inHeart 3D Cardiac Ablation Planning Software Cleared

FDA has cleared an inHeart 510(k) for its inHeart Models software suite that enables 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use during cardiac ablation, such as ventricular tachycardia (VT).

The device is intended to address many of the challenges of conventional VT ablation with its proprietary segmentation algorithm that analyzes preprocedural computed tomography or magnetic resonance images to create highly detailed, interactive 3D models of the heart, the company says. “This information allows physicians to optimize treatment strategies based on each patient’s unique cardiac anatomy and supports pre-procedural planning and seamless integration into all major electroanatomic mapping (EAM) systems,” it says. “Early clinical evaluations have shown a potential to reduce VT procedure times by 60% as compared to the conventional approach (from 5 hours to less than 2 hours).”