BodyGuardian Remote Monitoring System (BGRMS v3.0) is an AI-enabled medical device from Boston Scientific Cardiac Diagnostic Technologies, Inc., listed by FDA (510(k), K243349) with a decision date of 2026-01-23. Review panel: Cardiovascular.
| FDA submission number | K243349 |
|---|---|
| Pathway | 510(k) |
| Company | Boston Scientific Cardiac Diagnostic Technologies, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2026-01-23 |
| Decision | Substantially Equivalent |
| Product code | DSI |
| Classification | Detector And Alarm, Arrhythmia |
| Device class | 2 |
| Regulation number | 870.1025 |
| Review time (calendar days) | 452 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.