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# Sensydia Breakthrough Status for Cardiac Biosensor Monitor
- URL: https://www.fdaweb.com/sensydia-breakthrough-status-for-cardiac-biosensor-monitor/
- Published: 2022-01-20T12:00:00.000Z
- Updated: 2026-09-14T17:29:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150970

FDA has granted Sensydia a breakthrough device designation for its Cardiac Performance System (CPS) that measures critical cardiac function. The cardiac monitoring device is designed to report critical heart performance measurements to physicians for comprehensive evaluation of patients with advanced and persistent heart failure, without requiring an in-hospital catheterization procedure or ultrasound assessment, according to the company.

Through its ultra-sensitive biosensors, CPS acquires heart sound data and applies machine learning to compute multiple hemodynamic measurements, delivering all in one comprehensive report to the CPS iPad app, Sensydia says. It measures ejection fraction, cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure simultaneously, it says.