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Caristo wins FDA authorization for cardiovascular risk predictor

Published

5 August 2026

Topic

opportunities

Sectors

Medtech

Geography

United States

Source

Read at yahoo.com

Verified

Fusion42 · 31 August 2026 · Fusion42 review

Caristo Diagnostics received FDA de novo authorization for CaRi-Heart, an AI tool that quantifies coronary inflammation to predict cardiovascular mortality risk over 10 years using routine coronary computed tomography angiography scans.

This Wire brief sits within Fusion42's coverage of Medtech.

◆ The Wire takeaway

The FDA's greenlight for Caristo’s AI heart risk tool opens the US market for predictive cardiovascular diagnostics. You should explore how this clearance unlocks new sales opportunities and reimbursement pathways now available.

Coverage

1 source · 5 Aug 2026

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Topics

Medtechfda-authorizationcardiovascular-riskai-diagnosticsmedtechcoronary-inflammation