Cleerly ISCHEMIA vs CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00

Similar category, different focus. These tools serve overlapping but distinct needs. Comparability 65/100 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

AI Verdict

Cleerly ISCHEMIA focuses on non-invasive detection of coronary artery ischemia and plaque characterization using CCTA scans for coronary artery disease management. In contrast, the CARTO™ 3 EP Navigation System Software V8.0 is an AI-powered 3D cardiac mapping and navigation system for electrophysiologists to diagnose and treat heart rhythm disorders. While both are cardiology AI tools, they address distinct cardiac conditions and clinical workflows, making them adjacent rather than direct competitors.

Choose Cleerly ISCHEMIA if…

Choose Cleerly ISCHEMIA if you need a non-invasive, AI-powered solution to assess coronary artery disease and the likelihood of ischemia from CCTA scans. This tool is ideal for detailed plaque characterization, stenosis severity assessment, and non-invasive fractional flow reserve (FFR) estimation, guiding personalized treatment plans for heart disease.

View Cleerly ISCHEMIA →

Choose CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00 if…

Choose CARTO™ 3 EP Navigation System Software V8.0 if you are an electrophysiologist requiring an advanced 3D cardiac mapping and navigation system for interventional procedures. This system excels in enhancing the diagnosis and treatment of complex heart rhythm disorders like AFib and VT through precise catheter visualization, rapid anatomical mapping, and AI-driven signal analysis.

View CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00 →

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Quick Comparison

Feature Cleerly ISCHEMIA CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00
Pricing Contact for details Contact for pricing
Deployment Web-based platform; data transfer via Cleerly Proxy (VPN or virtual appliance) On-premise (EP lab system) with optional cloud-based data storage (CARTONET™)
BAA Available Yes AI-estimated Unknown
FDA Status Cleared AI-estimated Cleared AI-estimated
HIPAA Yes AI-estimated Unknown

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

Cleerly ISCHEMIA

Cleerly ISCHEMIA operates as a web-based platform with comprehensive interactive reports, suggesting a more accessible and intuitive user experience for diagnostic review. In contrast, the CARTOu2122 3 system is an on-premise EP lab system, indicating a highly specialized, procedural tool that requires specific on-site setup and expertise. The web-based nature of Tool A generally offers broader accessibility and simpler interaction for report interpretation.

Clinical Value

Tie

Both tools provide significant clinical value within their distinct cardiology sub-specialties. Cleerly ISCHEMIA offers crucial non-invasive diagnostic insights for coronary artery disease, including FFR estimation and plaque characterization, potentially reducing the need for invasive procedures. CARTOu2122 3, on the other hand, enhances the precision and efficacy of complex electrophysiology procedures through real-time AI-guided mapping and navigation. Both are FDA-cleared and address critical clinical needs.

Pricing & Value

Tie

Neither Cleerly ISCHEMIA nor the CARTOu2122 3 EP Navigation System Software V8.0 provides publicly available pricing information, requiring direct contact for details. This lack of transparency makes a direct comparison of their value propositions impossible without specific cost data. Both tools are specialized healthcare solutions, and their pricing is likely tailored to individual institutional needs.

Enterprise Readiness

Cleerly ISCHEMIA

Cleerly ISCHEMIA's web-based deployment, coupled with its HIPAA compliance, BAA, and explicit API integration with systems like PowerScribe, suggests easier and more scalable integration into existing enterprise IT infrastructure and radiology workflows. While CARTOu2122 3 is also FDA-cleared and HIPAA compliant for its cloud platform, its core on-premise system may necessitate more extensive hardware and network considerations for broader enterprise deployment.

Innovation

Tie

Both tools demonstrate significant innovation by applying advanced AI/ML techniques to complex cardiac challenges. Cleerly ISCHEMIA innovates in non-invasive diagnostic imaging analysis, providing detailed functional and anatomical insights from CCTA scans. CARTOu2122 3 innovates in real-time procedural guidance, using AI for enhanced 3D cardiac mapping and navigation during electrophysiology procedures. Each pushes the boundaries of AI application in its respective domain.

