The non-invasive system evaluates the mechanical efficiency and electrical activity of the heart
Inovise Medical has received the US Food and Drug Administration (FDA) Breakthrough Device designation for its AUDICOR heart failure management system.
The non-invasive remote monitoring system leverages clinically tested algorithms to detect the risk of decompensation at home, in patients previously hospitalised for heart failure.
Indiana University clinical professor Michael Mirro said: “This technology promises to enhance the management of heart failure patients and keep them out of the hospital.
“Early detection of potential problems outside of the hospital can allow clinicians to modify the patients’ therapeutic regimens and maintain their stable condition.”
The AUDICOR heart failure management system evaluates the mechanical efficiency, and electrical activity of the heart in a non-invasive manner, said the company.
The hand-held device of the system acquires the signals, and transfers them to the connected smart phone for analysis in the cloud.
The analysis of signals offers cardiac acoustic biomarkers, which would provide actionable data to optimise therapy and improve patient outcomes.
Also, the physicians will receive notifications based on biomarker trends and values, enabling them modify patient therapy eliminating deterioration of heart failure that may require hospitalisation.
Inovise Medical is engaged in deploying artificial intelligence (AI) and machine learning (ML) techniques, along with traditional algorithm development to address the problem of heart failure.
Inovise Medical CEO Peter Bauer said: “The most significant advantages of this new technology are enhanced ease of use, eliminated risks of surgical complications, and significantly reduced costs compared to permanently implanted physiologic sensors currently on the market.”