Sam Brusco, Associate Editor01.19.22
Sensydia, developer of rapid, non-invasive cardiac function measurement tech, earned breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its Cardiac Performance System (CPS).
CPS reports critical heart performance metrics to physicians to evaluate advanced and persistent heart failure patients without requiring a catheterization procedure or ultrasound exam.
The device’s biosensors acquire sound data and it applies machine learning to compute multiple hemodynamic measurements. CPS then send a comprehensive report via an iPad app. It can currently simultaneously measure ejection fraction (already FDA cleared), cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure.
“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,” Anthony Arnold, president and CEO of Sensydia told the press. “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.”
“The approach taken by the Sensydia team towards cardiac care is impressive and second to none,” added Victoria Grace, Founder of Colle Capital and Sensydia Board Member. “We believe this special FDA designation will accelerate our ability to bring this transformational device to market and make a positive impact on the lives of patients.”
CPS reports critical heart performance metrics to physicians to evaluate advanced and persistent heart failure patients without requiring a catheterization procedure or ultrasound exam.
The device’s biosensors acquire sound data and it applies machine learning to compute multiple hemodynamic measurements. CPS then send a comprehensive report via an iPad app. It can currently simultaneously measure ejection fraction (already FDA cleared), cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure.
“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,” Anthony Arnold, president and CEO of Sensydia told the press. “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.”
“The approach taken by the Sensydia team towards cardiac care is impressive and second to none,” added Victoria Grace, Founder of Colle Capital and Sensydia Board Member. “We believe this special FDA designation will accelerate our ability to bring this transformational device to market and make a positive impact on the lives of patients.”