PORTLAND, Ore. – February 23, 2021 – (Newswire.com)
Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR® heart failure management system. The system uses clinically tested algorithms to detect the risk of decompensation at home in patients who have been previously hospitalized for heart failure.
Michael Mirro, MD, Director of the Parkview Mirro Center for Research and Innovation, and Clinical Professor of Medicine at Indiana University, commented, “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 is non-invasive and assesses the mechanical efficiency, as well as the electrical activity, of the heart. Signals are acquired through a hand-held device that connects to a smart phone for analysis in the cloud. This analysis of the signals produces proprietary cardiac acoustic biomarkers, which have been shown to provide actionable data to optimize therapy and improve patient outcomes. Physicians receive notifications based on biomarker trends and values, allowing them to modify patient therapy (e.g., change drug dosage) before there is a significant deterioration of heart failure status requiring hospitalization.
“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,” said Peter Bauer, Ph.D., CEO of Inovise Medical
About the Breakthrough Devices Program
The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase. Manufacturers can expect prioritized review of their submission. Innovative products that the FDA approves as part of the Breakthrough Devices Program will also benefit from the recently approved Medicare Coverage of Innovative Technology (MCIT) rule which creates a new, accelerated Medicare coverage pathway.
About Inovise Medical, Inc.
Inovise Medical has been applying artificial intelligence and machine learning techniques, as well as traditional algorithm development, to the problem of heart failure for 15 years. To learn more about Inovise Medical, visit https://inovise.com/.
CONTACT
Gregg Harris, BS, MBA
Director, Regulatory Affairs & QA
Inovise Medical, Inc.
harrisg@inovise.com
(503) 431-3820
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Original Source:
Inovise Receives Breakthrough Device Designation for Novel Non-Invasive System to Remotely Monitor Risk of Decompensation in Heart Failure Patients
