Wire · regulatory
FDA authorizes first AI tech for visualizing coronary inflammation in CT scans
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Fusion42 · 29 July 2026 · Fusion42 review
The US FDA has granted de novo market clearance to Caristo Diagnostics' CaRi-Heart technology. This is the first AI-powered tool that can directly visualize and quantify coronary inflammation from standard CT scans, enabling a more precise assessment of a patient's future heart attack risk.
This Wire brief sits within Fusion42's coverage of Diagnostics.
◆ ◆ The Wire takeaway
The FDA has created a new category for AI that predicts future risk, not just detects existing disease. The regulatory pathway is now proven for prognostic tools, but the competitive bar for all imaging AI just moved from detection to prediction.
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1 source · 29 Jul 2026
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