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…
LLM-based generative chat tools such as ChatGPT or Google’s MedPaLM have great medical potential, but there are inherent risks associated with their unregulated use in healthcare.
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,…
Current EU regulation does not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains, a recent study from Finland concludes.
New advanced therapies can alleviate or cure chronic diseases. But medical progress, such as the gene editing tool CRISPR, raises the question of how rights should be protected and balanced.
Medical imaging and healthcare IT company Esaote reports that it has completed the transition of its medical devices to comply with the new Medical Device Regulation (MDR).
New changes made to the timetable for the In vitro Diagnostic Medical Device Regulation (IVDR) across Europe could have a significant impact on manufacturers and users, an expert points out. While the extension of the transition period was a welcome step, other changes which were hoped for remain painfully absent.
The in vitro diagnostic regulation (IVDR) aims to make tests safer, more reliable, and sustainable. Unfortunately, it is also widely regarded a bureaucratic nightmare. At the ECCMID Day on Diagnostics, an expert proposed a more constructive approach.
Despite a five-year transition period for In-vitro Diagnostic Medical Device Regulation (IVDR), experts fear many actors in the field are still not prepared for the regulations coming into force.
In May 2022 a shortage of several lab tests may come as many manufacturers struggle to comply with EU regulation requirements covering in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746). Even modified tests and laboratory-developed tests will present a problem for hospitals and labs as explained by Dr Thomas Streichert.
With interoperability stalled, stakeholders are seeking new ways to create an interoperable ecosystem. IT specialist Jason Steen describes the state of interoperability in Australia and calls for more governmental commitment and international standards.
The pandemic has put a spotlight on the increasing role of cyberattacks and weaknesses in healthcare. In healthcare as in other industries, cybercrime does not stop at national borders. With this idea in mind, the US consulate general in Düsseldorf and the US embassy in Vienna recently invited interested parties to their Cybersecurity in Healthcare Briefing.
Since 2015, the number of known ransomware attacks has not only increased substantially across many industries. Hospitals, and the healthcare industry in general, have also become favorite targets of ransomware attackers, leading to very real incidents in which patient care and patients’ lives have been put at risk.
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.
