuary 2025. https://reg.meeting. rsna.org/flow/rsna/ rsna24/AttendeePort- alRSNA2024/page/ sessioncatalogap/ session/1719441285462001hlC8 availability is limited, or patients are contraindicated for MRI,’ he said. Diagnostic boon, but a burden on workload But while PCCT’s higher sensitivity for detecting small pancreatic lesions is a significant advantage, this technology has brought a new challenge: what should radiologists do about these increasingly com- mon incidental findings? Dr Rau explains that current guide- lines, based on conventional CT technology, recommend follow-up imaging for all pancreatic cystic lesions. ‘This approach may im- pose a substantial burden on healthcare systems without clear evidence of benefit. Balancing early detection with the cost and practicality of follow up care is an important consideration for future research and policy discussions.’ ■ Author: Cynthia E. Keen Stephan Rau Stephan Rau, MD, is a radiologist specializing in computed to- mography at the Clinic for Diagnostic and Interventional Radiology at the University of Freiburg, Germany. He has conducted extensive research in the diagnostic capabilities of photon- counting detector CT technology. His clinical research includes PCCT im- aging of cystic renal lesions, the spine, head and neck scans in pa- tients with dental hardware, multiple myeloma, and of patients with metal artefacts. References: 1 Dane B, Kim J, Qian K, et al. Pan- creatic cystic prevalence and de- tection with photon counting CT versus conventional energy inte- grating detector CT. Eur J Radiol. 2024;175:111437. doi: 10.1016/j.ejrad.2024.111437 NEWS ∙ REPORTS ∙ INTERVIEWS ∙ VIDEOS ∙ SOCIAL MEDIA S a y i n f rm e d EH @ MEDICA 2025
EH @ MEDICA 9 Detection of neurodegenerative condition Developing blood biomarkers to diagnose Alzheimer’s disease ary 2025. https://www.alzint.org/ about/dementia-facts-figures/ dementia-statistics. 3 Highlights from the Alzheimer’s Association International Con- ference. JAMA Podcast – August 16, 2024. JN Learning – AMA Hub. Last accessed 2025. https://edhub.ama-assn.org/jn- learning/audio-player/ 18904877?resultClick=3 January 10 4 Pascoal TA, Aguzzoli CS, Lussier FZ, et al. Insights into the use of biomarkers in clinical trials in Alz- heimer’s disease. EBioMedicine. 2024 Oct;108:105322. doi: 10.1016/j.ebiom.2024.105322. 5 BEST (Biomarkers, EndpointS, and other Tools) Resource [Inter- net]. Last accessed 24 January 2025. https://www.ncbi.nlm.nih. gov/books/NBK338449. 6 Salloway S, Rowe C, Burns JM. Are Blood Tests for Alzheimer Dis- ease Ready for Prime Time? JAMA. 2024;332(15):1240–1241. doi:10.1001/jama.2024.12814. Pittsburgh, along with an inter- national team of co-authors, state that ‚the importance of biomarkers in drug development is growing exponentially‘ and that they ‚are expected to serve a wide range of contexts of use in clinical trials fo- cusing on AD and other demen- tias.‘ 4 ‚The lack of biomarkers for popu- lation selection [of early clinical trials targeting Amyloid-beta] has raised the possibility that their negative results could be because other brain pathologies, unaffected by the drugs being studied, were causing symptoms in many partici- pants,‘ they write. ‚Furthermore, the lack of biomarkers to track therapeutic response has raised questions about whether drugs reach their targets and produce the expected biological effects. The lessons learned from these clinical trials have highlighted that it is im- perative to use biomarkers for more informative drug devel- opment in the field of AD.‘ Categories and complexities Blood biomarkers for AD do not have a single category, but three. The first class includes biomarkers associated with the presence of beta-Amyloid plaques and p-tau tangles, both of which are classic pathological hallmarks. The second class is associated with neuronal loss, neurodegeneration, or syn- aptic degeneration. The third class includes processes to neuroinflammation related to glial cells. related The US Food and Drug Adminis- tration and National Institutes of Health created a Biomarker Work- ing Group in 2016, which defined and established nine types of biomarkers. These are categorized in diagnostic, predictive, prog- nostic, response, monitoring, and safety categories.5 Diagnostic biomarkers are most publicly associated with blood laboratory tests being used in clini- cal trials and in development. susceptibility, Better diagnostics