Philips SmartHeart wins FDA clearance for Artificial Intelligence cardiac MR planning

Philips has secured FDA 510(k) clearance for SmartHeart, an Artificial Intelligence powered cardiac MR planning tool that automates complex exam setup in under 30 seconds to ease workloads and broaden access to advanced imaging.

Health systems are grappling with staffing shortages and rising demand for advanced imaging, while cardiac MR remains a key modality for assessing heart structure and function. Philips has received FDA 510(k) clearance for SmartHeart, an Artificial Intelligence powered cardiac MR planning solution that aims to simplify one of the most technically demanding MRI exams. By integrating Artificial Intelligence directly into the planning workflow, the system automates complex steps such as scan planning and breath hold coordination in a single click, supporting stable workflows, reducing technologist workload, and helping deliver consistent image quality.

SmartHeart fully automates 14 standard and advanced cardiac views in less than 30 seconds.* Trained on more than 1,200 cardiac MR datasets, the Artificial Intelligence engine is engineered to provide reliable performance across a range of patient anatomies and follow up scenarios. By eliminating repetitive manual adjustments, SmartHeart helps reduce operator variability and improve workflow consistency, making cardiac MR more accessible to technologists with varying experience levels. Philips positions the technology as a way to transform cardiac MR from a highly specialized, time intensive procedure into a streamlined, intelligent and scalable solution that supports more consistent, precision cardiac care.

For patients, SmartHeart can reduce the number of breath holds for basic views by up to 75%, which can support comfort for people with dyspnea, arrhythmias, pediatric patients, or those with anxiety, while also helping departments increase throughput using existing staff and scanners. SmartHeart is part of Philips’ broader Artificial Intelligence enabled cardiac MR suite, which now has 510(k) clearance for clinical use in the U.S. alongside tools such as CINE FreeBreathing for diagnostic quality imaging without breath holds, Cardiac Motion Correction to compensate for cardiac and respiratory motion, and CardiacQuant Perfusion for non invasive, non ionizing quantitative assessment of myocardial perfusion. By simplifying planning and lessening dependence on operator expertise, the suite is intended to expand access to high quality cardiac MR, enable earlier and more confident diagnosis of heart conditions, and support more efficient use of imaging resources.

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