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AI & Regulation: AdvaMed Aims To Mold Artificial Intelligence Policy For Device Industry

 
• By Shawn M. Schmitt

As AI becomes more prevalent in the medical device arena, thought-leaders in industry and US FDA are looking down the road at how artificial intelligence can be regulated in a way that doesn't stymie innovation. AdvaMed is helping to lead the charge by crafting policy points to address the issue.

Elon Musk has grave concerns about artificial intelligence.

"It is difficult to appreciate just how far artificial intelligence has advanced, and how far it is advancing," the CEO of Tesla Motors and SpaceX said at the

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The Value Of Consumer Wearables Within The Clinic Is Currently Unknown, Says Cardiologist

 
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“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
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The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.

Peerbridge Bets On At-Home Heart Monitoring With Rechargeable, Longer-Lasting ECG Patch

 
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Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
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Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

More from Digital Technologies

Dexcom Puts Stelo On Amazon, Setting Up Consumer Showdown With Abbott

 
• By Shubham Singh

In addition to broader distribution, Dexcom is investing heavily in software enhancements for Stelo. The 180-day data lookback feature is just one of several planned upgrades intended to improve personalization and user engagement.

Subsense Develops Nonsurgical, Nanoparticle-Based Brain-Computer Interface For Neurological Disorders

 
• By Marion Webb

Neurotechnology start-up Subsense came out of stealth with $17m in seed funding to develop a nonsurgical, nanoparticle-based brain-computer interface. Medtech Insight spoke with the firm’s new neurotech lead Cyril Eleftheriou about the technology and its potentially wide applications for treating Parkinson’s, epilepsy, inner speech decoding, and more.

AAOS 2025 Orthopedic Roundup: J&J Velys UKA, Stryker Mako 4, Materialise, Canary Medical

 
• By Marion Webb

At AAOS, orthopedics players showcased their latest robotic-assisted platforms, power tools, 3D printed technologies and software offerings. This article brings you highlights from interviews Medtech Insight conducted on site with representatives from J&J, Stryker, Materialise and Canary Medical.