CAMBRIDGE, Mass. and BORDEAUX, France, March 19, 2024 /PRNewswire/ — inHEART, a privately-held medical device company delivering the world’s most advanced, AI-driven digital twin of the heart, announced today that it has received FDA 510(k) clearance for its AI software module. The new AI module enables first-of-its-kind, fully automated segmentation of CT images in the creation of 3D cardiac models, allowing inHEART to deliver its solution to physicians with greater speed and efficiency. While this advancement has been commercially available to clinicians in the EU, with this clearance, inHEART will now deliver it to hospitals across the US.

“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 Todor Jeliaskov, President and CEO of inHEART. “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 US.”