BodyGuardian Remote Monitoring System (BGRMS v3.0) is an AI-enabled medical device from Boston Scientific Cardiac Diagnostic Technologies, Inc. that the U.S. FDA cleared through 510(k) K243349 on January 23, 2026. Its lead review panel is Cardiovascular and its primary product code is DSI (Detector And Alarm, Arrhythmia).
See also FDA-cleared AI cardiovascular devices in 2026, all FDA AI clearances in 2026, top cardiovascular AI devices.
Key facts
| Submission number | K243349 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Boston Scientific Cardiac Diagnostic Technologies, Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | DSI — Detector And Alarm, Arrhythmia |
| Applicant (openFDA) | Boston Scientific Cardiac Diagnostic Technologies, Inc. |
| Applicant location | Rochester, MN, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.1025 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. BodyGuardian Remote Monitoring System (BGRMS v3.0) went through this pathway (K243349).
openFDA lists it as a Class 2 device under 21 CFR 870.1025. Class II devices are moderate risk and are subject to general and special controls.
Product code DSI covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Boston Scientific Cardiac Diagnostic Technologies, Inc. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.