lead to increased need for care Assuming that blood biomarker tests become clinically approved and low in cost, what then? Com- menting about the accuracy of the blood plasma test used in the Swedish clinical trial in a JAMA edi- torial, dementia specialist phys- icians the United States point out the need for a significant increase in nurse practitioners, nurses, and care navigators.6 from Australia and Lead author Stephen Salloway, MD, of the Departments of Psychiatry and Neurology of Warren Alpert Medical School of Brown Univer- sity in Providence, Rhode Island, and co-authors write, ‚Advances in the diagnosis and treatment of Alz- heimer disease will require import- ant changes to care models. It will not be possible to provide high- quality dementia care in a new molecular era within the already overburdened practice settings without providing additional re- sources and staffing.’ This by itself is a huge challenge, and is not being achieved to effec- tively deal with the needs of today’s AD patients and their care- givers, even though an estimated $1.3 trillion is being spent, accord- ing to ADI. ■ Author: Cynthia E. Keen Sebastian Palmqvist, MD, PhD is Associate Professor in the Clinical Memory Research Unit at Lund Uni- versity. He also is a Consultant Neur- ologist at Skåne University Hospital in Malmö, Sweden. Palmqvist is prin- cipal investigator of ADetect, a 24 month long AD detection study launched in January 2024, and a re- search participant in Lund University ongoing EDAP (early prognostics of Alzheimer’s disease) project. References: 1 Palmqvist S, Tideman P, Mattsson- Carlgren N, et al. Blood Biomarkers to Detect Alzheimer Disease in Pri- mary Care and Secondary Care. JAMA. 2024:332(15):1245–1257. doi:10.1001/jama.2024.13855. 2 ‚Dementia statistics‘. Last ac- cessed from Alzheimer’s Disease International website on 22 Janu- to enter There is no known cure for Alz- heimer’s disease (AD), although prescription drug-based treat- ments that can slow AD progres- sion in some patients are start- ing clinical use. Biomarkers, quantifiable char- acteristics of biological pro- cesses or pathological con- ditions, are making it possible to help identify and measure the presence and extent of AD and its degenerative progression. A blood plasma biomarker test re- ceived international media at- tention in July 2024 when results of a large clinical trial showed it to be 91% accurate in diagnosing AD in patients who had been clinically evaluated and diagnosed, com- pared to 73% by dementia special- ists and 61% by primary care phys- icians. The study involved 17 primary care centres in Sweden treating 1,213 patients over 65 years old experi- encing symptoms ranging from subjective cognitive decline to de- mentia. Half had pathologically confirmed AD.1 secondary and The significance of this research becomes clear in light of experts predicting that in 2025, 10 million people will develop AD. Leading organisation Alzheimer’s Disease International (ADI) further esti- mates that the disease will escalate from 55 million cases worldwide to 78 million by 2030 and more than 139 million cases by 2050.2 Benefits for diagnostics and research When blood biomarker tests for AD do become clinically available, unlike the current testing methods of expensive positron electron to- mography (PET) imaging scans and invasive lumbar spine punc- ture for a cerebrospinal fluid test, they will offer many advantages. These are expected to be wide- spread availability, low cost, easy acquisition from patients, and ac- curate laboratory analysis. But they are not going to be a commonplace screening tool soon. Many clinical research challenges await. Sebastian Palmqvist, MD, PhD, Associate Professor in the Clinical Memory Research Unit at Lund University and principal in- vestigator of the Swedish study, ad- vised during a JAMA Medical News podcast that the test is not a stand- alone diagnostic AD test, but rather something that should accompany the standard clinical evaluation. However, he emphasized that ‚you need biomarker tools to accurately identify AD, because the clinical symptoms aren‘t specific for that disease and can be caused by many other ideologies.3 aid tests will greatly The development of blood biom- arker drug-related clinical trials. In a re- view on this topic, lead author Tha- rick A. Pascoal, MD, PhD, an As- sociate Professor of Psychiatry and Neurology at the University of EH @ MEDICA 2025
