Cleerly is AI-driven coronary CT angiography (CCTA) software for quantitative plaque analysis. It processes standard 3D CCTA scans to measure and track coronary artery disease without invasive procedures.
The platform quantifies plaque volume, composition, length, and location. Composition is split into calcified, non-calcified, and low-density non-calcified plaque. It uses FDA-cleared machine learning algorithms.
Teams upload CCTA DICOM data to the cloud through Cleerly Proxy or PACS integrations. The software builds a 3D arterial model and calculates the Cleerly ISCHEMIA Index. An expert human reviewer confirms every AI analysis before reports are issued.
Cleerly targets gaps in stress testing, SPECT/PET, and qualitative CCTA reads, which can miss non-obstructive high-risk plaque. Use requires a prescription from a licensed healthcare provider and an existing CCTA scan.
Pricing
Cleerly does not publish plan names or prices. No free plan or self-serve trial is listed, though one-on-one demos are available on request. Licensing runs through institutional sales, with custom pricing for health systems, radiology groups, payors, and imaging centers.
* Disclaimer: Please note that pricing information may not be up to date. For the most accurate and current pricing details, refer to the official website.
Key Features
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Quantifies plaque volume, composition, length, and location
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Measures vessel stenosis in both 2D and 3D
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Estimates vessel-level ischemia with the Cleerly ISCHEMIA Index
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Compares serial scans lesion by lesion with Cleerly COMPARE
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Fills PowerScribe 360 and One reporting templates automatically
Use Cases
Suspected Coronary Ischemia Workup
A cardiologist evaluates chest pain without going straight to catheterization. The ISCHEMIA Index gives a vessel-level estimate from the existing CCTA scan. This can inform the choice between stenting and medical management.
Screening Non-Obstructive Plaque Risk
A physician sees a patient with a zero or low calcium score and metabolic risk factors. Quantifying low-density non-calcified plaque can reveal disease that calcium scoring and stress tests miss. This supports earlier preventive treatment.
Monitoring Lipid-Lowering Therapy Response
A clinician prescribing statins wants proof that plaque is slowing or regressing. Side-by-side baseline and follow-up scans show volume and composition changes across coronary segments.
Faster CCTA Report Drafting
A radiology department wants less manual transcription of CCTA findings. CAD-RADS scores, stenosis counts, and plaque summaries move into PowerScribe templates by API. This reduces dictation errors and shortens report turnaround.
Prior Authorization Documentation Support
Administrative teams need objective disease burden data for payors. Reports list the greatest stenosis values, locations, and threshold ranges. Plaque analysis has been reported under CPT 75577 since January 1, 2026.
Strengths & Weaknesses
Strengths
Algorithms were built and validated on over 10 million images from 40,000+ patients.
An expert human reviewer verifies each AI analysis at no additional cost.
It downgraded false-positive significant stenosis readings by 41% in the PROMISE trial (N=4,347).
It connects with PowerScribe, PowerShare, and Inteleshare for reporting and image transfer.
Plaque analysis uses CPT 75577, with coverage from Medicare, UnitedHealthcare, Cigna, and Aetna, depending on payer criteria.
Weaknesses
It needs an existing high-quality CCTA dataset and cannot act as a primary imaging modality.
Health system deployment requires custom IT setup with the Cleerly Proxy VM or VPN.
Turnaround averages 1 hour 20 minutes on weekdays up to 6 PM EST, which limits acute triage use.
Prescription-only access rules out patient self-referral and self-service registration.
Who Is This For?
Cardiologists: They get anatomical and physiological data to guide lipid-lowering therapy, anti-inflammatory treatment, or pre-interventional stenting plans.
Radiologists: They gain automated 3D vessel segmentation and plaque quantification, with findings synced to PowerScribe dictation templates.
Hospitals and imaging centers: They can add AI cardiovascular diagnostics to existing CCTA services and bill plaque analysis under CPT 75577.
Patients at risk of coronary artery disease: They receive visual reports on plaque burden that help them follow lifestyle and medication progress.
Frequently Asked Questions
Is Cleerly FDA-cleared?
Cleerly uses proprietary FDA-cleared machine learning algorithms. They quantify atherosclerosis and stenosis and estimate the likelihood of ischemia.
What happens if a scan cannot be analyzed?
Rejections occur in under 2% of scans. Poor acquisition quality or motion artifacts can prevent accurate AI segmentation.
Does insurance or Medicare cover Cleerly plaque analysis?
Medicare coverage applies to patients with acute or stable chest pain, no known CAD, and CAD-RADS 1-3. UnitedHealthcare, Cigna, and Aetna also cover it. Final coverage depends on each payer.
How does Cleerly differ from stress testing?
Stress tests assess indirect signs of reduced blood flow and carry higher false-positive and false-negative rates. Cleerly analyzes CCTA images to measure plaque burden, stenosis, and vessel-specific ischemia.
What does the Cleerly ISCHEMIA Index evaluate?
It evaluates 37 measures of heart health to judge vessel-level ischemia. Results are reported against a 0.80 FFR-equivalent threshold.
What do patients receive from a Cleerly analysis?
Patients get visual summaries and educational material explaining plaque volume and type. Physicians can use these reports during consultations.
Does Cleerly list security certifications?
The website has a Trust Center. Specific third-party badges such as SOC 2 or ISO 27001 are not publicly listed.
What clinical evidence supports Cleerly?
Validation spans trials including CREDENCE, PACIFIC, CONSERVE, PROMISE, CERTAIN, and CONFIRM2. In CERTAIN (N=775), physician diagnostic confidence rose 3 to 4 times.
Cleerly connects with Microsoft/Nuance PowerScribe 360 and PowerScribe One through an API over the Cleerly Proxy VPN or VM. It also supports uploads through Nuance PowerShare and Intelerad Inteleshare. The Cleerly Proxy links hospital PACS and RIS systems to the analysis engine.