Corsens Medical has secured clearance for a pre-marketing notification (510(k)) with the US Food and Drug Administration (FDA) for its cardiac monitor.
The Corsens Cardiac Monitor aims to identify heart contractility parameters required for continuous heart function monitoring.
It uses a series of acoustic, accelerometers and cardiac rhythm non-invasive sensors arrayed on the patient's chest.
The cardiac monitor provides continuous monitoring of heart activity along with the assessment of patient’s condition relative to cardiac rhythm. The system helps in providing continuous cardiac monitoring, which is crucial in detecting myocardial infarction.
Corsens has noted that in some cases, patient’s survival depends on rapid detection. It claims that in earlier studies conducted at the Ziv Medical Center, Safed, Israel, the device showed stable, reproducible and consistent cardiac contractility changes in patients undergoing heart catheterisation procedures.
The development of Corsens Cardiac Monitor was in part with the help of intellectual property licensed from Sheba Medical Center at Tel Hashomer in Israel.
Corsens Medical CEO Evgeny Fizgeer said: “We are thrilled to have reached this important milestone in the development of the Corsens Cardiac Monitor with the clearance of our Pre-Marketing Notification (510(k)) with FDA.
“We anticipate significant clinical interest for this innovative technology in the markets where the Corsens Cardiac Monitor will be cleared for commercial distribution. This is the first in a series of regulatory filings, while we continue the development of the Corsens Cardiac Monitor.”