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.