Posted by Michael Wonder on 15 Dec 2020
FDA awards Genetesis breakthrough device designation for CardioFlux imaging technology
15 December 2020 - Genetesis announced today that its flagship product, CardioFlux, has been granted Breakthrough Device Designation by the U.S. FDA for the diagnosis of myocardial ischaemia and infarction in patients with symptoms suggestive of acute coronary syndrome.
CardioFlux, the most advanced commercially available magnetocardiograph, leverages highly sensitive room temperature magnetometers to deliver noninvasive measurement of the heart’s naturally-generated magnetic fields.
