Cardiology
Gili Pro BioSensor (also known as Gili BioSensor System)
ContinUse Biometrics Ltd.
FDA-cleared AI medical device
The device uses an optical sensor system and software algorithms to obtain and 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
- DEN200038
- Decision date
- April 2021
- FDA panel
- Cardiovascular
- Product code
- QOK
- 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.