Philips Announces FDA 510(k) Clearance of AI-Powered SmartHeart

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.

SmartHeart fully automates 14 standard and advanced cardiac views in less than 30 seconds.* Trained on more than 1,200 cardiac MR datasets, the AI 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.

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.

– Ioannis Panagiotelis, PhD, Business Leader MR at Philips

“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, PhD, 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.”

Sources

* Patient datasets from the Netherlands, the USA and India

Source: Philips