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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 Tracker / September 2026 / DEN260007

510(k) cleared

SmartRead(TM) Medical Device Identifier (4100)

BridgeSource Medical Corporation · Sep 29, 2026 · DEN260007 · In the directory

FDA cleared the SmartRead(TM) Medical Device Identifier (4100) from BridgeSource Medical Corporation on Sep 29, 2026 under DEN260007, a direct 510(k). The device falls under product code SJJ, Cardiac Device Identifier, regulated at 21 CFR 870.3645 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 24, 2026. The decision came 189 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for BridgeSource Medical Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN260007?

DEN260007 is the FDA 510(k) for SmartRead(TM) Medical Device Identifier (4100), submitted by BridgeSource Medical Corporation. FDA's decision date was Sep 29, 2026, under product code SJJ (Cardiac Device Identifier).

Who makes the SmartRead(TM) Medical Device Identifier (4100)?

BridgeSource Medical Corporation, based in Austin, TX, is the applicant of record for DEN260007. The company is listed in the MedDevice Startups directory.

How long did the DEN260007 review take?

FDA received the submission on Mar 24, 2026 and issued its decision on Sep 29, 2026, 189 days later.

← All decisions in September 2026