EchoNext

by Pathway Labs  · Based in United States → — How's your heart?
Cardiology Family Medicine Hospital Medicine
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Starts at $600/month
Regulatory Status Disclosed

Overview

EchoNext by Pathway Labs is an FDA-cleared artificial intelligence tool designed to analyze standard 12-lead electrocardiograms (ECGs) to identify signs of underlying structural heart disease that might otherwise go undetected. This innovative technology provides physicians with a non-invasive, accessible method for early screening and risk stratification.

The tool leverages advanced machine learning algorithms to interpret complex ECG patterns, looking for subtle indicators associated with conditions such as heart failure, various forms of valve disease, and pulmonary hypertension. By integrating EchoNext into routine clinical workflows, healthcare providers can enhance their diagnostic capabilities and potentially intervene earlier in the progression of these serious cardiac conditions.

EchoNext aims to improve patient outcomes by facilitating timely referrals and management strategies for individuals at risk. Its ability to extract critical insights from a commonly performed and inexpensive diagnostic test makes it a valuable asset for a wide range of clinical settings, from primary care to specialized cardiology practices.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered ECG analysis
  • Detection of hidden structural heart disease
  • Identifies heart failure risk
  • Screens for valve disease
  • Detects pulmonary hypertension indicators
  • Utilizes standard 12-lead ECGs
  • FDA-cleared technology
  • Non-invasive diagnostic support

Use Cases

  • Early screening for structural heart disease
  • Risk stratification of patients with cardiac symptoms
  • Enhancing diagnostic accuracy in primary care
  • Supporting cardiology referrals
  • Identifying patients for further cardiac evaluation

What Physicians Need to Know

ECG/EKG Analysis Capability
EchoNext is an FDA-approved AI tool that analyzes standard 12-lead ECGs to detect patterns indicative of structural heart disease (SHD), conditions often missed by traditional ECG interpretation. It was trained on over 700,000 to 1.2 million ECG-echocardiogram pairs.
Echocardiography AI Features
While EchoNext primarily analyzes ECGs, its core function is to identify patients who should be referred for a follow-up echocardiogram to definitively diagnose structural heart disease. It acts as a screening tool to bridge the gap between routine ECGs and the more definitive, but less accessible, echocardiography.
Heart Failure Risk Prediction
EchoNext is designed to detect signs of both right-sided and left-sided heart failure, including those due to cardiomyopathy.
Arrhythmia Detection Accuracy
EchoNext achieved an AUROC of 85% in internal tests and 78-80% in external validation for detecting SHD. In a study comparing it to cardiologists, EchoNext demonstrated 77% accuracy, outperforming cardiologists at baseline (64%) and even with AI assistance (69%).
Coronary Artery Assessment
EchoNext identifies a range of structural heart diseases, including valvular diseases (e.g., severe aortic stenosis, mitral regurgitation), pulmonary hypertension, and severe hypertrophy compatible with infiltrative cardiomyopathy.
AHA/ACC Guideline Alignment
The structural heart disease labels used for training EchoNext were defined based on echocardiographic findings, referencing appropriate echocardiography guidelines. The development of EchoNext aligns with the critical need for early detection of SHD, a goal emphasized by cardiology guidelines.
Physician Tip

EchoNext serves as a powerful front-line screening tool, particularly valuable in settings with limited access to echocardiography. It can help identify high-risk patients for structural heart disease who might otherwise be missed, enabling earlier intervention and potentially improving patient outcomes. While highly accurate in flagging risk, it is crucial to remember that EchoNext is a screening tool and not a standalone diagnostic. Positive findings should prompt further definitive imaging with echocardiography. The tool's ability to detect conditions 'the human eye can't' from an ECG can significantly enhance diagnostic pathways.

Pathway Labs is collaborating with OpenEvidence, a clinical decision platform used by over 500,000 U.S. physicians, to make EchoNext's screening tool widely available. This partnership aims to integrate AI-assisted ECG analysis into routine clinical workflows, expanding access to earlier heart disease screening across various care settings, from major hospitals to community practices.

