French medical device manufacturer inHeart has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI-enhanced tool that creates a 3D digital model of a patient’s heart from CT or MR images, aiding physicians before and during surgery.
The onboard AI module automatically segments the "twin" heart, simplifying complicated ablation procedures. These heart models are highly detailed and interactive, enabling clinicians to plan and visualize patient surgeries.
In a statement, inHeart said that the technology has been beneficial in risky ventricular tachycardia ablations, reducing procedure time by 60%.
Clearance from the FDA will allow inHeart image-guided cardiac surgeries to be conducted at medical institutions in the U.S. inHeart is currently used in operating rooms all over Europe.
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