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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Directory / Cardiovascular

Cardiovascular

JenaValve Technology

Irvine, CA · Growth · PMA approved

Develops the Trilogy transcatheter heart valve, approved in the U.S. in 2026 for severe aortic regurgitation. Backed by Bain Capital Life Sciences, Andera Partners and Valiance.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Mar 17, 26	P250024PMA	Trilogy Transcatheter Heart Valve System	JenaValve Technology, Inc.	Cardiovascular	NPT

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JenaValve Technology

FDA DECISIONS ON FILE

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