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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 / Imaging & Radiology

Imaging & Radiology Cardiovascular Digital Health & SaMD

Bunkerhill Health

San Francisco, CA · Series B · 510(k) cleared

Bunkerhill Health develops FDA-cleared AI algorithms that find cardiovascular and bone disease on imaging and ECGs ordered for other reasons. Hospitals run them through its Carebricks platform.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Mar 6, 26	K260166510(k)	Bunkerhill Contrast CAC	BunkerHill Health	Radiology	JAK
Mar 6, 26	K260167510(k)	Bunkerhill Contrast AVC	BunkerHill Health	Radiology	JAK

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Bunkerhill Health

FDA DECISIONS ON FILE

COVERAGE