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.
“Sensydia’s acoustic sensing technology and advanced AI algorithms form the basis of CPS, and together with our stellar research and development capabilities, position it as a breakthrough device,” Sensydia President & CEO Anthony Arnold said in the release. “This breakthrough designation is a significant milestone for Sensydia. We look forward to working with the FDA to advance the development of CPS and bring it to market in 2023.”