inHEART, a Digital Twin solution provider, has gained FDA clearance for its AI-based software module, enabling fully automated segmentation of computed tomography (CT) images to create 3D cardiac models. Prior to receiving FDA clearance, this module was approved and commercially available to clinicians in the EU.

This approval enhances the company’s ability to deliver its AI-driven digital twin of the heart to physicians, optimizing treatment strategies and improving clinical outcomes for patients with heart rhythm disorders. 

inHEART specializes in providing AI-driven digital twin solutions for heart care. It focuses on medical image analysis and cardiac modeling tailored to heart rhythm disorders. The company claims the use of inHEART has shown a potential reduction in ventricular tachycardia (VT) procedure times by up to 60%. Moreover, image-guided ablations, facilitated by the inHEART solution, are reported to decrease VT recurrence rates by 38% compared to traditional ablation methods.