Genetesis, Inc. announced today that its flagship product, CardioFlux®, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome.
CardioFlux®, the most advanced commercially available magnetocardiograph (MCG), leverages highly sensitive room temperature magnetometers to deliver noninvasive measurement of the heart’s naturally-generated magnetic fields.
To meet the criteria for Breakthrough Designation, CardioFlux® demonstrated the potential for providing a safer, more precise, lower cost, and faster diagnosis for non-ST elevated myocardial infarction (NSTEMI) in the emergency room. Being a completely noninvasive, radiation-free diagnostic scan, requiring no pharmaceuticals or intravenous radioactive contrast agents, the 90-second CardioFlux test represents the most patient-centric solution for health care systems struggling to manage cost and quality of care for cardiac patients.