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FDA Clears AI-Powered CT Segmentation Tool for Creating 3D Heart Models
Three-dimensional interactive heart models created with AI-enabled segmentation of CT scans may reduce ventricular tachycardia ablation procedure times by 60 percent.
The Food and Drug Administration (FDA) has granted 510(k) clearance for an artificial intelligence (AI)-enabled module from inHEART that delivers automated segmentation of preprocedural computed tomography (CT) scans that can create three-dimensional (3D) models of the heart.
Offering enhanced visualization of cardiac anatomy through the 3D models, the AI module can be seamlessly integrated into major electroanatomic mapping (EAM) systems, according to inHEART.
inHeart noted that image-guided procedures with the recently FDA-cleared AI module’s 3D models may lead to a 38 percent reduction in ventricular tachycardia recurrence rates. (Image courtesy of inHeart.)
The company pointed out that early clinical evaluations of the AI module have shown a capability of reducing conventional ventricular tachycardia (VT) ablation procedures from five hours to less than two hours. inHeart added that image-guided procedures with the AI module’s 3D models may lead to a 38 percent reduction in VT recurrence rates.
"Our mission is to make world-class cardiac imaging expertise available to all physicians to optimize treatment strategies, improve clinical outcomes, and treat patients in a timely manner. With our new AI module, we look forward to scaling the production of inHEART's digital twin of the heart in more centers across the U.S.,” noted Todor Jeliaskov, the president and CEO of inHEART.
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