FDA Clears inHEART 3D Cardiac Modeling Software

French devicemaker inHEART has received the FDA’s 510(k) clearance for its inHEART Models software for 3D visualization of the heart’s anatomical structures for use in planning cardiac ablation procedures.

The software analyzes computed tomography and magnetic resonance images to create an  interactive 3D model of the heart, allowing physicians to optimize treatment based on each patient's unique cardiac anatomy.

Early clinical evaluations have shown that the device has the potential to reduce ventricular tachycardia procedure times from five hours to less than two, the company said, adding that the image-guided ablations can improve procedure success rates by 15 percent.