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THE TAPE

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 Diagnostics & IVD

BridgeSource Medical

Austin, TX · Bootstrapped · De Novo granted

Builds SmartRead, a handheld unit that identifies the manufacturer of a patient's implanted pacemaker or defibrillator in the emergency department. Also develops hemodynamic measurement and aerosol drug delivery devices under NIH small business awards.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Sep 29, 26	DEN260007510(k)	SmartRead(TM) Medical Device Identifier (4100)	BridgeSource Medical Corporation	Cardiovascular	SJJ

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BridgeSource Medical

FDA DECISIONS ON FILE

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