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Home » Philips gets FDA nod for AI-powered SmartHeart cardiac planning tech

Philips gets FDA nod for AI-powered SmartHeart cardiac planning tech

March 6, 2026 By Sean Whooley

Philips SmartHeart MR Workflow
The SmartHeart AI-powered MR workflow. [Image courtesy of Philips]
Philips (NYSE: PHG) announced today that it received FDA 510(k) clearance for its SmartHeart planning solution.

SmartHeart, an AI-powered cardiac magnetic resonance (MR) planning solution, aims to simplify one of the most demanding MRI exams. It automates the planning process in under 30 seconds to make cardiac MR more consistent and accessible.

Cardiac MR exams traditionally require experienced operators. They need to navigate complex scan planning, breath-hold coordination and patient-specific variations. Integrating AI directly into the planning workflow automates these steps in a single click. With this, SmartHeart delivers stable workflows, reduces workload and supports consistent image quality.

SmartHeart fully automates 14 standard and advanced cardiac views in less than 30 seconds. Philips trained it on 1,200 cardiac MR datasets so the AI provides reliable performance across a range of patient anatomies.

Amsterdam-based Philips said the solution can support health systems as they face ongoing staffing shortages amid rising demand for advanced imaging. It can reduce operator variability and improve workflow consistency. The technology makes cardiac MR more accessible to technologists with varying experience levels.

Features of the SmartHeart technology

Philips said that SmartHeart can reduce the number of breath holds for basic views by up to 75%. It supports comfort, particularly for those with dyspnea, arrhythmias, pediatric patients, or anxiety.

The platform comes as part of Philips’ growing portfolio of AI-enabled cardiac MR innovations. Julia Strandberg, the company’s chief business leader of Connected Care, recently spoke to MassDevice about AI and the company’s connected care ecosystem.

With FDA clearance, SmartHeart can now deliver innovations like CINE FreeBreathing, Cardiac Motion Correction (MoCo) and CardiacQuant Perfusion.

CINE FreeBreathing enables diagnostic-quality imaging without the need for breath holds. It helps improve patient comfort for those unable to hold their breath or those who have irregular heart rhythms.

Cardiac MoCo corrects for both cardiac and respiratory motion. It delivers robust insights for a more definitive diagnosis.

Philips designed CardiacQuant Perfusion to provide non-invasive, non-ionizing quantitative assessment of myocardial perfusion. It supports clinicians in the diagnosis of subtle perfusion deficits more objectively.

Ioannis Panagiotelis, business leader, MR at Philips, said:

“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. 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. This empowers clinicians to deliver consistent, precision cardiac care to significantly more patients.”

Filed Under: Artificial Intelligence (AI), Cardiovascular, Digital Health, Health Technology, Imaging, Machine Learning (ML), Software / IT Tagged With: FDA, Philips

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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