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EU Regulating AI ‘Like A Microwave’ When Focus Should Be Its Ability To Cook

 
• By Eliza Slawther

Concerns are mounting over how the EU’s AI Act will impact the medtech sector. Now, a computer science expert has argued that the proposed regulation is fundamentally flawed in its approach, because it puts the focus on the AI product instead of its output.

AI Doctor
• Source: Shutterstock

The European Commission’s proposal for a horizontal regulation that applies to all artificial intelligence (AI) products has been largely met with skepticism from stakeholders across the medtech industry. So far, much of this criticism has focused on the overlap between the AI Act and other regulations in the EU, such as the sector-specific Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR).

A wider perspective on the AI Act and its “fundamental problem” was offered by a philosopher and computer ethics professor during a recent webinar on digital health and AI, hosted

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FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

Tariff Pressures Creep Into Dexcom’s Margin Outlook Despite Domestic Manufacturing Shield

 
• By Shubham Singh

Dexcom’s relatively strong position amid tariff-related uncertainty is rooted in its long-standing investments in domestic manufacturing, but raw material inflation is driving cost concerns even in the face of operational efficiencies.

Does Makary’s Reorg Choice Mark FDA Turning Point?

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.