Sept. 18, 2025
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NOTE FROM THE EDITOR
In MedTech Dive’s latest coverage of artificial intelligence in medical devices, we dig into a buzzword that medtech firms have started using in recent years. More companies are talking about “foundation models,” a type of AI tool that is built on a large dataset and can tackle a variety of tasks. Companies are starting to develop foundation models in imaging and radiology, despite an uncertain regulatory path.
For our two-part series, read more about how foundation models work and what types of tools companies are building.
As always, thanks for reading,
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AdvaMed welcomed the committee’s work on the legislation but called for the inclusion of diagnostics in the bill.
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UPDATED
Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.
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J&J’s Shockwave Javelin intravascular lithotripsy catheter treats people with peripheral artery disease. Elsewhere, Medtronic began a pivotal trial to evaluate its pacemakers in a new patient group.
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Device manufacturers face growing pressure to deliver wearables that meet user demands for extended wear times while ensuring comfort, safety, and reliable performance. Learn how to ensure market success in
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The companies will develop a robotic system to improve patient outcomes in complex hemorrhagic cases and time-sensitive ischemic strokes.
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BD, which has not received any complaints related to the issue, previously discontinued the devices affected by the expanded recall.
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