Philips expands access to cardiac MR with FDA 510(k) clearance of AI-Powered SmartHeart

Philips expands access to cardiac MR with FDA 510(k) clearance of AI-Powered SmartHeart

Mar 06, 2026 | 3 minute read

Health systems face ongoing staffing shortages and rising demand for advanced imaging, placing additional pressure on MR departments. At the same time, cardiac MR (CMR) plays an important role in assessing heart structure and function.

Cardiac MR exams traditionally require experienced operators to navigate complex scan planning, breath-hold coordination, and patient-specific variations. By integrating AI directly into the planning workflow, SmartHeart automates these steps in a single click. It supports stable workflows, helps to reduce technologist workload, and supports consistent image quality.

Building on its leadership in cardiac MR, 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 automates the planning process in under 30 seconds, helping make cardiac MR more consistent and accessible.

One-click planning in under 30 seconds

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.

- 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."

Supporting patient comfort

For the patient, SmartHeart can reduce the number of breath holds for basic views by up to 75%, supporting comfort, particularly for individuals with dyspnea, arrhythmias, pediatric patients, or anxiety, while helping departments increase throughput with existing staff and scanners.

Part of Philips' full AI-enabled cardiac MR suite

SmartHeart is part of Philips' growing portfolio of AI-enabled cardiac MR innovations, designed to expand patient access and improve diagnostic precision. Now with 510(k) clearance, the suite is now approved for clinical use in the U.S., with additional innovations including:

• CINE FreeBreathing - Enabling diagnostic-quality imaging without the need for breath-holds, helping improve comfort for patients who cannot hold their breath or have irregular heart rhythms.
• Cardiac Motion Correction (Cardiac MoCo) - Correcting for both cardiac and respiratory motion to deliver robust insights for a more definitive diagnosis.
• CardiacQuant Perfusion- Providing non-invasive, non-ionizing quantitative assessment of myocardial perfusion, which can support clinicians in the diagnosis of subtle perfusion deficits more objectively.

Expanding access to precision cardiac care

As cardiac disease remains a leading cause of morbidity, broader access to high-quality cardiac MR may enable earlier detection, more confident diagnosis, and more proactive management of heart conditions.

By simplifying planning and reducing dependence on operator expertise, Philips' AI-enabled cardiac MR suite helps cardiology and radiology departments increase productivity without compromising diagnostic quality. Faster setup, fewer breath holds, and consistent planning supports a more comfortable patient experience and more efficient use of imaging resources.

Sources

* Patient datasets from the Netherlands, the USA and India

Media contacts

Get our latest news by e-mail

Share on social media

• https://www.philips.com/a-w/about/news/archive/standard/news/articles/2026/philips-expands-access-to-cardiac-mr-with-fda-510k-clearance-of-ai-powered-smartheart.html Link copied

Related news