Genetesis said last Friday it won FDA 510(k) clearance for its CardioFlux biomagnetic cardiac imaging platform.
The newly cleared platform combines the CardioFlux magnetocardiograph with an integrated Faraday Analytical Cloud, the Mason, Ohio-based company said.
Genetesis said that the CardioFlux uses a next-gen version of magnetocardiography that eliminates the need for liquid helium cooling, which had previously served as an obstacle to the wide-scale commercial adoption of MCG. Data from the CardioFlux is sent securely to the Faraday Analytical Cloud where it can be reviewed by physicians.
“This milestone provides emergency room physicians and cardiologists with access to new technology to measure and visualize the magnetic fields produced by the heart’s natural electrical activity,” co-founder & CEO Peeyush Shrivastava said in prepared remarks.
“These are major steps forward by the team at Genetesis. Achieving these clinical and commercial milestones enables delivery of an end-to-end medical device and cloud computing platform focused on improving patient care and reducing costs,” board chair John Rice said in a prepared release.
The company said that it recently presented an investigational study using a prototype of the device at the American College Emergency Physicians 2018 Scientific Assembly.
“Throughout the study it became evident that there is great potential for magnetocardiography and CardioFlux to positively impact the clinical workflow of patients presenting to the ED with chest pain or anginal equivalents, which represent nearly 10 million emergency room visits a year,” study presenter Dr. Margarita Pena of Ascension St. John Hospital said in a prepared statement.
“Building on the initial investigational study at Ascension St. John Hospital, we see the value in magnetocardiography (MCG) along with the 20 years of clinical investigation on the use of MCG and the diagnosis of myocardial ischemia and coronary artery disease. Ascension St. John is now collaborating with several sites to launch the largest multi-center study using MCG, to date,” Dr. Edouard Daher of Ascension St. John Hospital said in a press release.