FDA Grants Breakthrough Designation to Cardiosense’s Heart Monitoring Software

February 17, 2022

The FDA has designated Cardiosense’s algorithm to identify patients at risk of decompensated heart failure to be a breakthrough device.

The algorithm analyzes data collected from the company’s multi-sensor CardioTag device to noninvasively assess pulmonary capillary pressure, a metric that can currently only be captured through an invasive catheterization procedure.

“There are clear physiological changes that occur well before an acute heart failure event, and we look forward to working with the FDA to deliver a noninvasive solution to identify them,” said Cardiosense CEO Amit Gupta.

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