Breakthrough Device Designation to ECG platform -- MEDICA - World Forum for Medicine

FDA: Breakthrough Device Designation to ECG analysis platform

07.04.2021

Image: Physician looking at the print-out of an ECG curve next to a patient; Copyright: PantherMedia/voenkor

The platform was designated as a Breakthrough Device for use with patients 40 years of age and older, without pre-existing or concurrent AFib or atrial flutter, and who are at elevated risk of stroke.

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Image: Red mannequin with electrodes at the body; Copyright: Messe Düsseldorf