10 Medica partner EH @ MEDICA Interview with Jan Wolter: shaping the future of laboratory medicine Jan Wolter has been the auth- orised representative of the executive committee of the Ger- man Society for Clinical Chemis- try and Laboratory Medicine (DGKL) for over two years. He is focusing on more public re- lations work and broader com- munication on the subject of lab- oratory medicine – including via the MedLabPortal, founded in 2024. In this interview, he talks about successful conferences, the critical situation in the USA and AI in laboratories. Mr Wolter, MedLabPortal, the in- formation portal of the German Society for Clinical Chemistry and Medicine (DGKL), was an ideal partner for the MEDICA LABMED FORUM 2024. What are your plans for this year? Laboratory WOLTER: The DGKL will be present at MEDICA again this year and will focus on key topics that we also cover on the MedLabPortal. In the field of laboratory medi- cine, the DGKL, publisher of MedLabPortal, is an indispens- able scientific and medical as- sociation. Who else do you want to reach with the cooperation with Medica outlined earlier? WOLTER: As a professional as- sociation, we organise our own large, successful flagship event, the German Congress for Laboratory Medicine, which will take place next year on 1 and 2 October in Hamburg, as well as other events. Through Medica, we can also reach people who might not travel to Leipzig or Hamburg for a full-day or two-day event to learn about laboratory medicine. We can see that this strategy is working be- cause both our own events and Medica are well attended. Last October, you presented the MedLabAwards in Leipzig. What is the idea behind focusing the DGKL awards under this umbrel- la? WOLTER: Laboratory medicine is an exciting, highly innovative field that is indispensable for medical care. Yet it often remains invisible to the public. This is because pa- tients have little direct contact with it. For an MRI, you go to the radi- ologist and lie down in the ma- chine. However, your GP takes the blood sample and sends it away. He then presents the results to you. We need to put laboratory medicine more in the spotlight and make its successes and innovations better known – and we should also celebrate them from time to time. The MedLabAwards provide the stage for this. Of course, we also want to promote young talent and inspire enthusiasm for the field. Speaking of young talent: scien- tific and medical institutions and universities in the USA are cur- rently under enormous pressure. What impact does this have on German laboratory medicine? WOLTER: For laboratory medicine, this could of course be an oppor- tunity to poach researchers from the USA. However, the framework conditions for this must be created here. Universities would need to be better equipped and, above all, better funded. Bureaucracy is also a problem. Even if it jeopardises your next trip to the USA as a tourist, we would like to hear more about that... WOLTER: I also really enjoy spend- ing holidays in Canada. But to answer your question: science is under enormous pressure in the USA and is even seen as the enemy in some quarters. We need to posi- tion ourselves here as a clear counterpoint, where science is free. Unfortunately, I also see trends here in this country where facts are being given less and less importance. And so, in your view, Medica could be a platform on which the DGKL, with its MedLabPortal, could become the voice of free science? WOLTER: That should already be the case! In any case, I can encourage scientists from laboratory medicine and clinical chemistry to recognise the MedLabPortal as an oppor- tunity to disseminate their topics and research results. As you know, we like to provoke: in Germany, there is a lot of talk, even more announcements, but in the end, little is implemented. Does this also apply to labora- tory medicine? WOLTER: Especially in areas like digitalisation and automation – often discussed in Germany but rarely implemented – laboratory medicine is moving comparatively fast. The DGKL is also pushing these issues forward and digitalis- ing and automating processes within the professional association. Speaking of AI and digitali- sation, you have recruited some very high-calibre and talented experts from the DGKL‘s Young Laboratory group to drive the digitalisation of forward the professional association. That is commendable – but do you