FDA Clears Sensydia’s Cardiac Performance System


The Food and Drug Administration (FDA) has cleared Sensydia Corporation’s revolutionary Cardiac Performance System (CPS™), a non-invasive, patient-worn, device for automated measurement of Ejection Fraction. Sensydia has developed CPS to solve an unmet need for convenient and accurate direct measurement of cardiac Ejection Fraction, which is a primary factor in diagnosis and management of patients with heart disease and abnormal heart function. CPS is a non-invasive, patient-worn device that allows clinicians to measure and analyze Ejection Fraction without operator interpretation to provide fast information about heart health. 

The Sensydia CPS was developed through a combination of cardiac physiology insight, extensive clinical trials, and the introduction of novel machine learning methods for development of device analytics. CPS provides validated Ejection Fraction measurements using a new, low cost sensing technology that incorporates disposable sensors and signal processing algorithms.

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