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Wire · opportunities

Caristo wins FDA authorization for cardiovascular risk predictor

5 August 2026 · By · Wire by Fusion42

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, and 2 sources have reported it between 4 Aug 2026 and 5 Aug 2026.

◆ ◆ 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

2 sources · first reported 4 Aug 2026 · latest 5 Aug 2026

◆ Related on Wire

◆ Topics

Medtechfda-authorizationcardiovascular-riskai-diagnosticsmedtechcoronary-inflammation