REGULATION

The software suite inHEART Models is composed of inHEART Models Shaper and inHEART Models Explorer, a medical devices of Class IIa that are CE marked (Registration No HD 1324221-1). A Class I version of this software suite is registered to the FDA (Establishment Registration Number 3018302800) and the class II version is currently FDA 510(k) pending.

While their intended uses cover the image segmentation tools to transform medical images into a digital 3D model of the patient’s heart, they do not cover the identification of ablation targets that will be used in the clinical trial. An IRB (Institutional Review Board) approval will be necessary to conduct the clinical trial. We expect to include this feature in future versions of the product following this clinical study.