News We’re Watching: Potential Shockwave Sale, Medtronic Layoffs, Warning Letter For Abbott

This week, the US FDA announced the Class I recall of Fresenisu Kabi’s Ivenix Infusion System. Also: Successful trial results from Boston Scientific, Ancora partners with Egnite, and trade groups object to the Environmental Protective Agency’s proposed rules on ethylene oxide.

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• Source: Medtech Insight

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More from Medtech Insight

THENA Capital ‘Makes History’ As UK’s First All-Female Early-Stage Medtech Fund

 

Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."

Government Pulls ‘For Sale’ Signs From US FDA’s White Oak Campus

 
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The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.

AI-Based Screening Tool For Musculoskeletal Issues Gets US FDA Warning Letter

 
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Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.