Bunkerhill ECG-EF

by BunkerHill Health  · Based in United States → — Generative AI for clinical reasoning and action.
Cardiology Emergency Medicine Internal Medicine

Contact for pricing
Regulatory Status Disclosed

Overview

Bunkerhill Health is a pioneering healthcare technology company dedicated to transforming patient care through the power of artificial intelligence. The company’s mission is to bridge the gap between the potential of AI in healthcare and its reality in clinical practice, turning vast amounts of health system data into actionable insights. Its flagship platform, Carebricks, is a generative AI platform for clinical reasoning and action. Carebricks analyzes structured and unstructured patient data, applies AI-powered reasoning, and automates appropriate next steps across a wide range of clinical and operational workflows. This enables health systems to surface overlooked risks, identify treatment candidates, optimize care pathways, streamline operations, and close costly care gaps without adding to clinician workload. Bunkerhill Health collaborates with a consortium of research institutions, including Stanford, Johns Hopkins, and Harvard, to develop, validate, and commercialize AI algorithms. The Bunkerhill ECG-EF tool is an artificial intelligence algorithm available within the Carebricks platform, designed to detect reduced left ventricular ejection fraction from routine ECGs.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI algorithm to detect reduced Left Ventricular Ejection Fraction (LVEF u2264 40%)
  • Analyzes routine 12-lead ECG data
  • Software-only medical device
  • Integrates with Electronic Medical Records (EMR) or ECG Management Systems (EMS)
  • Part of the Carebricks platform for clinical reasoning and action
  • Aids in early identification of patients at risk for heart failure
  • Non-invasive, rapid, and accessible cardiac diagnostic tool
  • Supports automated clinical workflows

Use Cases

  • Screening for reduced ejection fraction in adults
  • Early identification of heart failure risk
  • Proactive and equitable care delivery
  • Automating clinical operations and improving care delivery at scale
  • Surfacing overlooked cardiovascular risks
  • Closing care gaps in cardiac diagnostics

What Physicians Need to Know

ECG/EKG Analysis Capability
Bunkerhill ECG-EF is an FDA-cleared AI algorithm designed to detect reduced Left Ventricular Ejection Fraction (LVEF) from routine 12-lead ECGs. It processes 10-second ECG waveform snippets to provide predictions.
Heart Failure Risk Prediction
The tool identifies adults at risk for, but not yet diagnosed with, low LVEF (u2264 40%), a critical indicator of heart failure. This enables earlier flagging of high-risk patients, potentially before symptoms arise, to facilitate timely intervention and improve outcomes.
Cardiac Monitoring Integration
Bunkerhill ECG-EF processes digital 12-lead ECG data and transmits its analysis output to integrated third-party software systems, such as Electronic Medical Records (EMR) or ECG Management Systems (EMS).
AHA/ACC Guideline Alignment
As an FDA-cleared device, ECG-EF supports the early identification of reduced LVEF, aligning with clinical guidelines for heart failure screening and management.
Real-Time Alert Capability
Available within Bunkerhill's Carebricks platform, ECG-EF insights can trigger automated next steps, including notifying care teams, routing referrals, and initiating actions in third-party platforms.
Physician Tip

Bunkerhill ECG-EF serves as a valuable adjunctive screening tool for identifying patients with potentially reduced LVEF from routine ECGs, even in asymptomatic individuals. It's crucial to remember that it is not a standalone diagnostic device; a positive result necessitates further confirmatory testing, such as echocardiography, in conjunction with clinical judgment and patient history, to establish a definitive diagnosis. Its integration into existing workflows can help streamline the identification and referral process for at-risk patients, enabling earlier intervention for heart failure.

