June 18, 2018
FDA Clears Sensydia’s Cardiac Performance System
The Sensydia Cardiac Performance System (CPS ) is the first patient-worn system to provide Ejection Fraction information to clinicians for evaluation of cardiac function for diagnosis and management of heart disease and abnormal heart function.
Los Angeles CA—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.
CPS has been proven in clinical trials to be equivalent in accuracy to echocardiography measurement of cardiac ejection fraction. “The development of CPS is a result of a multi-disciplinary medical and engineering approach to solving the most critical problems facing healthcare—heart diseases including heart failure,” said Aman Mahajan MD, Sensydia’s Chief Medical Officer. “We have developed a patient-centered solution that provides a convenient assessment capability for measuring cardiac ejection fraction in patients anywhere, with no operator technical challenges nor errors related to operator interpretation. Our clinical trials confirm that we can deliver a low cost, easy to use solution that delivers precise and reliable results.”
Integrating CPS into patient care also addresses three critical issues in healthcare today: the transition to patient-centered treatment; risk management in healthcare delivery; and the trend from centralized hospitals to networks including satellite clinics. “CPS generates data that can be easily used to manage cardiac risk in the healthcare delivery system,” said Tom Bruggere, CEO. “In addition, CPS is perfect for the emerging trend in healthcare delivery from centralized hospitals to networks including satellite clinics—this low cost, patient worn, and easy to use system does not require large investments in capital or training.”
CPS sensing and analytics technology is immediately available to enhance and to integrate with current patient care monitor systems. “CPS relies on a series of unprecedented breakthroughs based on cardiac physiology principles and exploiting fundamental sensing and analytics technology advances. CPS is immediately available to enhance standard patient care technology everywhere” said William Kaiser, PhD, Chief Technology Officer. “We designed CPS for immediate application in patient assessment in accordance with healthcare best practices.”
“Colle Capital backed and actively support a team with an incredible vision and deep domain expertise. We are thrilled with the progress Sensydia has made and excited for the future product roadmap. What excites me the most is the reach of this technology beyond immediate applications. I envision this approach to extend beyond patient evaluation for heart function, with future applications to provide comprehensive diagnostic and monitoring capabilities for heart health. It can potentially save an enormous number of lives and significantly reduce overall cost associated with cardiac care,” said Victoria Grace, founder of Colle Capital and Board member of Sensydia.
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