Philips has received FDA 510(k) clearance for SmartHeart, an artificial intelligence–based planning tool designed to automate key steps in cardiac MR exams.

The Amsterdam-based imaging technology company said the software is intended to simplify scan planning and reduce operator variability during cardiac MR procedures.

Cardiac MR imaging is widely used to evaluate heart structure and function but typically requires experienced technologists to manage complex planning tasks, patient breath-holds and anatomy-related adjustments. Philips said SmartHeart integrates AI directly into the scan planning workflow to automate those steps.
According to the company, the software can generate 14 standard and advanced cardiac imaging views in less than 30 seconds. The underlying algorithm was trained using more than 1,200 cardiac MR data sets to support performance across different patient anatomies and follow-up imaging scenarios.

Philips said the automation is designed to reduce manual adjustments during exam setup and help standardize imaging across technologists with varying levels of experience.

“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.”

The company said SmartHeart may also reduce the number of required breath-holds during certain cardiac imaging sequences. For some basic views, the system can cut breath-holds by as much as 75%, which may benefit patients with dyspnea, arrhythmias or anxiety, as well as pediatric populations.

SmartHeart is part of Philips’ broader portfolio of AI-based cardiac MR technologies. The suite also includes CINE FreeBreathing, which enables imaging without breath-holds; Cardiac Motion Correction (Cardiac MoCo), which compensates for cardiac and respiratory motion; and CardiacQuant Perfusion, a tool designed to quantify myocardial perfusion without ionizing radiation.

With the FDA clearance, SmartHeart is now approved for clinical use in the United States. Philips said the technology is intended to help radiology and cardiology departments manage growing imaging demand while addressing workforce constraints.

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