Bunkerhill ECG-EF is integrated into Bunkerhill's Carebricks platform, which is designed to create tailored, AI-powered workflows. This platform allows for seamless data analysis and the automation of subsequent actions, including integration with EMR and ECG Management Systems. While ECG-EF focuses on LVEF detection, the broader Carebricks platform also supports other cardiovascular AI solutions, such as workflows for identifying unrecognized atrial fibrillation and detecting mitral annular calcification (Bunkerhill MAC) and aortic valve calcification (Bunkerhill AVC) from CT scans, and partners with solutions like Cleerly for coronary artery disease assessment.

Details

Category Cardiology AI
Pricing Contact for pricing
DeploymentIntegrates seamlessly with EHRs and clinical archives.
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

Bunkerhill ECG-EF received FDA 510(k) clearance (K250649) on September 19, 2025. It is cleared for detecting left ventricular ejection fraction (LVEF) less than or equal to 40% in adults at risk for, but not already diagnosed with low LVEF, using routine 12-lead ECG data.

Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Internal Medicine

What the Web Says

Bunkerhill ECG-EF is an FDA-cleared artificial intelligence algorithm that detects reduced left ventricular ejection fraction (LVEF), a key indicator of heart failure, using data from routine 12-lead electrocardiograms (ECGs). This technology aims to enable earlier identification of patients at risk of heart failure, as echocardiography, the standard test, requires specialized equipment that may not always be available. The ECG-EF algorithm is integrated into Bunkerhill's Carebricks platform and is also available through HeartSciences' MyoVista Insights, making it accessible to various healthcare facilities.

Overall: Positive

Strengths

  • FDA-cleared for detecting reduced LVEF from routine 12-lead ECGs.
  • Enables earlier identification of patients at risk for heart failure.
  • Utilizes a common and accessible test (ECG) for screening, overcoming limitations of echocardiography.
  • Integrated into the Carebricks platform, allowing for AI-powered workflows and automated next steps in patient care.
  • Accessible to various healthcare facilities, from large systems to primary care practices, through platforms like MyoVista Insights.
  • Can potentially improve patient outcomes and save lives through early intervention.

Limitations

  • Not intended as a stand-alone diagnostic device; requires physician interpretation and further clinical evaluation.
  • Should not be used for patient monitoring or on ECGs with a paced rhythm.
  • A negative result does not rule out further non-invasive evaluation for high-risk patients.
  • Limited independent reviews from physicians, healthcare IT, or tech reviewers are publicly available outside of company announcements and partnerships.
  • No specific reviews found on Reddit, G2, or Capterra for the ECG-EF product itself.
  • While a single case study highlighted a life saved, broader data on false positives or performance across a wider patient population is not yet published.

Based on reviews from: Bunkerhill Health, HeartSciences, FDA, AI News, Fierce Healthcare

