FDA clears inHeart’s digital twin of the heart

France-based medical device developer inHeart has received clearance from the U.S. Food and Drug Administration (FDA) for its AI-driven digital twin of the heart.

The company’s AI software module offers interactive 3D models of the heart generated by AI that analyzes preprocedural CT or MR images. The technology has been proven useful in preplanning ventricular tachycardia ablations, a treatment for a type of irregular heartbeat, the company said.

While the software has been commercially available to clinicians in Europe, FDA clearance now allows inHEART to market the product to hospitals across the U.S.

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