Cleerly vs Infervision

Payer rules settle the coronary CT question for a US cardiac CT program or radiology group billing plaque analysis. Cleerly says CPT Category I code 75577 applies from January 1, 2026 and that Aetna requires an FDA-cleared platform, joining UnitedHealthcare, Cigna, Humana, BCBS Kansas City, Excellus BCBS and EviCore. openFDA holds six Cleerly records, the newest being Cleerly Plaque (K261210, decided July 29, 2026), and Cleerly lists a PowerScribe integration. It says its ISCHEMIA product showed higher diagnostic accuracy and AUC than FFRCT and stress testing against 868 invasive FFR measurements in the CREDENCE trial.

Infervision lists InferRead CT Coronary among its products, and openFDA shows no 510(k) for it under the three Infervision applicant names. Its cleared CT work is lung nodule detection and head CT stroke triage, alongside surgical planning and RECIST software. The Lung CT page calls the software "PACS and RIS friendly," on-premise or cloud, and names no PACS vendor. A lung screening program reading chest CTs is the Infervision case. A US cardiac CT program that bills plaque analysis crosses Infervision off.