also have any suggestions regarding cyber security? The threat is global, and the pressure is not only coming from the USA... WOLTER: We have repeatedly pointed out that more attention needs to be paid to this issue and have exchanged views with the Federal Office for the Protection of the Constitution, among others. To be able to finance more security, I proposed the Cybercent. This in- volves adding a minimal surcharge to each sample. The money goes into a pot from which security measures are promoted or fi- nanced. You yourself are one of the best- known security experts in Ger- many and were managing direc- tor of an association whose cooperation partners included institutions such as the BKA, BND, BfV and BSI. How should laboratory medicine, which is after all considered critical infra- structure, prepare itself for the future in terms of security? WOLTER: Thank you for the com- pliment, but you are overestimat- ing my level of fame. The fact is, however, that laboratory medicine is undoubtedly a critical infra- structure and therefore a focus of attention. I don‘t even want to go into the scenarios that are conceiv- able here and the players that could get involved. As a home sec- retary once said, „The answer could alarm the population.“ Above all, I don‘t want to give any- one any ideas or suggestions. Lab- oratory medicine would therefore be well advised to protect itself at a military level. Software and hard- ware naturally play an important role here, but particular focus should be placed on employees. They need to be made aware of the issues. For many, what is not only possible today, but also common modus operandi still sounds like science fiction or James Bond. Our last question, because Fed- eral Health Minister Nina Warken will probably read this interview: What would you like to tell her? WOLTER: Politicians tend to only ad- dress an issue once it has become a problem, once something is no longer working. Or when someone comes up with the idea that it could help solve another problem. Therefore, laboratory medicine could be key to solving many prob- lems. Without better conditions, however, it risks becoming a prob- lem itself. If you would like to know more about this, you should talk to independent practitioners and scientists in the field of labora- tory medicine. You will find them here with us. Mr Wolter, thank you very much for your time. - Questions asked by Marita Voll- born and Vlad Georgescu – ■ Source: Messe Düsseldorf Jan Wolter Jan Wolter leads the DGKL office, drawing on broad experience in as- sociation management and health- care policy. Previously, he held leadership roles at Spectaris and the Alliance for Security in Business. His strategic and communication skills continue to strengthen DGKL’s pres- ence in the public and political arenas. Publisher mgo fachverlage GmbH & Co. KG E.-C.-Baumann-Str. 5 95326 Kulmbach/Germany Phone +49 (0) 9221 949-311 Fax +49 (0) 9221 949-377 Managing Directors: Eva-Maria Bauch, Stephan Behrens Editor and Production Manager: Tim Hofmann (TH) Phone: +49 (0) 9221 949-176 E-Mail: redaktion@european-hospital.com Editor: Wolfgang Behrends (WB) Founded by Heinz-Jürgen Witzke ISSN 0942-9085 USA: Cynthia E. Keen (CEK) Correspondents Austria: Michael Krassnitzer (MK) Germany: Cornelia Wels-Maug (CWM) Dr Christina Czeschik (CC) Great Britain: Mark Nicholls (MN) Spain: Mélisande Rouger (MR) Subscriptions Simone Sesselmann kundenservice@mgo-fachverlage.de Subscription rate 4 issues: 32 Euro, Single copy: 8 Euro. Publication frequency: quarterly Representatives Germany, Austria, Switzerland: Diana Thümmel Phone: +49 9221 949-407 E-Mail: d.thuemmel@mgo-fachverlage.de Europe: Eric Jund Phone: +33 493 58 77 43 E-Mail: jund@european-hospital.com Taiwan: Charles Yang Phone: +886 4 232 236 33 E-Mail: medianet@ms13.hinet.net USA & Canada: Hanna Politis, Media International Phone: +1 301 869 66 10 E-Mail: hanna@media-intl.com All company, brand and product names in this publication are the property of their respective holders. Users must obtain per- mission from those holders before copying or using the owner’s trademarks, product and company names or logos. EH @ MEDICA 2025