Last updated: 2026-07-19

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Press & Coverage

TNW
Bunkerhill raises $55M for hospital-built clinical AI agents
Bunkerhill Health closed a Series B funding round, raising $55 million to further develop its Carebricks platform, which allows health systems to build and deploy their own clinical AI agents. The company's total funding now stands at $55 million.
2026-07
AI News
Bunkerhill raises $55M to scale agentic AI across health systems
Bunkerhill Health secured $55 million in Series B funding to expand its Carebricks agentic AI platform, with Khosla Ventures leading the round and continued participation from previous investors. The platform aims to help hospitals deploy AI agents for various clinical and operational tasks.
2026-07
Bunkerhill Health (Press Release)
Bunkerhill Health Raises $55 Million to Help Health Systems Turn Their Best Ideas into Reality
Bunkerhill Health announced the close of its Series B funding round, totaling $55 million, led by Khosla Ventures. The funding will be used to expand its Carebricks platform, which empowers health systems to build and deploy AI agents.
2026-07
HeartSciences
HeartSciences Launches MyoVista Insightsu2122 Version 1.3 with AI-ECG Algorithm Marketplace and First FDA-Cleared Algorithm
HeartSciences commercially released MyoVista Insights version 1.3, introducing an AI-ECG Algorithm Marketplace that features Bunkerhill Health's FDA-cleared ECG-EF algorithm. This algorithm detects reduced left ventricular ejection fraction (LVEF u226440%) from routine 12-lead ECGs.
2026-06
Longevity.Technology
HeartSciences opens AI marketplace for heart care
HeartSciences launched its MyoVista Insights AI-ECG marketplace, with Bunkerhill Health's ECG-EF algorithm being the first FDA-cleared AI-ECG model available. This aims to make advanced cardiac AI more accessible in clinical practice.
2026-06
FDA
CDRH Premarket Authorizations that Used Real-World Evidence | FDA
The FDA lists Bunkerhill ECG-EF (K250649) as a premarket authorization that utilized real-world evidence. The device's performance was validated using retrospective patient records from two health systems.
2026-06
Business Wire
Bunkerhill Health Secures CMS Reimbursement Pathway for AI Cardiovascular Analysis, Receives FDA Clearance for the First AI Algorithms to Evaluate Coronary and Aortic Valve Calcium on Contrast-Enhanced Chest CTs
Bunkerhill Health announced securing a CMS reimbursement pathway for AI cardiovascular analysis and receiving FDA clearance for AI algorithms to evaluate coronary and aortic valve calcium on contrast-enhanced chest CTs. This is a significant step towards broader adoption of AI in clinical care.
2026-04
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
Innolitics' review of 2025 cardiology AI/ML SaMD 510(k) clearances includes Bunkerhill ECG-EF, noting its FDA clearance on September 19, 2025, for cardiovascular applications.
2026-01

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Frequently Asked Questions

Bunkerhill ECG-EF is an FDA-cleared artificial intelligence algorithm designed to detect reduced left ventricular ejection fraction (LVEF) from routine 12-lead electrocardiograms (ECGs). It is available within Bunkerhill's Carebricks platform, which allows health systems to create tailored, AI-powered workflows to analyze patient data, surface insights, and automate next steps like notifying care teams or routing referrals.
Bunkerhill ECG-EF has received U.S. Food and Drug Administration (FDA) clearance as an AI algorithm to aid in screening for LVEF less than or equal to 40% in adults at risk for, but not already diagnosed with, low LVEF. It is not intended to be a stand-alone diagnostic device for cardiac conditions, nor for patient monitoring, and requires further clinical evaluation for a definitive diagnosis.
Bunkerhill Health's Carebricks platform analyzes structured and unstructured patient data to apply AI-powered reasoning across all available context. While the search results mention a consortium for multi-institutional training and validation of AI algorithms, implying data sharing protocols, specific details on data privacy and security measures beyond general platform capabilities are not explicitly detailed in the provided snippets.
The current standard test for measuring ejection fraction is echocardiography, which often requires specialized equipment and expertise that may not be readily available. Bunkerhill ECG-EF offers a non-invasive, rapid, and accessible tool by enabling LVEF detection from routine 12-lead ECGs, making it possible to flag high-risk patients earlier and at a greater scale.
While specific pricing for Bunkerhill ECG-EF is not detailed in the provided information, Bunkerhill Health has secured a CMS reimbursement pathway for AI cardiovascular analysis, which provides a framework for how AI-based cardiovascular analysis can be evaluated and supported in clinical practice. This suggests a pathway for financial coverage for the use of such AI tools.
Bunkerhill ECG-EF is not intended for use as a stand-alone diagnostic device, for monitoring patients, or on ECGs with a paced rhythm. A positive result suggests the need for further clinical evaluation, and a negative result in a high-risk patient should not rule out further non-invasive evaluation.
Bunkerhill ECG-EF is an FDA-cleared AI algorithm that aids in screening for reduced LVEF. While the search results highlight its ability to detect reduced LVEF from routine ECGs, specific metrics of its accuracy (e.g., sensitivity, specificity, AUC) compared directly to echocardiography are not provided in these snippets. However, it is designed to enable earlier identification of patients who may benefit from further diagnostic evaluation.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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