Laws & regulations

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News • PTB approval for Mako platform

Highest certification for X-ray dosimeter

The RTI Mako achieved one of the highest levels of certification for an X-ray dosimeter with PTB approval, marking a major milestone in the continued evolution of the Mako platform.

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Article • The future of the EU Medical Device Regulation

MDR and IVDR: Navigating the rocky road

Perfectly viable medical devices disappearing from the European market, manufacturers walking away from the EU rather than navigating regulatory demands, patients losing access to products with long,…

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News • Between AI law and patient reality

Do patients have a right to understand health AI?

"Why did the computer conclude this?": Patients increasingly scrutinize the impact of AI on medical diagnostics. A new article explores the tension between transparency and legal frameworks.

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News • Virtual companions, real responsibility

AI chatbots for mental health: experts call for clear regulation

Facing a mental health crisis, more and more people turn to chatbots and AI characters. While they offer new possibilities, they also pose great risks, especially for vulnerable users, experts warn.

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News • Pharmaceutical counterfeiting

New chemical approach to combat illegal medicines

Pharmaceutical counterfeiting remains a critical issue, with high risks for patients and great economical damage. Now, researchers propose using “chemical fingerprints” to identify illegal meds.

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News • Commentary on obesity treatments

Medical tourism for weight reduction surgery: Experts urge for regulation

Saving money, at a cost: To undergo bariatric and weight reduction surgery, more and more patients turn to institutions outside their home country – potentially putting their health at risk.

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Article • A hard farewell from the lead apron

Radiation protection: Were we wrong all along?

For more than a year now, patients in Austria are no longer required to wear a lead apron during radiological imaging procedures such as X-ray and CT scans. However, the new recommendation, issued by the country's five specialist societies for radiation protection and imaging, has sparked mixed reactions among radiology technologists. At the annual congress of the specialist society…

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Article • Sustainability

The challenge of "greening" medical technologies

Under the impulse of the European Commission, the in vitro diagnostic industry is developing emerging technologies to implement sustainable practices in medical laboratories. As sustainability has been a growing priority of the European Union (EU) in the last decade, ‘the medical technology sector, particularly the IVD sector, must comply with European legislation in this field like all other…

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Article • How to bring about better patient outcomes with health data

Propelling innovation in healthcare with the help of health data spaces

January 28 saw the celebration of the “Data Protection Day” as it is called in Europe, or respectively the “Privacy Day” as it is referred to outside of Europe. It marks the date on which the Council of Europe’s data protection convention, known as “Convention 108” was opened for signature back in 1981. According to the Council of Europe, it is the ‘only international,…

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