FDA Greenlights AI for Advancing Cardiac Healthcare

Image credit: inHEART

inHEART, a French medtech pioneering the development of digital twin imagery of the heart powered by artificial intelligence (AI), has been given the greenlight from the US Food and Drug Administration (FDA) for its AI software module.

In a world first, the software enables clinicians to provide optimised, bespoke treatment by providing fully automated segmentation of CT images in 3D cardiac modelling.

Having already been available commercially within European Union countries, clinicians in the US will now also have access to the first-of-its-kind software thanks to the FDA 510(k) clearance.

Early studies of the inHEART technology have shown its use could potentially reduce ventricular tachycardia ablation procedure times by 60 percent when compared to traditional methods, thereby potentially improving safety and patient experience.

“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,” said inHEART President and CEO, Todor Jeliaskov in a statement.

“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.”

Refer to the full press release from inHEART for further details.