Cardiac imaging technology developer Genetesis announced today that its flagship product received FDA breakthrough device designation.
Mason, Ohio-based Genetesis’ CardioFlux magnetocardiograph (MCG) uses highly sensitive room temperature magnetometers to deliver non-invasive measurements of the heart’s naturally generated magnetic fields, according to a news release.
The FDA granted breakthrough device designation for CardioFlux in the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome.
CardioFlux received FDA clearance in March 2019 for use as a general tool for non-invasive measurements and displays of magnetic signals produced by the electric currents of the heart. Genetesis expects the breakthrough nod, on the back of the previous regulatory milestone, to mark a step in the direction of using magnetocardiography in widespread clinical use by 2021.
“We are very pleased with FDA’s vote of confidence that CardioFlux has the potential to meet a significant unmet clinical burden in emergency rooms throughout the country,” Genetesis VP of clinical, quality & regulatory affairs Dr. Robert Sokolowski said in the news release. “We are looking forward to working with the agency in making this groundbreaking technology available to the millions of patients who present with symptoms suggestive of acute coronary syndrome, and to make the patient and clinical experience that much better, safer and affordable as a result.”