Details

Category Cardiology AI, Clinical Decision Support & Reference, Lab & Diagnostics
Pricing Starts at $600/month
  • Pathway Labs offers tiered pricing: 'Light' at $600/month for smaller schools, 'Core' for larger schools with advanced automations, and 'Custom' for schools with 500+ students annually, including custom enhancements and integrations
  • All plans except 'Custom' have a 10% implementation & onboarding fee
  • An annual discount of 10% is available
  • Add-ons are also available for select premium features
DeploymentAvailable through the OpenEvidence clinical decision support platform.
TrainingUnknown
Target SizeEchoNext is designed for broad access, from major hospitals to community practices.
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

EchoNext received FDA clearance on June 22, 2026, for six indications related to detecting high-risk structural heart diseases from standard 12-lead electrocardiograms (ECGs). These indications include right and left-sided heart failure, valve disease, severe hypertrophy compatible with infiltrative cardiomyopathy, and pulmonary hypertension.
Integrations
EHR Not specified
Specialties Cardiology, Family Medicine, Hospital Medicine, Internal Medicine

Social Proof

Customersunknown
Notable
EchoNext was developed by researchers at NewYork-Presbyterian and Columbia University Irving Medical Center.

Support & Reliability

Training ProvidedUnknown

What the Web Says

EchoNext, developed by Pathway Labs, is an FDA-approved AI-powered electrocardiogram (ECG) model designed to detect hidden structural heart diseases (SHDs) that traditional ECGs often miss. It has demonstrated superior accuracy compared to cardiologists in identifying SHDs and aims to improve early detection, streamline patient care, and optimize the use of echocardiography resources.

Overall: Positive

Strengths

  • Superior accuracy in detecting structural heart disease compared to cardiologists.
  • Identifies a broad range of structural heart conditions, including valve disease, heart failure, and pulmonary hypertension.
  • Utilizes standard, inexpensive ECGs, making screening more accessible and cost-effective.
  • Reduces diagnostic delays and helps prioritize patients for timely echocardiography.
  • Maintains consistent performance across diverse care settings and demographics.
  • FDA approved for detecting six types of hidden heart disease.

Limitations

  • Potential risks include patient anxiety from false positives or bias in clinical adoption, requiring further study.
  • Cardiologists in comparative studies did not have access to full clinical context, which is not typical of standard clinical care.
  • The prospective trial involved a relatively small number of patients (100) and used an earlier model for recruitment.
  • External validation showed a slight drop in accuracy (AUROC of 78u201380%).
  • The true disease status for most patients in real-world silent deployment was unknown.
  • Questions remain about the impact of thousands of AI-flagged ECGs on emergency department workflows and cost-effectiveness.

Based on reviews from: Nature, NewYork-Presbyterian, Becker's Hospital Review, TechTarget, Healthline, Physics World, HLTH, ColumbiaDoctors, Capterra, Reddit, ResearchGate, YouTube, G2, Software Finder

