News | Patient Monitors | May 26, 2016

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

Monitor is intended to detect heart contractility parameters required for continuous heart function monitoring

Corsens Cardiac Monitor, FDA 510k pre-market notification

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:

Related Content

Feature | Cardiac Diagnostics | By Robert L. Quigley, MD, DPhil

Atherosclerotic cardiovascular disease (ASCVD), caused by plaque buildup in arterial walls, is one of the leading causes ...

Home January 23, 2024
News | Cardiac Diagnostics

September 5, 2023 — GE HealthCare announced the launch of a handheld, wireless ultrasound imaging system designed for ...

Home September 05, 2023
Feature | Cardiac Diagnostics | By Kelly Patrick

The global ambulatory diagnostic cardiology market was valued at $2.6 billion in 2022 and is forecast to rise to $3.3 ...

Home May 15, 2023
News | Cardiac Diagnostics

February 8, 2023 — Results of research that identified new causes of Atherosclerotic Coronary Artery Disease, or ASCAD ...

Home February 08, 2023
News | Cardiac Diagnostics

September 15, 2022 - Happitech has announced the launch of its FastStart Research app. The Amsterdam-based digital ...

Home September 15, 2022
Feature | Cardiac Diagnostics | by Kelly Patrick

Like most healthcare markets, the diagnostic cardiology market has had a bumpy ride in recent years. The COVID-19 ...

Home August 23, 2022
Feature | Cardiac Diagnostics | By Adam Saltman, MD, PhD

Before opining on the future of cardiac health, I think it’s important to define what “cardiac health” actually is. If ...

Home May 04, 2022
News | Cardiac Diagnostics

January 31, 2022 — Scientists have developed an artificial intelligence (AI) system that can analyze eye scans taken ...

Home January 31, 2022
News | Cardiac Diagnostics

November 10, 2021 — Abbott released new global market research from its Beyond Intervention initiative, the company’s ...

Home November 10, 2021
Feature | Cardiac Diagnostics | By Dave Fornell, DAIC Editor

October 29, 2021 — A new guideline for the evaluation and diagnosis of chest pain was released this week that provides ...

Home October 29, 2021
Subscribe Now