EH @ MEDICA 11 Precision approach through the eye socket Orbital gateway to surgical removal of brain tumours Mr Asim Sheikh Mr Asim Sheikh is Consultant Neur- osurgeon with subspecialist expertise in skull base and neurovascular sur- gery at the Leeds General Infirmary. His specialist interests include endo- scopic endonasal skull base surgery, open skull base neurosurgery, mini- mal access surgery and brain tumour surgery. He is a member of the Royal College of Surgeons of England, the Society of British Neurological Sur- geons and the British Neurovascular group. 2023. Neurosurgeons in New York further developed the approach, which is now being taught to specialists in Oxford, Bristol, Edin- burgh, and Liverpool. The Leeds team has successfully performed six such operations for tumours. Mr. Sheikh explained that this approach offers the ability to remove tumours that were pre- viously thought difficult to remove, or even inoperable. Substantial benefits for patients Depending on tumour size and consistency, the procedure takes 4–10 hours under general anaes- thesia. While there is a risk to af- fect the patient’s eyesight, Mr. Sheikh explains their technique minimizes this concern: ‘In our technique, we create room by re- moving a portion of the outer wall of eye socket and that minimises this risk. We have not had any vis- ual complications so far.’ The benefits to patients have been reported to be substantial: quicker recovery, early mobilization, faster discharge home, reduced risk of brain injury, and superior access to deep-seated tumours. As this tech- nique continues to develop, it rep- resents a significant advancement in the treatment of complex brain tumours, offering hope to patients who previously had limited op- tions, the team summarizes. ■ Article: Mark Nicholls Happy hour & networking event Connect with Estonia’s top HealthTech companies Tuesday, 18 November | 16:00 Estonian National Pavilion Hall 15 | Stand D24 h k i e h S m i s A © Using 3D models of their patient’s anatomy, the surgeons prepare the optimal access to the brain tumour. Using a keyhole surgery ap- proach, surgeons have found a new way to access previously difficult-to-reach brain regions with faster recovery times. With the help of 3D modelling tech- nology, the neurosurgeons suc- ceeded in removing complex tu- mours from the cavernous sinus through the eye socket, avoiding complex brain surgery and en- abling their patients to make a quicker recovery. ‘The primary advantage is that it provides direct access to the cav- ernous sinus, which was once thought to be an inaccessible area,’ explains Consultant Neurosurgeon Asim Sheikh from Leeds Teaching Hospitals Trust in the UK, one of the European centres performing this procedure. ‘This allows safer removal of tumours without the risk of injuring or retracting brain tissue, which would otherwise be required with traditional cran- iotomy.’ The procedure begins with a small 1–1.5 cm incision at the outer edge of the eye, followed by an internal incision within the eye lining to ac- cess the bones. Surgeons then care- fully cut a small segment of bone in the outer wall of the eye socket, keeping it attached to tissues and muscles while pushing it outward to create space for surgical in- struments. The final step involves drilling the back wall of the eye socket to gain access to the tu- mour. This minimally invasive approach leaves patients with only a tiny scar near the eye, reducing recovery time drastically. The first UK pa- tient – a 40-year-old stroke nurse with a meningioma in the cavern- ous sinus – returned to work swiftly, within just three months of her surgery. 3D technology for optimal preparation Given the procedure‘s complexity, surgeons at Leeds utilized ad- vanced 3D modelling technology to rehearse the operation before entering the OR, building a 1:1 scale model to plan the surgery. Mr. Sheikh, who works alongside Consultant Maxillofacial Surgeon Jiten Parmer, added that prepara- tion involves neuro-navigation software with 3D segmentation of all structures to virtually perform the surgery, complemented by practice sessions in the cadaver lab. Lisa Ferrie, the Trust‘s Biomedical Engineer and 3D Planning Service Lead, notes that the 3D technology enables the surgical team to study patient anatomy and prepare for the procedure ‘with unparalleled accuracy,’ significantly enhancing surgical precision. Previously, an operation to remove such a tumour would require com- plex brain surgery involving cran- iotomy and taking a large part of the skull away – risking com- plications that could include brain injury and seizures, Sheikh said. ‘It’s a hard-to-reach area,’ he con- tinued, ‘but this new approach allows direct access without any compromise of pressure on the brain. We can now reach areas which were once thought to be in- operable, but now are accessible.’ Initially established for trauma pa- tients, the technique was adapted for brain tumour surgery by teams in South Korea and Barcelona, Spain – where Mr. Sheikh trained before introducing it to Leeds in A segment of bone is cut and pushed outward to make space, followed by drilling the back wall to access a tumor. EH @ MEDICA 2025 h k i e h S m i s A © tradewithestonia.com
