Cleerly LABS vs HeartFlow Analysis

Direct competitors — feature-level head-to-head below. Comparability 90/100 Comparability is an AI-graded 0–100 score of how directly these two tools compete — higher means a more apples-to-apples comparison.
by Cleerly
VS
by HeartFlow

AI Verdict

Both Cleerly LABS and HeartFlow Analysis are highly comparable AI-powered tools for diagnosing and managing coronary artery disease using CT scans. While Cleerly LABS excels in comprehensive plaque characterization and tracking disease progression, HeartFlow Analysis distinguishes itself with its unique Fractional Flow Reserve derived from CT (FFRct) for functional assessment of blood flow. The choice between them may depend on whether the primary need is detailed anatomical plaque assessment or functional significance of stenoses.

Choose Cleerly LABS if…

Choose Cleerly LABS if your primary goal is a comprehensive, quantitative assessment of coronary atherosclerosis, including plaque volume, type, and stenosis, with an emphasis on tracking disease progression over time. This tool is ideal for establishing a baseline for personalized heart disease management and monitoring the efficacy of lifestyle interventions or medical therapies.

View Cleerly LABS →

Choose HeartFlow Analysis if…

Choose HeartFlow Analysis if you need to non-invasively determine the functional significance of coronary stenoses and assess their impact on blood flow (ischemia) using FFRct. This tool is particularly well-suited for guiding decisions on whether invasive procedures are necessary, providing a clearer picture of hemodynamically significant lesions.

View HeartFlow Analysis →

When choosing between Cleerly LABS and HeartFlow Analysis, physicians should consider their primary diagnostic focus and workflow integration. Cleerly LABS excels at comprehensive, AI-powered analysis of coronary CT angiography (CCTA) to detect, quantify, and characterize atherosclerosis and stenosis. It provides detailed plaque assessment, including volume and type, and offers 3D visualization of coronary arteries, aiding in personalized heart disease risk assessment and tracking disease progression over time. This tool is best suited for practices prioritizing in-depth anatomical and plaque burden analysis directly from CCTA scans, with a per-analysis pricing model that may involve out-of-pocket costs for patients.

HeartFlow Analysis, in contrast, focuses on delivering a non-invasive solution for diagnosing and managing coronary artery disease (CAD) by creating personalized 3D models and performing Fractional Flow Reserve derived from CT (FFRct) analysis. It utilizes computational fluid dynamics for blood flow simulation and offers plaque analysis, providing insights into the functional significance of stenoses. The key practical difference lies in HeartFlow’s emphasis on FFRct, which offers a functional assessment of coronary lesions in addition to anatomical details. HeartFlow is generally covered by Medicare and most U.S. commercial payers, with established CPT codes. Physicians seeking a tool that integrates both anatomical and functional assessment of CAD, with a more established reimbursement pathway, may find HeartFlow Analysis to be the more suitable option.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Quick Comparison

Feature Cleerly LABS HeartFlow Analysis
Pricing Per analysis Contact vendor for pricing
Deployment Cloud-based (AWS), web-based application, with on-site Cleerly Proxy for data transfer. Cloud-based (AWS)
BAA Available Unknown Yes AI-estimated
FDA Status 1 AI-estimated Yes AI-estimated
HIPAA Unknown Yes AI-estimated

Head-to-Head

AI-generated assessment across six dimensions based on each tool's documented features and compliance posture. Grounded in public data — not a substitute for hands-on evaluation.

Usability

Tie

Both tools offer cloud-based, web applications with 3D visualization of coronary arteries. Cleerly highlights integration with PACS, RIS, EHR via a proxy and PowerScribe for streamlined reporting [cite: The structured facts, 26]. HeartFlow also integrates with PACS and HL7, and recently introduced an interactive platform with integrated FFRct values, suggesting a highly interactive user experience. Given both emphasize seamless integration and interactive visualization, it's difficult to definitively pick a winner without direct user feedback.

Clinical Value

HeartFlow Analysis

HeartFlow Analysis excels with its Fractional Flow Reserve derived from CT (FFRct), a non-invasive method to assess the functional significance of coronary blockages, which is considered a gold standard for ischemia detection [cite: The structured facts, 15]. It boasts extensive clinical validation in over 200 studies and is endorsed by NICE, ACC, and AHA. While Cleerly LABS offers comprehensive plaque characterization, tracking, and now ischemia detection, HeartFlow's established functional assessment provides a critical clinical insight for guiding revascularization decisions [cite: The structured facts, 15, 26].

