Sensydia’s Cardiac Monitor Designated a Breakthrough Device

Sensydia’s Cardiac Performance System has been granted the FDA’s Breakthrough Device designation.

The noninvasive cardiac monitoring device reports critical heart performance measurements to physicians for evaluation of patients with advanced and persistent heart failure, without requiring an in-hospital catheterization procedure or ultrasound assessment.

The device uses biosensors to gather heart sound data and applies machine learning to compute multiple hemodynamic measurements, delivering a report via an iPad app. It can measure ejection fraction, for which it has already received FDA clearance, as well as cardiac output, pulmonary artery pressure and pulmonary capillary wedge pressure.