The MHRA is working to update the national software and AI rules as a medical device, as part of its new freedoms in Brexit, without any obligation for adopting the EU Member States’ regulatory methods “These measures demonstrate the U.K.’s commitment, following our exit from the European Union, to drive innovation in healthcare and improve … Continued
Due to its wide definition and misalignment with current legal frameworks, MedTech Europe has insisted on immediate clarification on a draft artificial intelligence (AI) policy from the EU Earlier this year, the European Commission revealed its proposals to regulate AI, including medical devices and in-vitro diagnostics that use it. To be eligible for EU approval, … Continued
Switzerland will no longer have free access to the EU single market due to failure of adapting to Medical Device Regulation After enjoying free trade access to the EU market through bilateral agreements since 2002, failed negotiations on the new Medical Device Regulations (MDR) have seen Switzerland drop out without a deal this week. The … Continued
Ransomware attacks have struck hospitals in New Zealand, disrupting their IT systems, highlighting the importance of confidentiality in healthcare Words by Dr. Ryan Grech and Dr. Dylan Attard, Clinical & Health Tech Advisors for MedTech World and two of the co-founders of Digital Health Malta. We won’t pretend that we’re cybersecurity experts because we are not … Continued
After three years of review, revise and reintroduction, the EU Health Technology Assessment dossier is reaching the final stage of negotiations Interinstitutional negotiations on the implementation of unified Health Tech Assessment have begun. The legislative initiative seeks to unify the assessment of effectiveness and value of new medical tech, including pricing and compensation by health … Continued
One Drop’s AI-backed blood glucose forecasting tool securing a CE mark is a pivotal regulatory milestone One Drop has received the CE mark for its blood glucose prediction analysis engine which employs artificial intelligence (AI) to forecast glucose levels accurately. The tool is targeted at people living with prediabetes, type 2 diabetes, and gestational diabetes. … Continued
At-home testing. Another part of the puzzle, but regulators need to step up their game. Words by Dr. Ryan Grech and Dr. Dylan Attard, Clinical & Health Tech Advisors for MedTech World and two of the co-founders of Digital Health Malta. In the previous article, Dr. Ryan Grech and Dr. Dylan Attard discussed the 5 levels … Continued
Biobeat and its AI-backed wearable remote patient monitoring platform secures CE mark Biobeat’s AI-based at-home wearable patient monitoring platform has received CE mark. The approval includes the firms wrist and chest-patch monitoring devices’ which tracks the patient’s vital signals such as respiratory rate, mean arterial pressure, pulse pressure, stroke volume, cardiac output, cardiac index, blood … Continued
Cerus Endovascular’s application for Contour System study to treat intracranial aneurysms approved by the FDA Cerus Endovascular’s investigational device exemption (IDE) application receives approval from the US Food and Drug Administration (FDA) to go ahead with a trail of its Contour Neurovascular System in the US. The system has been developed for treating intracranial aneurysms, … Continued
Seigla Medical obtained CE mark for its LiquID Guide Catheter Extension, used during coronary and peripheral vasculature interventions US-based startup medical device company, Seigla Medical, have received CE mark for its guide catheter extnesion used during coronary and peripheral vasculature interventions. According to Seigla, guide catheter extensions are used annually in over 500,000 interventional procedures … Continued
