The Cardiac Monitor is intended to detect heart contractility
parameters required for continuous heart function monitoring
TEL AVIV, Israel--(BUSINESS WIRE)--Corsens Medical Ltd., today announced that it has received clearance for
a Pre-Marketing Notification (510(k)) with the US Food and Drug
Administration (FDA) for its Corsens Cardiac Monitor1,2.
“Corsens Device for Detection Of Myocardial
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.
Evgeny Fizgeer, CEO of Corsens Medical Ltd, commented, “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.”
On May 2, 2016, Corsens Medical Ltd.,
announced filing of a 510(k) Pre-Marketing Notification with the US Food
and Drug Administration for the Corsens Cardiac Monitor.
About the Corsens Cardiac Monitor
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. The Corsens Cardiac Monitor 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, Israel3,
the Corsens Cardiac Monitor demonstrated stable, reproducible, and
consistent cardiac contractility changes in patients undergoing heart
catheterization procedures4. The Corsens Cardiac Monitor
has been developed in part with intellectual property licensed from the
Sheba Medical Center at Tel Hashomer (Israel).
About Sheba Medical Center at Tel Hashomer
The Sheba Medical
Center at Tel Hashomer is a university-affiliated tertiary referral
hospital that serves as Israel's national medical center in many fields.
Adjacent to Tel Aviv, it is the largest and most comprehensive medical
center in Israel and the entire Middle East. With 120 departments and
clinics, 1,700 beds, and 6,000 health professionals, the Sheba Medical
Center at Tel Hashomer is renowned for its leading-edge medicine,
scientific research, and medical education. It handles over a million
and a half patient visits a year, including 200,000 emergency visits
annually, and conducts more than two million medical tests a year.
About Corsens Medical, Ltd.
Corsens Medical, Ltd., founded
in October, 2013, is a development stage medical device company based in
Tel Aviv, Israel, developing the Corsens Cardiac Monitor. The Corsens
Cardiac Monitor is intended to participate in the global cardiac
monitoring and cardiac rhythm management devices market which is
expected to reach $26B by the end of 2020 growing at a CAGR of around
4.7% from 2015 to 20205.
1 Patents pending
2 The Corsens Cardiac
Monitor is not approved for sale in Europe.
Medical Center was established in 1910 in Safed, affiliated to Bar-Ilan
University's Faculty of Medicine. Research cooperation takes place with
the Faculty of Medicine and with Migal, the Galilee Research Institute.
Company data on file, "Corsens Device for Detection Of Myocardial
Ischemia", Clinical Study Report, Protocol No. CS-ANG-1, January 9, 2015
Global Cardiac Monitoring Market Growth, Trends & Forecasts (2014 -
2020), July 2015