Cardiology
CLEWICU System (ClewICUServer and ClewICUnitor)
CLEW Medical Ltd.
The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
FDA Submission Metadata
- Submission number
- K200717
- Decision date
- January 2021
- FDA panel
- Cardiovascular
- Product code
- QNL
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.