Support & Docs

Tie

Both companies provide clear channels for customer support, including dedicated forms for existing clients and general inquiries. Cleerly offers client support during business hours and provides online resources like publications and FAQs. Biosense Webster, as part of Johnson & Johnson MedTech, also offers sales/clinical support, product brochures, and detailed user guides for its complex system.

Feature-by-Feature

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

Feature Cleerly ISCHEMIA CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00
Name Cleerly ISCHEMIA CARTOu2122 3 EP Navigation System Software V8.0 (FG-5400-00
Company Cleerly Biosense Webster, Inc.
Tagline AI-Powered Precision for Non-Invasive Ischemia Detection Efficiency at Heart. Excellence at Hand.
Description Cleerly ISCHEMIA is an FDA-cleared AI tool that analyzes CCTA scans to non-invasively determine the likelihood of coronary artery ischemia at a vessel level, aiding physicians in personalized diagnosis and treatment planning for heart disease. The CARTOu2122 3 EP Navigation System Software V8.0 by Biosense Webster is an FDA-cleared, AI-powered 3D cardiac mapping and navigation system for electrophysiologists, enhancing diagnosis and treatment of heart rhythm disorders like AFib and VT.
Primary Categories Cardiology AI, Radiology & Imaging AI Cardiology AI, Surgical AI
Specialties Cardiology, Radiology Cardiology
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 Advanced Catheter Location (ACL) technology for accurate catheter visualization, Fast Anatomical Mapping (FAM) for rapid, high-resolution 3D cardiac maps, Connection of Choice for streamlined workflow and automatic catheter recognition, CARTO ELEVATEu2122 Module with machine learning for enhanced signal analysis and substrate characterization, CARTOSOUNDu2122 FAM Module utilizing AI/deep-learning for automated 3D left atrial anatomy creation, Enhanced CONFIDENSEu2122 Module for optimized map creation and data validation, LAT Velocity Vectors for visualizing activation wave velocity over substrate maps, Stability+ algorithm for continuous analysis of ablation catheter movement

Videos

Demos, reviews, and walkthroughs featuring Cleerly ISCHEMIA and CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00.

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Frequently Asked Questions

Cleerly ISCHEMIA integrates with existing hospital systems like PowerScribe via API, and data transfer occurs through Cleerly Proxy, a cloud-based solution with a minimal onsite footprint. CARTOu2122 3 EP Navigation System, an on-premise EP lab system, offers a streamlined workflow with 'Connection of Choice' for automatic catheter recognition and optional cloud-based data storage via CARTONETu2122.
Cleerly ISCHEMIA's diagnostic accuracy and prognostic utility for coronary ischemia have been validated in studies like CREDENCE and PACIFIC-1, demonstrating comparable or superior performance to other non-invasive measures like FFRCT, SPECT, and PET, referenced against invasive FFR. The CARTOu2122 3 System, through features like Advanced Catheter Location and Fast Anatomical Mapping, provides accurate catheter visualization and rapid, high-resolution 3D cardiac maps, which are critical for precision in electrophysiology procedures.
While specific learning curve details aren't provided, Cleerly ISCHEMIA offers comprehensive interactive web-based reports and an interactive web platform for physicians to review results in depth, suggesting training would focus on interpreting these AI-generated insights. The CARTOu2122 3 System, being a complex 3D mapping and navigation system for interventional electrophysiology, implies a more extensive learning curve for EP lab staff, with features designed to streamline workflow and simplify procedures.
The CARTOu2122 3 System includes the CARTOREPLAYu2122 Module, which records all ECG and catheter location data throughout a procedure, allowing for retroactive access to view earlier signals and catheter positions. While Cleerly ISCHEMIA provides comprehensive interactive web-based reports, specific audit-trail features for user interactions or data modifications are not explicitly detailed in the provided information.
Cleerly ISCHEMIA, being a web-based platform with data transfer via Cleerly Proxy, a cloud-based solution, appears well-suited for multi-site deployment with minimal onsite footprint and various upload options. The CARTOu2122 3 EP Navigation System is an on-premise EP lab system, meaning multi-site deployment would involve installing the system in each lab, with optional cloud-based data storage via CARTONETu2122 for data management.

Backers

Who funded each tool's parent company.

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