Inovise Medical Receives Breakthrough Designation for Heart Failure Management System
Inovise Medical’s AUDICOR heart failure management system has been granted the FDA’s Breakthrough Device designation.
The device uses algorithms to remotely monitor and identify the risk of decompensation in patients previously hospitalized for heart failure.
The noninvasive system assesses the mechanical efficiency and electrical activity of the heart, acquiring signals through a hand-held, smartphone-connected device that sends data to a cloud for analysis. The system alerts physicians before there is a significant deterioration of heart failure status requiring hospitalization.