US FDA clears Corsens Cardiac Monitor

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Corsens Medical has received clearance for a pre-marketing notification (510(k)) with the US Food and Drug Administration (FDA) for its cardiac monitor.

The company received the following indications statement for the Corsens Cardiac Monitor: “The Corsens Cardiac Monitor records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. Corsens Cardiac Monitor may be used as a tool to measure the timing of part of the events in the cardiac cycle for adult population.” The Corsens Cardiac Monitor is designed to detect cardiac contractility parameters via a series of acoustic, accelerometers and cardiac rhythm non-invasive sensors arrayed on the patient’s chest.