Philips Receives FDA 510(k) Clearance for AI-Powered SmartHeart
Written by: Planify
Published: 11 March 2026
Updated: 16 March 2026
1 min read
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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