December 8, 2016 — Corsens Medical Ltd. announced that it has received clearance for a Pre-Marketing Notification (510(k)) with the U.S. Food and Drug Administration (FDA) for its Corsens Cardiac Monitor (patents pending).
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 device 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. It is intended to provide continuous monitoring of the heart activity with the assessment of patient's condition relative to their cardiac rhythm. Continuous monitoring is critical for detection of myocardial infarction. Rapid detection is critical for patient survival. In previous studies, conducted at the Ziv Medical Center, Safed, Israel, the Corsens Cardiac Monitor demonstrated stable, reproducible and consistent cardiac contractility changes in patients undergoing heart catheterization procedures.
The Corsens Cardiac Monitor has been developed in part with intellectual property licensed from the Sheba Medical Center at Tel Hashomer (Israel).
For more information: www.corsensmed.com