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Heartvue.ai and Innolitics Achieve FDA 510(k) Clearance for Heartvue.Proton, an AI ...
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Fusion42 · 4 September 2026 · Fusion42 review
Heartvue.ai and Innolitics have received FDA 510(k) clearance for Heartvue.Proton, an AI-powered cardiac MRI analysis platform that automates key cardiac measurements and integrates with hospital systems. The clearance includes a Predetermined Change Control Plan (PCCP), allowing model updates without new FDA submissions.
This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 2 Sep 2026 and 3 Sep 2026.
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The FDA's PCCP clearance now lets you update your AI clinical tools faster by skipping repeat submissions, giving you a sharper edge to keep medical models current and accelerate hospital adoption.
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2 sources · first reported 2 Sep 2026 · latest 3 Sep 2026
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