(Mason, OH March 22, 2019 8 am) Genetesis, a medical technology company focused on using biomagnetic imaging to enable rapid, noninvasive and accurate chest pain triage, has received FDA 510(k) clearance for its cardiac imaging platform. The platform pairs the CardioFlux™ Magnetocardiograph with the integrated Faraday Analytical Cloud™ (FAC).
“This milestone provides emergency room physicians and cardiologists with access to new technology tomeasure and visualize the magnetic fields produced by the heart’s natural electrical activity,” said Peeyush Shrivastava, Genetesis Co-Founder and CEO.
CardioFlux™ technology enables simple, rapid, non-invasive cardiac imaging. CardioFlux represents a next-gen evolution of magnetocardiography (MCG); its use of optically pumped magnetometers (OPM) eliminates the need for liquid helium cooling, previously an obstacle to widescale commercial adoption of MCG. CardioFlux data is sent securely to the Faraday Analytical Cloud, from which physicians can review the functional imaging data, access a comprehensive set of web services, and hospitals can leverage an integrated billing service.