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Caristo wins FDA authorization for cardiovascular risk predictor
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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.
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1 source · 5 Aug 2026
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