Philips Receives FDA 510(k) Clearance for AI-Powered SmartHeart

Philips Receives FDA 510(k) Clearance for AI-Powered SmartHeart
dicardiology
Published ondicardiology
Publish Date11 March 2026
Reading time1 Min

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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.

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