Corsens Medical Ltd. Files 510(k) Pre-Marketing Notification for Corsens Cardiac Monitor

May 26, 2016 — Corsens Medical Ltd. announced it has successfully completed filing of a Pre-Marketing Notification (510(k)) with the U.S. Food and Drug Administration (FDA) for its Corsens Cardiac Monitor.

The company is seeking the following indications statement for the Corsens Cardiac Monitor: " “Corsens records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. Corsens may be used as a tool to measure the timing of part of the events in the cardiac cycle.” 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.

Alon Tomas Marmor, M.D., previously clinical professor, faculty of medicine, Bar-Ilan University, Israel, commented, "Acute myocardial infarction (MI) remains a leading cause of morbidity and mortality worldwide. Only 15-20 percent of the patients who suspect that they are having an MI and present to an emergency department have pain of cardiac origin. There is an unmet need for a device that can provide a non-invasive and quick assessment of cardiac ischemia. The Corsens Cardiac Monitor has the potential to detect myocardial contractility changes which can direct clinical management of cardiac ischemia."

For more information: www.microdel.co.il/cardiac.asp