Cardiology
BodyGuardian Remote Monitoring System (BGRMS v3.0)
Boston Scientific Cardiac Diagnostic Technologies, Inc.
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K243349
- Decision date
- January 2026
- FDA panel
- Cardiovascular
- Product code
- DSI
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.