Cleerly

The product is AI analysis of coronary CT angiography. Cleerly Labs quantifies and characterizes atherosclerotic plaque and stenosis, and Cleerly ISCHEMIA derives a machine learning estimate of vessel level ischemia from the same imaging. There is no scanner or services layer; the company sells the algorithmic reading of a scan the customer already acquired. AI is the whole offering.

Explicitly clinical decision support. Cleerly ISCHEMIA is described as a diagnostic aid to be used with the entirety of relevant patient specific data by an interpreting healthcare provider, and results are reported by a physician. The plaque analysis produces quantitative measures the clinician incorporates, rather than issuing a standalone diagnosis. Prescription only and physician mediated, with the human retaining interpretation.

The clinical validation is published and specific: Cleerly ISCHEMIA was derived and validated using data from the CREDENCE and PACIFIC trials, and a PACIFIC sub-study reported high diagnostic accuracy against PET, FFR-CT, SPECT, and invasive FFR. The company states the ISCHEMIA prediction is based on coronary lesion morphology and plaque characteristics, and cites a training base of millions of images from more than 40,000 patients. What is less transparent is the model architecture itself and independent head to head benchmarking against other plaque analysis vendors. Strong on clinical derivation, lighter on model internals.

Among the strongest evidence bases in cardiac imaging AI. Validation draws on the multicenter CREDENCE and PACIFIC trials plus the international CONFIRM2 registry, with late breaking CONFIRM2 presentations reporting a twelve fold risk gradient based on total plaque burden. The company and independent cardiologists frame Cleerly as having invested in outcome oriented clinical studies rather than detection accuracy alone, which is precisely the evidence standard the field says is missing from most imaging AI. Buyers should note much of the foundational trial data was generated by the company's clinical network, but it is peer reviewed and multicenter.

No specific PHI handling or data governance framework was located in the materials reviewed. As a cloud analysis service processing cardiac CT studies, data stewardship terms would be a per contract matter.

No explicit HIPAA or BAA commitment was located in public materials. As a US headquartered vendor processing imaging for US providers this is likely handled contractually, but the specific posture is not published.

No SOC 2, ISO 27001, or equivalent attestation and no trust center were located in the materials reviewed.

Cleerly holds multiple FDA 510(k) clearances, including Cleerly ISCHEMIA cleared K231335 and the earlier plaque analysis clearance dating to 2020 as the first company cleared for AI quantification and characterization of coronary plaque types. Clear, current, multi product US authorization with documented clearance numbers.

No formal governance framework, subgroup performance analysis, or bias disclosure was located. The multicenter international registry base implies exposure to varied populations, but the company does not publish a governance program or demographic performance breakdown.

Cleerly operates as a CCTA analysis service that returns a physician report, sitting in the cardiac imaging and reporting pathway rather than integrating deeply with the EHR. Specific PACS, cardiology information system, and EHR connectors are not enumerated in the materials reviewed, so integration is described at the workflow level rather than through a published connector list.

Delivered as a cloud analysis service on submitted CCTA studies. Specific hosting, tenancy, and data residency terms are not published, which matters given cardiac CT studies contain identifiable imaging data.

More visible than most imaging AI on the economics that decide adoption, because the reimbursement pathway is public and specific. The plaque analysis carries Category I CPT code 75577 effective January 2026, replacing earlier Category III codes, and ISCHEMIA is billable under Category I code 75580; Medicare coverage plus commercial payer policies from UnitedHealthcare, Cigna, Humana, Aetna and others are reported to span more than 86 million covered lives. Per study product pricing to the provider is not published, but the reimbursement structure a buyer actually needs to model the return is unusually well documented.

Deliberately concentrated on coronary artery disease evaluation from CCTA, spanning plaque quantification and ischemia estimation across the diagnostic pathway for known or suspected CAD. Deep within cardiovascular imaging rather than broad across radiology, which is the source of both its evidence depth and its reimbursement wins, but it does not extend beyond cardiac.