Sensydia

Sensydia has developed the Cardiac Performance System™ (CPS), a non-invasive diagnostic device that rapidly measures key cardiac performance metrics such as ejection fraction, cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure. The CPS leverages ultra-sensitive biosensors and proprietary machine learning algorithms to provide results comparable to gold-standard invasive procedures but without the need for catheterization. The system received FDA clearance in 2018 for non-invasive ejection fraction measurement and was granted Breakthrough Device Designation by the FDA in January 2022. As of April–June 2025, CPS is undergoing pivotal multi-center clinical trials comparing its accuracy to right heart catheterization to support broader regulatory approval. Early data presented at ACC25 demonstrated accurate non-invasive mean pulmonary artery pressure assessment.