Posted by Michael Wonder on 16 Feb 2022
Cardiosense receives FDA breakthrough device designation for algorithm to identify patients at risk of decompensated heart failure
15 February 2022 - Cardiosense announced today that the U.S. FDA has granted the company breakthrough device status for its novel algorithm to identify patients at risk of decompensated heart failure.
The algorithm analyses data collected from the multi-sensor CardioTag device to non-invasively assess pulmonary capillary wedge pressure, a measure that currently can only be captured through an invasive catheterisation procedure.
