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Edwards Lifesciences Corporation has shared new one-year data on the safety and effectiveness of its Evoque transcatheter tricuspid valve replacement (TTVR) system among patients with tricuspid regurgitation (TR)

CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.

Bard Peripheral Vascular Rotarex Atherectomy System recall

The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

agentic AI agents in healthcare

Healthcare AI agents can be classified as one of four models. In increasing order of autonomy and clinical integration, these are: foundation, assistant, partner and pioneer. 

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The notices are unrelated, but both require that clinicians adhere to a set of updated use instructions. One patient died as a result of injury. 

Motivity is receiving an injection of cash from Five Elms Capital, a software investment firm. The companies said the funds will be used to hire staff and improve products.  

There have been two reported injuries linked to the Smiths Medical ProPort Plastic Implantable Ports, many of which are subject to an immediate recall. 

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One product is being pulled from the market, and the other is receiving updated instructions for use.

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology? 

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology.