Philips’ SmartHeart Planning Solution Gains FDA 510(k) Clearance

March 6, 2026—Philips announced that it has received FDA 510(k) clearance for its SmartHeart, an artificial intelligence- (AI-) powered cardiac MR planning solution that is designed to simplify technically demanding MRI exams.

According to the company, SmartHeart integrates AI directly into planning workflow and automates the traditional operator steps of complex scan planning, breath-hold coordination, and patient-specific variations in a single click. It is intended to support stable workflows, help reduce technologist workload, and support consistent image quality.

As summarized in the Philip’ press release, SmartHeart fully automates 14 standard and advanced cardiac views in less than 30 seconds. The AI engine is trained on more than 1,200 cardiac MR datasets 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. Additionally, it can reduce the number of breath holds for basic views by up to 75%, supporting comfort, particularly for pediatric patients and patients with dyspnea, arrhythmias, or anxiety, noted the company.

The company stated that SmartHeart is part of Philips’ full AI-enabled cardiac MR suite, which includes CINE FreeBreathing to enable diagnostic-quality imaging without the need for breath holds; Cardiac Motion Correction for correcting both cardiac and respiratory motion; and CardiacQuant perfusion for noninvasive, nonionizing quantitative assessment of myocardial perfusion.