From clinic to community: How AI is expanding access to early heart failure detection

The early detection of heart failure remains one of the biggest challenges in cardiovascular medicine. Millions of people worldwide suffer from heart conditions that often go undiagnosed until severe symptoms emerge, leading to emergency hospital visits and costly interventions. Traditional diagnostic tools like echocardiograms, while effective, are not always accessible due to high costs, the need for specialized training, and limited availability in primary care settings.

Recent advancements in artificial intelligence (AI) have opened new possibilities for early and efficient diagnosis. Eko Health, in collaboration with the Mayo Clinic, has developed and secured FDA approval for an AI-powered stethoscope capable of detecting low ejection fraction (Low EF) in just 15 seconds. This marks a significant shift in how heart failure is identified, providing a fast, cost-effective, and widely accessible tool that can be used in routine medical check-ups.

Transforming heart failure diagnosis with AI

Heart failure affects over 6 million people in the U.S., with nearly half experiencing heart failure with reduced ejection fraction (HFrEF). This condition limits the heart’s ability to pump blood efficiently, often leading to fatigue, shortness of breath, and fluid retention. Many cases remain undiagnosed for years, as symptoms are often attributed to aging or other health issues.

The traditional approach to diagnosing heart failure relies on echocardiography, a procedure that requires specialized equipment and trained personnel. However, this method is impractical for routine screenings in primary care settings. As a result, many patients only receive a diagnosis when their condition has significantly worsened, increasing the likelihood of hospitalizations and complications.

Eko Health’s AI-enhanced stethoscope changes this paradigm by integrating heart sound and single-lead electrocardiogram (ECG) analysis into a simple, rapid test that can be performed during a regular doctor’s visit. By leveraging AI-driven diagnostics, the device enables healthcare providers to detect early signs of heart failure without requiring expensive or time-consuming tests.

How the AI stethoscope works

The AI model embedded in Eko’s digital stethoscope utilizes a machine-learning algorithm trained on a proprietary dataset of over 100,000 ECG and echocardiogram pairs. During a routine check-up, the device records heart sounds and ECG signals, analyzing them in real time to identify signs of Low EF. The AI then provides an immediate assessment, allowing doctors to determine whether further testing or specialist referrals are necessary.

The technology is incorporated into Eko’s SENSORA™ Cardiac Early Detection Platform, which also includes FDA-cleared algorithms for detecting atrial fibrillation (AFib) and structural heart murmurs, both of which are critical indicators of heart disease. By combining these features, the platform enhances the ability of healthcare providers to perform comprehensive cardiovascular screenings within minutes.

Clinical validation and performance

Eko’s AI technology has undergone extensive clinical validation to ensure its accuracy and reliability. A study published in JACC Advances evaluated the tool in 2,960 patients across four major U.S. healthcare networks.

The AI model demonstrated an area under the receiver operating characteristic curve (AUROC) of 0.85, with a sensitivity of 77.5% and specificity of 78.3% for detecting Low EF. The study found that the AI could effectively identify patients with conduction or rhythm abnormalities, further proving its potential in early cardiovascular risk detection.

An independent validation study conducted by Imperial College London and published in Lancet Digital Health tested the AI on over 1,050 patients in real-world clinical environments. This study reported an AUROC of 0.85, with an 84.8% sensitivity and 69.5% specificity. The positive results prompted the UK National Health Service (NHS) and Imperial College London to expand the deployment of Eko’s AI technology to over 100 clinics in London and Wales.

Success in maternal aealth applications

Beyond its effectiveness in general populations, Eko’s AI has also demonstrated promising results in maternal health. A Mayo Clinic-led study in Nigeria involving nearly 1,200 pregnant women showed the AI’s ability to detect pregnancy-related cardiomyopathy—a serious condition that can lead to heart failure. The model achieved an AUROC of 0.98, with a sensitivity of 100% and specificity of 79.4%, identifying twice as many cases as traditional screening methods.

This breakthrough is particularly significant in low-resource settings, where access to specialized diagnostic tools is often limited. By using AI-powered stethoscopes in prenatal care, healthcare providers can detect heart complications early, improving outcomes for both mothers and their babies.

Impact on healthcare and accessibility

One of the key advantages of Eko’s AI technology is its potential to improve healthcare accessibility. Unlike echocardiography, which requires expensive machines and trained technicians, AI-enhanced stethoscopes are portable, affordable, and easy to use in any clinical setting. This makes them particularly beneficial for rural and underserved communities where advanced cardiac diagnostics are not readily available.

Dr. Paul Friedman, Chair of the Department of Cardiovascular Medicine at Mayo Clinic, emphasized that detecting a hidden, potentially life-threatening heart condition with a familiar tool like a stethoscope can help reduce hospitalizations and adverse events. He also noted that the technology’s portability makes it useful in both urban and remote areas, helping to bridge healthcare gaps in underserved communities.

Reducing healthcare costs and hospitalizations

Early detection of heart failure can significantly reduce healthcare costs by preventing complications that lead to emergency visits and prolonged hospital stays.

According to the American Heart Association, heart failure-related hospitalizations cost the U.S. healthcare system over $30 billion annually. By equipping primary care providers with AI-powered diagnostic tools, Eko’s technology has the potential to lower these costs by enabling early intervention and reducing the burden on emergency care services.

Moreover, rapid and accurate identification of Low EF can facilitate timely treatment, improving patients’ quality of life and long-term health outcomes. Early detection allows for the prescription of medications, lifestyle modifications, and specialist referrals before the condition progresses to a critical stage.

Future of AI in cardiovascular medicine

As telemedicine continues to expand, AI-powered diagnostic tools like Eko’s stethoscope could play a crucial role in remote healthcare. The ability to conduct cardiac screenings without requiring in-person visits could benefit patients in remote or high-risk environments. By integrating with digital health platforms, AI-based diagnostics can provide continuous monitoring and early alerts for patients with existing heart conditions.

Potential for broader AI applications

The success of AI in detecting Low EF opens doors for further advancements in cardiovascular diagnostics. Future AI models could be trained to detect additional heart conditions, such as hypertrophic cardiomyopathy, pulmonary hypertension, and early-stage coronary artery disease. Researchers are also exploring the potential for AI to analyze other physiological signals, such as respiratory patterns and blood pressure variability, to enhance cardiovascular risk assessments.

Regulatory and ethical considerations

While AI-driven diagnostics offer numerous benefits, they also present challenges in terms of regulatory approval, data privacy, and clinical adoption. Ensuring that AI models are trained on diverse patient populations is essential to avoid biases and ensure accuracy across different demographics. Additionally, healthcare providers must receive adequate training to interpret AI-generated results effectively and integrate them into clinical decision-making.

Eko Health’s AI-powered stethoscope represents a major step forward in the fight against heart failure. This technology has the potential to enhance millions of lives worldwide by providing advanced cardiac diagnostics that are accessible, cost-effective, and easy to use in primary care settings. Clinical studies have validated its accuracy, and its deployment in healthcare systems like the UK NHS demonstrates its real-world impact.

As AI continues to evolve, its role in cardiovascular medicine will likely expand, offering even more opportunities for early detection and improved patient care. By integrating AI into routine medical practice, healthcare providers can shift from reactive treatment to proactive prevention, ultimately transforming how heart disease is managed across the globe.