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FDA clears new imaging software from AI company founded by cardiologists
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Fusion42 · 4 September 2026 · Fusion42 review
Heartvue.ai obtained FDA clearance for its AI-enabled cardiac MRI imaging software, Heartvue.Proton, which automates cardiac measurement processes while integrating with hospital PACS and EHR systems. The clearance includes a Predetermined Change Control Plan allowing iterative software updates without further FDA submissions.
This Wire brief sits within Fusion42's coverage of Medtech, and 3 sources have reported it between 2 Sep 2026 and 4 Sep 2026.
◆ ◆ The Wire takeaway
FDA clearance with an included change control plan speeds your AI medical imaging software deployment in the US. Product teams can now update features incrementally without new approval delays, opening faster iteration and competitive edge.
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3 sources · first reported 2 Sep 2026 · latest 4 Sep 2026
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