The U.S. Food and Drug Administration (FDA) cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or therapeutic procedures; and monitoring the effectiveness of certain therapies,” said…
The FDA approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions.
Thousands of unvaccinated French health workers face suspension without pay under a new COVID-19 law that punishes people in care professions who refuse to get immunised against the virus.
MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran an industry survey, which shows an urgent, high risk to the availability of IVD medical tests once the new IVD Regulation fully applies.
Agfa HealthCare is proud to be one of the first companies to receive the new European Medical Device Regulation (MDR) certification, which was issued by Intertek on 25 August 2021. This certification, which covers Agfa HealthCare’s Class IIa Enterprise Imaging and Xero Viewer solutions, ensures that Agfa HealthCare can continue to deliver to customers innovative solutions that meet their real…
Brexit could have a potential impact on healthcare delivery across the UK, according to an expert in the field. Dr Hugh Harvey believes that will be particularly noticeable in the area of Medical Device Regulation (MDR), with the UK and Europe seemingly going in different directions on the subject after the UK left the European Union (EU) at the end of last year.
A new paper co-written by a University of Illinois Urbana-Champaign scholar who studies the legal and ethical implications of advanced biotechnologies outlines an unexplored tool to regulate the medically and ethically dubious practice of heritable human-genome editing: patent law.
The EU’s General Data Protection Regulation (GDPR) has created a great deal of uncertainty about how key requirements should be interpreted. This means that collaborators in international genetic research projects do not always agree on fundamental issues such as whether they are processing personal data, consent requirements under the GDPR and on what basis genetic data can be transferred…
With new Medical Device Regulations (MDR) now in force across Europe, the UK has chosen to retain pre-existing rules while also introducing mechanisms to allow it to draw up separate rulings for the sector in the future. The MDR took effect on May 26, aiming to harmonise and strengthen the pre-existing regulatory regime for medical devices, and enhance protection for consumers.
26 May 2021 marks the Date of Application of the European Medical Device Regulation (MDR). Replacing the Medical Devices and Active Implantable Medical Devices Directives, the Regulation is a welcome update for patient safety, transparency, and access to medical devices for Europeans. COCIR has been contributing to the development and implementation of the MDR since the very first discussions in…
New regulations covering medical devices are set to come into effect across Europe. Originally intended to be implemented in May 2020, the introduction of the updated Medical Device Regulation (MDR) was delayed because of the coronavirus pandemic. The new regulations – the first major update in three decades – now come into force on May 26, and to mark the date a special conference discussed…
In Sweden, there are over 2 million legally owned firearms. At the same time, up to 150,000 people live with a diagnosis of dementia. In an aging society such as Sweden, legislators will face challenges in gun ownership. A new registry-based observational study by researchers from NVS, Karolinska Institutet, published in the Journal of Alzheimer’s Disease shows a need for strategies for this…
Advice on the application of the Medicrime Convention in the context of counterfeit COVID-19 vaccines.
In just the last two years, artificial intelligence has become embedded in scores of medical devices that offer advice to ER doctors, cardiologists, oncologists, and countless other health care providers. But how much do either regulators or doctors really know about the accuracy of these tools? A new study led by researchers at Stanford, some of whom are themselves developing devices, suggests…
Covid-19 vaccine passports could be created, but significant challenges need to be overcome first, according to a report from a panel led by Oxford Professors Melinda Mills and Chris Dye, which outlines a dozen issues which must be addressed before passports can be introduced. The report is published by the SET-C (Science in Emergencies Tasking: Covid-19) group at the Royal Society and it…
There’s a 7-fold unexplained variation in rates of euthanasia across The Netherlands, reveals an analysis of health insurance claims data. It’s not clear if these differences relate to underuse, overuse, or even misuse, say the researchers. The Netherlands was the first country in the world to legalise euthanasia and physician-assisted suicide, introducing preliminary legislation in 1994,…
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.
