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FDA authorizes first AI tech for visualizing coronary inflammation in CT scans

Published

29 July 2026

Topic

regulatory

Sectors

Diagnostics

Geography

United States

Source

Read at cardiovascularbusiness.com

Verified

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. Wire is Fusion42's founder-focused intelligence feed: each story is connected to the funds and startups it names — every one with a live profile on Raise or Scout — so founders can follow the capital and the momentum behind the headline rather than just the headline itself. Wire analysis is one of the live surfaces Arthur reasons over.

◆ 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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Topics

Diagnosticsfda-approvalai-diagnosticsmedtechcardiologyprognostic-ai