Philips Receives FDA Clearance for AI-Based SmartHeart Cardiac MR Planning Tool
Philips has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for SmartHeart, an artificial intelligence–based solution designed to automate planning for cardiac magnetic resonance (MR) exams. The software aims to simplify one of the most technically demanding MRI procedures by integrating automated planning directly into the workflow.
Cardiac MR imaging plays an important role in evaluating heart structure and function but typically requires experienced operators due to complex scan planning, coordination of breath holds, and variations in patient anatomy. SmartHeart is designed to automate these planning steps with a single click, completing the process in less than 30 seconds to support more consistent workflows and reduce technologist workload.
According to the company, the system automatically generates 14 standard and advanced cardiac imaging views and was trained using more than 1,200 cardiac MR datasets. By reducing the need for manual adjustments, the technology is intended to help minimize operator variability and enable technologists with different experience levels to perform cardiac MR exams more consistently.
“Cardiac MR (CMR) 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.”
Philips said the technology may also improve patient experience by reducing the number of breath holds required for basic views by up to 75%. This may benefit patients with conditions such as dyspnea or arrhythmias, as well as pediatric patients or those who experience anxiety during imaging exams. SmartHeart is part of Philips’ broader portfolio of AI-enabled cardiac MR technologies, which also includes tools designed to enable imaging without breath holds, correct for cardiac and respiratory motion, and provide quantitative assessment of myocardial perfusion.
