Philips Wins FDA Nod for SmartHeart AI Cardiac MR Planning Tool

Philips has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for SmartHeart, an artificial intelligence (AI)-powered cardiac MR planning solution that the company hopes will help reduce workload on technologists while supporting consistent image quality.

Cardiac MR exams historically require experienced operators to undergo complex scan planning, breath-hold coordination, and patient-specific variations. SmartHeart automates these steps with one click thanks to the AI software integrated into the planning workflow.

The enhanced process automates 14 standard and advanced cardiac views in under 30 seconds, according to Philips. It was trained on over 1,200 cardiac MR datasets, and engineered for performance on a range of patient anatomies and follow-up scenarios.

The company said SmartHeart can reduce breath holds for basic views up to 75%. This is especially comfortable for people with dyspnea, arrhythmias, pediatric patients, or anxiety.

Other features of SmartHeart include Cardiac Motion Correction (Cardiac MoCo), which corrects for both cardiac and respiratory motion, and CardiacQuant perfusion, a non-invasive, non-ionizing quantitative assessment of myocardial perfusion.

“Cardiac MR is one of the most powerful tools available to assess the heart, yet its complexity and exam length have historically constrained its broader clinical impact,” said Ioannis Panagiotelis, Ph.D., Business Leader MR at Philips. “With SmartHeart embedded directly into the planning workflow, Philips is fundamentally redefining how CMR is performed—transforming it from a highly specialized, time-intensive procedure into a streamlined, intelligent, and scalable solution.” He added, “This empowers clinicians to deliver consistent, precision cardiac care to significantly more patients.”

Earlier this week, the company debuted its next-gen Rembra radiology CT designed for acute and high-demand imaging and showcased it for the first time at ECR 2026.