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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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: K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261488 (OBSIDIO Conformable Embolic), K262165 (FARADRIVE Steerable Sheath (M004PF21M402)), K262462 (TheraSphere 360 Y-90 Management Platform).

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