The U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,”…
Health industry sectors, representing pharmaceutical and medical technology companies (COCIR, EFPIA, EuropaBio, MedTech Europe and Vaccines Europe) welcome the publication of the European Partnership for Innovative Health Proposal as a significant milestone towards a European Partnership for Health Innovation. The future partnership will showcase to researchers, patients, and citizens that Europe…
On May, 29th 2020, European Hospital published a press release from the Plasma Protein Therapeutics Association (PPTA). In that release, the PPTA expressed their concerns about the recommendations contained in the 20th version of Blood Guide of The European Directorate for the Quality of Medicines and Healthcare (EDQM). Read here the EDQM’s rebuttal letter to the PPTA.
Austria-based cochlear and hearing implants technology company Med-El has become one of the first manufacturers worldwide, and the first and only hearing implant manufacturer in the world, to be granted European Medical Device Regulation (MDR) certification. The company made an initial announcement on the newly earned certification after making an early commitment to adopt the MDR in 2016. For…
The Plasma Protein Therapeutics Association (PPTA) is concerned about the recommendations contained in 20th version of Blood Guide of The European Directorate for the Quality of Medicines (EDQM) which aims to harmonise standards and recommendations on blood collection, preparation, and the use of blood and blood components. This Guide, if applied, will have a negative impact on the availability…
The intentions behind the Medical Device Regulation (MDR) are good. Ultimately, the regulations should prevent inferior medical devices, technologies and pharmaceuticals from endangering peoples’ lives while increasing the quality of drugs and devices entering the market. At the same time, MDR could present several serious immediate challenges to European healthcare systems.
The coronavirus last week reached the Netherlands and began to spread around the country. How has the Dutch population reacted? What is a useful frame of reference for this situation? And what are the legal guidelines for dealing with the outbreak? Four researchers from the University of Amsterdam – a clinical microbiologist, an anthropologist, a social scientist and a health lawyer – explain…
Artificial intelligence (AI) opens up a host of new diagnostic methods and treatments. Almost daily we read about physicians, researchers or companies that are developing an AI system to identify malignant lesions or dangerous cardiac patterns, or that can personalise healthcare. ‘Currently, we are too focused on the topic,’ observes Professor Christian Johner, of the Johner Institute for…
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa…
The U.S. Food and Drug Administration (FDA) announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care. For the first time in more than 20 years of regulating mammography facilities, the agency is proposing amendments to key regulations that would help improve…
COCIR, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, published an open letter to the European Commission & National Competent Authorities for Medical Devices.
Half of clinical trials on the EU register have not reported results, despite rules requiring results to be posted within 12 months of completion, finds a study published by The BMJ. Findings show compliance has been poor overall, but companies show higher rates of compliance than academics
The fact that genetic research can reveal hereditary diseases has been transferred to medical practice for some time and, since 2010, the Gene Diagnostics Act (GenDG) has regulated permissible DNA tests in medical diagnostics and pedigree in Germany. The procedure has great potential, says Professor Jochen Taupitz - but also great risks are associated with it.
The U.S. Food and Drug Administration approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye. The iris is made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual…
The radiographer in Switzerland faces many issues, from having the right education to positioning themselves both professionally and legally in the healthcare continuum. Before a large audience at ECR 2018, Yves Jaermann, head of the radiographers service Riviera-Chablais Hospital in Vaud Valay, reviewed the situation in his country. The profession of radiographer was born in 1896, when the first…
New laws mark the biggest shake-up in data protection legislation in decades. The General Data Protection Regulation (GDPR) comes into effect across Europe on May 25. Whilst the new legislation affects a wide range of organisations and businesses, Freelance Data Privacy Consultant Darren Rose emphasises the importance of healthcare providers being ready for the change.
An Italian law requiring citizens to hold a certificate to use a defibrillator must change to improve survival from cardiac arrest, researchers argued today at Acute Cardiovascular Care 2018, a European Society of Cardiology congress. “Automated external defibrillator (AED) use before the arrival of the emergency medical services (EMS) plays a key role in improving victim survival from…
With the European Union regulation on medical packaging coming into effect February 2019, Track & Trace technology and serialisation have become a key topic in the medical packaging industry. Work processes must now allow for the authentication of products with individual serial numbers printed on each or its packaging, a process called serialisation. The industry is adapting to the new…
By 2020 medical devices manufacturers must document the clinical effectiveness of their devices more extensively. The Medical Device Regulation (MDR) presents a fundamental impact on innovation and price calculation for medical devices. Since the faulty PIP breast implants scandal in France (March 2010), there have been frequent calls for tighter licensing regulations for medical devices within…
Manufacturers are required to prevent so-called anomalous use. This includes, for instance, the use of cuvettes that are not licensed in products like Teco’s Coatron-X. Norms and directives are the backbone of medical devices manufacture. Frequent updates keep them current, but also often create unforeseen problems, especially for smaller and medium-size companies, because the bureaucracy is…
Radiographers are increasingly central to patient care, but the heterogeneous education and skills across Europe remain challenging. Dr Jonathan McNulty and Håkon Hjemly, of the European Federation of Radiographers Societies (EFRS), explained how they plan to improve radiographers’ visibility and work towards homogenising training across Europe, notably by launching a European Diploma in…
It is of grave concern that there has been no public consultation on government plans to enable accountable care organisations (ACOs) to operate in England, say experts in The BMJ. ACOs were conceived in the US in an effort to improve care and reduce growing health care costs. They involve government and private insurers awarding large contracts to commercial providers to run and provide…
Whilst Spain has announced a new record for organ donations the number in Germany is stabilising at a ‘low level’. The good news? The number did not fall any further following scandals surrounding the manipulation in the allocation of donor organs.
British NHS organisations are obliged by law to report people it fears at risk of becoming terrorists under the Prevent strategy - part of the UK government’s counterterrorism plan aimed at stopping people becoming terrorists. But new data collected by The BMJ has uncovered low levels of referrals to Prevent since the duty took hold, suggesting that it is having little impact in the NHS.
Dutch healthcare is internationally viewed as high level. However, the cost of care continues to rise, despite all the cuts.