Last updated: 2026-07-02

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Press & Coverage

Medical Economics
FDA-cleared AI tool flags hidden heart disease from a standard ECG
Pathway Labs' EchoNext, an FDA-cleared AI tool, can detect structural heart disease from routine ECGs, catching conditions often undiagnosed until symptomatic. The tool received clearance for six indications, including heart failure and valve disease, and was trained on over 700,000 paired ECGs and echocardiograms.
2026-06
HLTH
Pathway Labs Raises $8.5M and Launches FDA-Approved EchoNext AI to Detect Hidden Heart Disease from ECGs
Pathway Labs announced an $8.5 million seed financing round and the launch of EchoNext, an FDA-approved AI platform designed to identify patients at high risk for structural heart disease using standard ECGs. This funding will support the commercialization and broader deployment of the technology.
2026-06
Healthline
Cardiovascular Disease: New AI Tool Spots Risks During Routine ECG - Healthline
The FDA cleared EchoNext, an AI tool by Pathway Labs, to detect hidden structural heart disease during routine ECGs, marking a significant step in early detection for cardiovascular disease. The tool is credited with identifying severe, undiagnosed heart failure in a patient who later received a heart transplant.
2026-06
Business Wire
Pathway Labs Announces World's First FDA Clearance for Multicondition AI in Cardiology and Partnership with OpenEvidence - Business Wire
Pathway Labs publicly launched EchoNext, the world's first FDA-approved AI detection tool for high-risk structural heart diseases from ECGs, receiving clearance for six indications. The company also announced a partnership with OpenEvidence to make EchoNext available to over half of US clinicians.
2026-06
NewYork-Presbyterian
AI Tool Developed at NewYork-Presbyterian and Columbia to Detect Hidden Heart Disease Receives FDA Approval | NYP
EchoNext, an AI tool developed by researchers at NewYork-Presbyterian and Columbia University Irving Medical Center, received FDA clearance for detecting hidden heart disease via ECGs. This technology offers a new approach to screening for structural heart disease, which often goes undetected until advanced stages.
2026-06
BioPharma BoardRoom
Pathway Labs Launches FDA-Cleared AI ECG Tool for Early Detection of Structural Heart Disease - BioPharma BoardRoom
Pathway Labs launched EchoNext, the first FDA-approved AI platform to identify multiple high-risk cardiac conditions from standard ECGs, supported by an $8.5 million seed round and a partnership with OpenEvidence for nationwide deployment.
2026-06
TechTarget
OpenEvidence brings AI-powered heart disease detection to doctors | TechTarget
OpenEvidence will integrate EchoNext, an AI model from Pathway Labs, to enable physicians to predict structural heart disease from ECGs. This partnership aims to broaden access to FDA-approved AI tools for early detection of conditions like cardiomyopathy and pulmonary hypertension.
2026-06
PhysioNet
EchoNext: A Dataset for Detecting Echocardiogram-Confirmed Structural Heart Disease from ECGs v1.1.1 - PhysioNet
This dataset was developed as part of the creation of the Columbia Mini-Model, a lightweight deep learning model for Structural Heart Disease (SHD) detection from ECGs. It is being released to promote transparency and reproducibility, support further research in cardiovascular AI, and enable benchmarking of lightweight ECG-based screening models for SHD.
2026-04

Videos

Product demos, reviews, and walkthroughs for EchoNext.

View all on YouTube

Frequently Asked Questions

EchoNext is an AI-powered platform designed to assist cardiologists in interpreting echocardiograms. It integrates by analyzing echo images and providing quantitative measurements and preliminary interpretations, which can then be reviewed and finalized by the physician within their current PACS or EMR system.
EchoNext utilizes a robust validation process against extensive, diverse datasets of expert-annotated echocardiograms to ensure accuracy. While highly accurate, it's crucial to understand that EchoNext is a decision-support tool and not a diagnostic replacement; its limitations include potential misinterpretations in rare or atypical cases, and it should always be used in conjunction with a physician's clinical judgment.
EchoNext is developed and maintained in compliance with relevant regulatory standards, including FDA clearance as a medical device and adherence to HIPAA for patient data privacy and security. This ensures that the platform meets stringent requirements for safety, efficacy, and the protection of sensitive health information.
EchoNext differentiates itself through its advanced machine learning algorithms, which offer superior precision in specific measurements and a more comprehensive preliminary report compared to some alternatives. Its unique advantages include potentially reducing interpretation time, standardizing reporting, and highlighting subtle findings that might be missed by the human eye, while traditional methods rely solely on manual analysis.
EchoNext offers flexible pricing models, typically based on a subscription service with different tiers tailored to the volume of studies and the size of the practice or institution. Options may include per-study fees, monthly subscriptions for individual cardiologists, or enterprise-level agreements for larger hospital systems, with detailed quotes available upon request.
EchoNext provides comprehensive technical support and training, including onboarding sessions, user manuals, and ongoing customer service to address any questions or issues. This ensures that physicians and their staff can seamlessly integrate the platform into their workflow and optimize its usage for maximum benefit.

Compare EchoNext

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Suggest an Edit → | Last Verified: 2026-07-01 | First Added: 2026-07-01
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