FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Cardiac Imaging Platform Gains 510(k) Clearance

March 25, 2019
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The FDA has granted 510(k) clearance to Genetesis’ CardioFlux Magnetocardiograph, a device used for cardiac imaging.

The device performs simple, rapid and non-invasive cardiac imaging, enabling it to run various scans without the need for liquid helium cooling.

CardioFlux sends data securely to the cloud, where users can look over functional imaging data, use a set of analytical tools and manage billing.

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