Technology | May 28, 2015

FDA Clears InvisionHeart Mobile ECG Technology

Device uses secure cloud-based platform to capture, report and store diagnostic-quality ECGs

InvisionHeart, InvisionECG, FDA clearance

Image courtesy of InvisionHeart


May 28, 2015 — The U.S. Food and Drug Administration (FDA) has cleared the InvisionECG technology from InvisionHeart. The mobile electrocardiogram (ECG) technology uses a secure cloud-based, healthcare IT platform to capture and manage 12-lead ECGs.

The system offers the ability to read and visually compare, confirm, report and store diagnostic-quality ECGs. This is all done on a browser-based, secure, healthcare IT platform which provides access to ECGs anywhere and anytime an authorized healthcare professional has Web access via an appropriate browser. This will potentially lead to earlier cardiac diagnosis, which improves survival when “time is tissue.” New data in both the Journal of the American Heart Association and the Journal of the American Medical Association has identified a delay in cardiac diagnosis within the hospital setting that is associated with increased mortality.

The company expects its cloud-based ECG solution to be available for clinical use in the early third quarter of 2015.

For more information: www.invisionheart.com

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