FDA OKs inHEART’s AI Software to Create 3D Heart Models

inHEART, a company delivering an artificial intelligence (AI)-driven digital twin of the heart, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its AI software module.
 
The new AI module, a first-of-its-kind software, creates fully automated CT image segmentation for 3D cardiac models. The technology has been available in the EU and now inHEART can deliver it to U.S. hospitals.
 
The solution addresses the challenges of conventional ablation with detailed, interactive 3D models of the heart generated by the proprietary segmentation algorithm that analyzes CT and/or MR images prior to a procedure. The information helps to optimize treatment strategies based on unique cardiac anatomy and support pre-procedural planning and integration into major electroanatomic mapping (EAM) systems.
 
Early clinical evaluations using inHEART demonstrated the potential to lower VT procedure times by 60% compared to the conventional approach—from five hours to less than two. The evaluations also showed image-guided ablations reduce occurrence of VT by 38% compared to conventional ablation strategies, according to the company.
 
“The addition of AI automation is an important milestone as it allows us to optimize the expertise of our team and deliver our solution within hours to physicians,” said inHEART president and CEO Todor Jeliaskov. “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.”
 
The company’s inHEART Models software suite for 3D anatomical structure visualization and analysis gained FDA 510(k) clearance in 2022.