Sensydia

Sensydia is a medical technology company that has developed the Cardiac Performance System (CPS), a non-invasive cardiac monitoring device that measures critical heart performance metrics. The CPS utilizes ultra-sensitive biosensors to acquire heart sound data and applies machine learning algorithms to compute hemodynamic measurements such as ejection fraction, cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure. The device delivers these comprehensive measurements in a single report via an iPad app.

The CPS technology aims to revolutionize the diagnosis and management of heart failure and pulmonary hypertension by providing accurate and rapid assessments without the need for invasive procedures like cardiac catheterization or echocardiography. The device received FDA 510(k) clearance for non-invasive ejection fraction measurement in 2018 and was granted Breakthrough Device Designation by the FDA in January 2022 for the additional cardiac metrics.

Sensydia has conducted multiple successful clinical studies across various institutions, including the University of Minnesota, University of Pittsburgh Medical Center, and Ronald Reagan UCLA Medical Center, to validate and refine the CPS algorithms. The company raised approximately USD 8 million in funding in May 2023 to prepare for the commercialization of the CPS platform and plans to submit it for prioritized FDA review in 2024 under the Breakthrough Devices Program.

In June 2023, Sensydia secured a USD 3 million grant from the National Institutes of Health (NIH) for the development and clinical testing of the machine learning algorithms for the CPS, further validating the potential of the technology to improve cardiac care.