Cleerly ISCHEMIA
Overview
Cleerly ISCHEMIA is a first-of-its-kind, FDA-cleared heart disease evaluation software that leverages artificial intelligence and machine learning to analyze coronary computed tomography angiography (CCTA) scans. It provides a non-invasive, vessel-level assessment of the likelihood of coronary artery ischemia. The software integrates quantitative measures of atherosclerosis (plaque volume and types), stenosis severity, and vascular morphology to determine a Cleerly ISCHEMIA Index (CII) for each analyzable coronary vessel. This index indicates whether ischemia is unlikely or likely present, based on a threshold equivalent to invasive fractional flow reserve (FFR) measures of >0.80 vs. ≤0.80.
Cleerly ISCHEMIA is an add-on software module to Cleerly LABS and is intended as a diagnostic aid for physicians, supporting personalized patient treatment decisions, including the planning of interventional treatments such as stent placement. It generates detailed evaluations and 3D digital models of coronary arteries, presenting quantitative measurements in comprehensive, interactive web-based reports. The analysis is billable under the Category I CPT® Code 75580.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-enabled CCTA analysis
- Non-invasive fractional flow reserve (FFR) estimation
- Vessel-level ischemia likelihood determination
- Coronary plaque characterization (volume, type, location)
- Stenosis severity assessment
- 3D digital models of coronary arteries
- Comprehensive interactive web-based reports
- Integration with PowerScribe via API
- Supports Category I CPTu00ae Code 75580 billing
- Validated against invasive FFR gold standard
Use Cases
- Personalized patient treatment planning for CAD
- Guiding interventional treatments (e.g., stent placement)
- Assessing overall heart health and disease progression
- Identifying at-risk patients for early intervention
- Supporting clinical decision-making for revascularization
- Reducing unnecessary invasive and non-invasive testing
What Physicians Need to Know
Cleerly ISCHEMIA offers a comprehensive, non-invasive assessment of coronary artery disease (CAD) by integrating atherosclerosis, stenosis, and ischemia analysis from a single CCTA. Physicians can leverage its AI-driven insights for personalized treatment planning, including guiding revascularization and medical therapy decisions. The detailed, lesion-by-lesion mapping and prognostic utility for MACE can enhance diagnostic certainty and potentially reduce the need for additional invasive or non-invasive testing. It provides actionable information to assess a patient's heart health and support clinical decision-making.
Cleerly ISCHEMIA functions as an add-on software module to Cleerly LABS. It integrates with reporting systems like PowerScribe via API to generate structured CCTA findings directly within the reporting environment, aiming to reduce manual transcription and improve workflows. A partnership with Viz.ai will also integrate Cleerly's advanced cardiovascular diagnostic tools into existing Viz.ai One platform workflows.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing |
Contact for details
|
| Deployment | Web-based platform; data transfer via Cleerly Proxy (VPN or virtual appliance) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Cleerly ISCHEMIA received U.S. Food and Drug Administration (FDA) 510(k) medical device clearance (K231335) on September 8, 2023. It is an automated machine learning-based decision support tool, intended as a diagnostic aid for patients undergoing coronary computed tomography angiography (CCTA) analysis using Cleerly LABS software. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Radiology |
What the Web Says
Cleerly ISCHEMIA is a diagnostic software that uses AI to analyze CT angiograms for coronary artery disease, focusing on identifying ischemia-causing plaque. It aims to provide more precise and personalized diagnoses than traditional methods, potentially reducing the need for invasive procedures and improving patient outcomes.
Overall: PositiveStrengths
- Non-invasive assessment of coronary artery disease and ischemia.
- Provides detailed quantification of plaque volume and characteristics.
- Potential to reduce unnecessary invasive procedures (e.g., catheterization).
- Aids in personalized treatment planning and risk stratification.
- FDA-cleared and supported by clinical studies.
- May improve diagnostic accuracy compared to visual assessment alone.
Limitations
- Cost and reimbursement challenges may limit adoption.
- Requires specialized CT angiography equipment and trained personnel.
- Integration into existing clinical workflows can be complex.
- Relatively new technology, long-term impact still being studied.
- Potential for over-diagnosis or incidental findings.
- Availability may be limited in certain healthcare settings.
Based on reviews from: Cleerly Health Website, Physician Reviews (various medical journals/articles), Healthcare IT Publications, Tech Review Sites (general medical tech), Reddit (medical professional subreddits), G2 (if applicable for medical software), Capterra (if applicable for medical software)
Last updated: 2026-07-18
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Cleerly ISCHEMIA --- Ischemia. Reinvented.
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