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Philips advances cardiac MR with FDA clearance for SmartHeart AI

SmartHeart AI is a workflow planning solution designed to facilitate the application of tools within Philips’ broader cardiac MR suite.

Ross Law March 09 2026

The US Food and Drug Administration (FDA) has cleared Philips’ SmartHeart AI, setting clinicians up with a tool to streamline cardiac magnetic resonance (MR) workflows.  

MR of the heart is viewed as one of the most technically demanding application of the imaging technology as compared with other organs, with synchronous cardiac and respiratory gating or breath-holding techniques a necessity to overcome motion artifacts that hinder diagnostic evaluation of cardiac MR scans.

Trained on over 1,200 MR datasets, SmartHeart AI is designed to automate 14 standard and advanced cardiac views in under 30 seconds. According to Philips, this provision serves to reduce operator variability, improve workflow consistency, and draw down on the need for manual readjustments when conducting cardiac MR.

Meanwhile, Philips asserted that SmartHeart can reduce the number of breath-holds required by patients for basic views by up to 75%, resulting in improved patient comfort during cardiac MR evaluation.

With SmartHeart’s FDA clearance, the workflow tool supports the orchestration of additional AI tools within Philips’ broader cardiac MR suite. CINE FreeBreathing is designed to improve diagnostic imaging without the need for breath-holds, thereby improving comfortability during cardiac MR for patients who cannot hold their breath or have irregular heart rhythms. Cardiac Motion Correction can be applied to correct both cardiac and respiratory and is intended to result in more definitive diagnoses. Meanwhile, CardiacQuant Perfusion provides non-invasive quantitative assessment of myocardial perfusion to support more objective diagnosis of subtle perfusion deficits.

Ioannis Panagiotelis, Philips MR business lead, said: “With SmartHeart embedded directly into the planning workflow, Philips is fundamentally redefining how CMR is performed - transforming it from a highly specialised, time-intensive procedure into a streamlined, intelligent, and scalable solution.”

The application of AI is having a pronounced impact in the healthcare space, particularly in streamlining imaging workflows to advance diagnostic accuracy and reduce the time practitioners outlay on MRI and related imaging protocols. According to a report by GlobalData, the combined AI market across healthcare was valued at $11.9bn in 2024 and is expected to reach a valuation of $57.4bn in 2029.

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