Sensydia wins FDA breakthrough nod to expand uses for its cardiac monitoring device

[Image from Sensydia]Sensydia announced today that it received FDA breakthrough device designation for its Cardiac Performance System (CPS).

Los Angeles-based Sensydia designed CPS as a non-invasive cardiac monitoring device that reports critical heart performance measurements to physicians for the comprehensive evaluation of patients with advanced and persistent heart failure. It can make the measurements without an in-hospital catheterization procedure or ultrasound assessment, according to the company

CPS already has FDA clearance for measuring ejection fraction — and can presently measure cardiac output, pulmonary artery pressure and pulmonary capillary wedge pressure simultaneously.

According to a news release, CPS uses ultra-sensitive biosensors to acquire heart sound data before applying machine learning to compute multiple hemodynamic measurements. The platform then delivers a comprehensive all-in-one report through its CPS iPad application.

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