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EU Regulatory Roundup, June 2023: Medtech Shifts Focus To AI, Data And Digital

 
• By Eliza Slawther

The European Commission’s proposed AI Act entered high-level negotiations this month, generating a renewed interest among medtech stakeholders in this upcoming legislation and its impact on the sector.

Top Stories EU

On 14 June, the European Parliament adopted a draft mandate on the proposed Artificial Intelligence (AI) Act that will form the basis of its negotiations with the European Council and European Commission, known as trilogue discussions. The end result of these negotiations, which could conclude by spring 2024, will be a finalized version of the much-debated cross-sectoral regulation.

This news in itself was one of the top 10 most read articles among Medtech Insight subscribers in June,...

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More from Europe

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.

European MedTech Keeps Calm Despite US Threats Of 30% Tariffs

 
• By Amanda Maxwell

MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.

More from Geography

‘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.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
• By Brian Bossetta

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
• By Elizabeth Orr

US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the