Cardiology
Biovitals Analytics Engine
Biofourmis Singapore Pte. Ltd
FDA
FDA-cleared AI medical device
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
FDA Submission Metadata
- Submission number
- K183282
- Decision date
- August 2019
- FDA panel
- Cardiovascular
- Product code
- PLB
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Signals
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.
Regulatory Approvals
FDA
US FDA 510k
K183282
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.