FDA grants breakthrough device status to CardioFlux

By AuntMinnie.com staff writers

December 15, 2020 -- The U.S. Food and Drug Administration (FDA) granted breakthrough device designation to biomagnetic cardiac imaging technology developer Genetesis for its CardioFlux system, which diagnoses myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome.

The magnetocardiograph system uses highly sensitive room-temperature magnetometers to noninvasively measure the heart's naturally generated magnetic fields in 90 seconds.

Last year, the FDA cleared CardioFlux for use as a general tool that noninvasively measures and displays the magnetic signals produced by the electric currents of the heart. However, the breakthrough device designation is a key step in enabling magnetocardiography for widespread clinical use, which Genetesis projects will take place in 2021, the firm said.


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