12 EH @ MEDICA Paediatric trauma in diagnostic imaging ‘It only takes one radiologist to stop child abuse’ identify Covid-19 has intensified do- mestic violence rates worldwide, with children among the most vulnerable victims. At the ECR 2025 radiology congress in Vien- na, Prof Dr Rick R. Van Rijn pres- ented insights into how radi- ologists can injuries for non-accidental suspicious trauma children through systematic imaging ap- proaches. From comprehensive skeletal surveys to specific neur- ological imaging protocols, the expert explained how these tech- niques are essential for early di- agnosis, enabling timely and po- tentially life-saving intervention. (NAT) in The WHO reports that six out of ten children under age five – ap- proximately 400 million worldwide – regularly experience violence from parents or caregivers. Data from the Netherlands show that one in 30 children suffer from a form of abuse, of them a quarter are reported to be the victim of physical abuse. Van Rijn, a paedia- tric forensic radiologist at the Am- sterdam University Medical Center (UMC) and Netherlands Forensic Institute, highlighted that child abuse, particularly abusive head trauma, is a major contributor to fatalities, disabilities, and devel- opmental challenges in infants.1 However, he pointed out that many hospitals still do not have con- sistent procedures in place for ad- dressing suspected cases. Europe‘s guideline, “The Radiologi- cal Investigation of Suspected Physical Abuse in Children,” estab- lishes a standard for best practices. However, it sets demanding crite- ria, such as requiring double read- ing or forensically trained radiogra- phers – a standard that remains hard to obtain in many countries. ‘What any radiologist can do, re- gardless of specialization, is ensure radiographs sufficient quality for expert review,’ Van Rijn advised. are of Recognizing red flags First of all, it is important to recog- nise possible signs of abuse. The „TEN-4-FACESp“ rule provides radiologists with a systematic ap- proach to identifying suspicious bruising in children under the age of 4 years. TEN-4-FACESp2 stands for bruising to the Torso, Ears, Neck, Frenu- ternational consensus statement published in JAMA Pediatrics4, all contact children, i.e. siblings or other children in the same house- hold, should be screened based on age-specific protocols: If no findings indicative of abuse are observed at physical examin- ation or based on clinical history, the child is screened as a contact child using age-based protocols: • Under 1 year: Perform a brain MRI (adding spine MRI if brain findings are abnormal) and a full skeletal survey. • Ages 1–2 years: Perform a full skeletal survey. • Ages 2–5 years: No radiological required unless screening physical findings suggest abuse. is The 35 radiographs recommended by „The Radiological Investigation of Suspected Physical Abuse in Children”. n j i R n a v k c i R © If findings indicative of abuse are present, the child is investigated as per (inter)national guidelines for an index case. patterned lum, Angle of the jaw, Cheeks, Eye- lids or Subconjunctivae, “4” repre- sents infants four months and younger with any bruise, any- where, and “p” means the presence of bruising. ‘Any of these signs should immedi- ately raise concerns,’ Van Rijn stated. He recounted a tragic case where medical professionals dis- missed unexplained bruising in an infant who later died from abuse, underscoring the life-or-death im- portance of vigilance. Inconsistencies in reported history or trauma mechanism provide an- other crucial warning sign. ‘When parents a 4-month-old walked and fell, that‘s immediately suspicious since children typically begin walking around eleven months,’ he explained. claim Comprehensive imaging: the critical first step A proper skeletal survey requires 35 radiographs of the child – a standard that cannot be