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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 / January 2026 / K243349

510(k) cleared

BodyGuardian Remote Monitoring System (BGRMS v3.0)

Boston Scientific Cardiac Diagnostic Technologies, Inc. · Jan 23, 2026 · K243349

FDA cleared the BodyGuardian Remote Monitoring System (BGRMS v3.0) from Boston Scientific Cardiac Diagnostic Technologies, Inc. on Jan 23, 2026 under K243349, a traditional 510(k). The device falls under product code DSI, Detector And Alarm, Arrhythmia, regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Oct 28, 2024. The decision came 452 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Boston Scientific Cardiac Diagnostic Technologies, Inc. has 8 other decisions in the tracker over the last 12 months: K262151 (SpaceOAR Flex System), K262460 (Rezum System), K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K253692 (AVVIGO+ Multi-Modality Guidance System).

Questions & Answers

What did FDA clear under K243349?

K243349 is the FDA 510(k) for BodyGuardian Remote Monitoring System (BGRMS v3.0), submitted by Boston Scientific Cardiac Diagnostic Technologies, Inc.. FDA's decision date was Jan 23, 2026, under product code DSI (Detector And Alarm, Arrhythmia).

Who makes the BodyGuardian Remote Monitoring System (BGRMS v3.0)?

Boston Scientific Cardiac Diagnostic Technologies, Inc., based in Rochester, MN, is the applicant of record for K243349.

How long did the K243349 review take?

FDA received the submission on Oct 28, 2024 and issued its decision on Jan 23, 2026, 452 days later.

← All decisions in January 2026