Philips Receives FDA Clearance for AI-Powered SmartHeart Cardiac MR Planning Tool

Royal Philips has received FDA 510(k) clearance for SmartHeart, an AI-powered cardiac MR planning solution designed to simplify one of the most technically demanding MRI exams, announced in a press release.

SmartHeart integrates artificial intelligence directly into the cardiac MR planning workflow, automating the process in under 30 seconds. The system generates 14 standard and advanced cardiac views using an AI model trained on more than 1,200 datasets. This automation reduces operator variability and helps maintain consistent image quality across different patient anatomies.

The tool also improves patient comfort by reducing the number of breath holds required for basic views by up to 75%, which can benefit patients with respiratory or cardiac conditions. By streamlining setup and reducing manual adjustments, SmartHeart aims to increase productivity and efficiency in MR departments.

SmartHeart is part of Philips’ broader AI-enabled cardiac MR suite, which includes features such as CINE FreeBreathing for imaging without breath-holds, Cardiac Motion Correction for compensating motion artifacts, and CardiacQuant Perfusion for quantitative perfusion analysis. With FDA clearance, the suite is now approved for clinical use in the United States.