compro- mised. ‘If you miss minor fractures, you risk missing child abuse,’ Van Rijn warned. This thoroughness is justified by statistics: one-third of children under the age of 2 years examined for a reported fracture have additional unreported frac- tures, and 40% of abusive head trauma cases reveal additional frac- tures elsewhere in the body.3 The follow-up skeletal survey, con- ducted after two weeks, requires fewer images but remains, even if the first skeletal survey is negative, essential. At the follow-up, radio- graphs should include the chest in three directions, upper and lower arms, upper and lower legs, and spot radiographs of areas with in- itial concerns or identified meta- physeal fractures. Van Rijn illustrated the importance of this with a case of a 7-week-old with whooping cough whose fol- low-up radiographs revealed heal- ing posterior rib fractures only vis- ible after callus formation had begun – a clear indicator of pre- vious trauma that would have otherwise gone undetected. ‘This meticulous approach to fol- low-up imaging ensures that no signs of healing trauma are missed, providing critical evidence for identifying abuse. However, im- aging should not stop at skeletal surveys – neurological imaging plays an equally vital role in un- covering hidden patterns of abuse.’ imaging Advanced neurological imaging: beyond the obvious Neurological extends beyond cases with clear symptoms of abuse. ‘This isn‘t just for clinical findings but for forensic purposes,’ Van Rijn clarified. ‘There‘s a strong pattern of recurrent trauma in these cases.’ Neurological imaging is essential in two key scenarios: when a child presents with neurological symp- toms, and even when no neurologi- cal symptoms are apparent but physical abuse is suspected in an infant. Van Rijn underscored the importance of imaging in the latter scenario by recounting a chilling example from a French study. ‘In some cases, caregivers admitted to shaking their child to make them stop crying. It worked – until one day, the child didn’t wake up any- more. It died,’ he explained. Van Rijn emphasized the import- ance of neurological imaging for forensic purposes. This evidence provides an entry point to engage with parents and offer support. ‘No one wakes up and says, “I will kill my child.” We know that there are certain risk factors associated with an increased risk of child abuse, understanding identifying these factors should lead to ad- equate interventions helping both the child as well as the parents/ caregivers. and Protecting the siblings: extending the safety net When abuse is identified, the in- vestigation shouldn‘t stop with the index patient. According to the in- A call to action ‘It only takes one radiologist to stop child abuse,’ Van Rijn con- cluded, noting that an international consensus guideline for imaging in suspected child physical abuse (IGISPA) is in development. His message was clear: radiologists armed with proper protocols and vigilance can make life-changing – and potentially life-saving – dif- ferences for vulnerable children. ■ Author: Tim Hofmann Rick R. van Rijn Rick R. van Rijn is a professor of forensic radiology at Emma Children’s Hospital – Amsterdam UMC, specializing in paediatric and forensic imaging. A leader in his field, he has published over 250 ar- ticles, chaired major radiology so- cieties, and was named an honorary fellow of the Royal College of Radi- ologists in 2025. 1 Felitti VJ, Anda RF, Nordenberg D et al.: Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study; American Journal of Pre- ventive Medicine 1998; https://doi. org/10.1016/s0749–3797(98)00017 –8 2 Pierce MC, Kaczor K, Lorenz DJ et al.: Validation of a Clinical Decision Rule to Predict Abuse in Young Children Based on Bruising Characteristics; JAMA Network Open 2021; https://doi.org /10.1001/jamanetworkopen.2021.5832 3 Loos MLHJ, Ahmed T, Bakx R, van Rijn RR: Prevalence and distribution of occult fractures on skeletal surveys in children with suspected non-accidental trauma imaged or reviewed in a tertiary Dutch hospital; Pediatric Surgery Inter- national 2020;36:1009–1017; https://doi.org/10.1007/s00383–020–04 706-z 4Mankad K, Sidpra J, Mirsky DM et al.: International consensus statement on the radiological screening of contact children in the context of suspected child physical abuse; JAMA Pediatrics 2023;177:526–533;https://doi.org/10.10 01/jamapediatrics.2022.6184 EH @ MEDICA 2025