Cardiology
FaceHeart Vitals Software Development Kit (FH vitals SDK)
FaceHeart Corp.
FDA-cleared AI medical device
The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
FDA Submission Metadata
- Submission number
- K223622
- Decision date
- September 2023
- FDA panel
- Cardiovascular
- Product code
- QME
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Images
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.