What Changed at Caristo Diagnostics

Every material change AI Health Index has tracked at Caristo Diagnostics: new modules, model and architecture updates, clinical evidence, regulatory status, security certifications, and integration depth. Each entry states what changed, cites its source, and carries our read on what it means for a buyer. The graded assessment of this vendor across all fifteen capability axes sits on its index profile.

Funding rounds, valuations, and awards are not product changes and are not logged here. Acquisitions appear only where there is direct product impact.

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Impact

Type

1 entry

Showing changes for Caristo Diagnostics only.Show the full log

July 2026

C

Caristo Diagnostics

Jul 29, 2026

HighVerified

Regulatory / FDA

The FDA granted De Novo authorization (DEN250042) for CaRi-Heart, which quantifies coronary inflammation from routine coronary CT angiography and estimates a 10 year cardiovascular mortality risk. Caristo announced it on 29 July and plans a US commercial launch in the third quarter, expanding through the fourth. It joins CaRi-Plaque, cleared in February 2025, so plaque and inflammation can be read from one scan.

Our read

Until July, CaRi-Heart was limited to investigational use in the US. The company has not yet published the US indication or any conditions attached to the authorization, so ask for both before using the risk estimate in care. Category III CPT codes 0992T and 0993T, effective 1 January 2026, give practices a way to code it.

Related axis: FDA and Regulatory StatusVendor announcementView source