Pricing & Value

HeartFlow Analysis

HeartFlow Analysis has a significant advantage in pricing and value due to established Medicare and most U.S. commercial payer coverage for its FFRct analysis (CPT 75580) [cite: The structured facts]. It also has a Category I CPT code for plaque analysis (75577 for 2026) and has been deemed cost-effective by NICE [cite: The structured facts, 3, 7, 21]. Cleerly LABS, while now having a CPT code for plaque analysis and EviCore coverage, still notes that its analysis is often out-of-pocket for patients, making it less accessible financially [cite: The structured facts, 23, 28, 31, 33].

Enterprise Readiness

HeartFlow Analysis

Both tools are FDA-cleared, HIPAA compliant, provide BAAs, and are cloud-based on AWS, indicating strong foundational readiness [cite: The structured facts]. However, HeartFlow demonstrates broader enterprise maturity with adoption by over 1,400 institutions globally and compliance with a comprehensive list of international security and data integrity standards, including HITRUST, SOC 2 Type 2, GDPR, and ISO certifications. Cleerly's explicit mention of PACS, RIS, EHR, and PowerScribe integration is strong, but HeartFlow's wider institutional adoption and extensive certifications give it an edge [cite: The structured facts, 5, 8, 26, 29].

Innovation

HeartFlow Analysis

HeartFlow's FFRct, which uses computational fluid dynamics to non-invasively assess the functional significance of coronary stenoses, was a groundbreaking innovation that transformed the diagnostic pathway for CAD [cite: The structured facts, 15, 24]. While Cleerly's comprehensive plaque characterization and progression tracking are highly innovative for personalized risk assessment, HeartFlow's pioneering functional assessment, backed by a vast data foundation and expansion into PCI planning, represents a more established and continuously evolving innovation in the field [cite: The structured facts, 5, 6, 15, 24].

Support & Docs

HeartFlow Analysis

HeartFlow provides explicit contact information for support, including an email and phone number, and offers patient-facing resources like information kits and a hospital finder tool. While Cleerly undoubtedly offers support, its publicly available information on dedicated support channels and documentation is less explicit. HeartFlow's transparent and accessible support resources for both clinicians and patients indicate a more robust support infrastructure.

Feature-by-Feature

Detail beyond the Quick Comparison summary. For pricing, deployment, BAA, FDA, and HIPAA see the Overview tab.

Feature Cleerly LABS HeartFlow Analysis
Name Cleerly LABS HeartFlow Analysis
Company Cleerly HeartFlow
Description AI-powered, FDA-cleared web-based software for comprehensive analysis of coronary CT angiography (CCTA) to detect, quantify, and characterize atherosclerosis and stenosis, aiding in personalized heart disease management. Commercial-stage medical technology company providing software and artificial intelligence (AI) designed to deliver a non-invasive solution for diagnosing and managing coronary artery disease (CAD) by creating personalized 3D models of patients' coronary arteries from standard CT scans.
Key Features (Selection) AI-powered CCTA image analysis, Comprehensive coronary plaque assessment (volume, type), Stenosis detection and quantification, Ischemia detection (with Cleerly ISCHEMIA module), 3D visualization of coronary arteries AI-powered 3D modeling of coronary arteries, Fractional Flow Reserve derived from CT (FFRct) analysis, Plaque Analysis (quantification and characterization), Roadmapu2122 Analysis for CCTA reading, Non-invasive diagnostic assessment

Videos

Demos, reviews, and walkthroughs featuring Cleerly LABS and HeartFlow Analysis.

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Frequently Asked Questions

Cleerly LABS provides comprehensive coronary plaque assessment, including volume and type, stenosis detection and quantification, and personalized heart disease risk assessment, with an optional ischemia detection module. HeartFlow Analysis offers AI-powered 3D modeling of coronary arteries, Fractional Flow Reserve derived from CT (FFRct) analysis, and computational fluid dynamics for blood flow simulation.
Cleerly LABS is priced per analysis, with a retail price of $1500 (currently discounted to $750), and often requires out-of-pocket payment, though some insurance coverage is available. HeartFlow Analysis uses a fee-for-service model, is covered by Medicare and most U.S. commercial payers, and has established Category I CPT codes for FFRct Analysis (75580) and AI-Enabled Quantitative Plaque Analysis (75577 for 2026).
Yes, HeartFlow Analysis uniquely provides Fractional Flow Reserve derived from CT (FFRct) analysis and computational fluid dynamics for blood flow simulation. Cleerly LABS offers ischemia detection through its optional Cleerly ISCHEMIA module.
Both tools are cloud-based (AWS). Cleerly LABS utilizes an on-site Cleerly Proxy for data transfer and integrates with PACS, RIS, and EHR systems. HeartFlow Analysis is also cloud-based, implying integration capabilities for its services.
Cleerly LABS offers comprehensive coronary plaque assessment, including volume and type, and specifically highlights tracking disease progression over time. HeartFlow Analysis also includes plaque analysis for quantification and characterization as part of its features.

Backers

Who funded each tool's parent company.

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