1. Medtech Insight
  2. >>Geography
  3. >>Europe

MedTech Europe Calls For Swift Answers In Areas Where AI Act Threatens MedTech

 
• By Amanda Maxwell

With the EU AI Act close to being finally adopted, industry is now calling for guidance and clarification to prevent the new legal text complicating the regulation of medical devices and diagnostics and putting obstacles in the way of patient access to innovation.

"Uncertainty Ahead” sign on a background of blue sky with clouds

With the imminent final adoption of the EU’s AI Act, EU industry association, MedTech Europe, has published a series of recommendations to ensure “a clear and practical applicability” of the new ruling to the medical technology sector.

The key proposals set out in its paper, Medical technology industry perspective on the final AI Act, are as...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

A Passport To Streamlined Medtech Access Under UK Life Sciences Plan

 
• By Ashley Yeo

An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.

EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 
• By Amanda Maxwell

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

‘Eyes – A Window Into The Heart’: Retinal AI Tool Predicts Future Risk Of Heart Attack And Stroke

 
• By Natasha Barrow

A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.

PFA Market Surges As UK NICE Opens Doors And US FDA Approves Boston, J&J Incremental Innovations

 
• By Natasha Barrow

The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.

More from Geography

Experts Call For Database Of Medical Device Labels

 
• By Elizabeth Orr

A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.

EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 
• By Amanda Maxwell

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

‘Eyes – A Window Into The Heart’: Retinal AI Tool Predicts Future Risk Of Heart Attack And Stroke

 
• By Natasha Barrow

A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.