Cardiology
Acumen Hypotension Prediction Index (HPI) Feature Software
Edwards Lifesciences LLC
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. 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
- DEN160044
- Decision date
- March 2018
- FDA panel
- Cardiovascular
- Product code
- QAQ
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.