15-Second Heart Failure Test: Eko’s AI Stethoscope Gets FDA Nod

What You Should Know:

Eko Health, a provider of AI-powered heart and lung disease detection today announced FDA clearance for its Low EF detection AI.

– Built in collaboration with Mayo Clinic, the AI allows U.S. healthcare providers to detect Low Ejection Fraction (LVEF), a crucial indicator of heart failure, in just 15 seconds using a standard Eko stethoscope during a routine physical exam.

Importance of Early Detection

The advancement in early detection signifies a major medical innovation for cardiovascular disease.  In the US alone, over 6 million individuals struggle with heart failure, with half experiencing HFrEF, a condition where the heart cannot pump blood efficiently. Traditionally, diagnosing heart failure often relies on echocardiography, a tool unavailable in many primary care settings due to its cost, specialized training requirements, and time constraints.  Consequently, many heart failure cases go undiagnosed until patients experience severe symptoms, leading to poorer outcomes and higher healthcare costs.

Eko’s AI Solution Integrates Seamlessly into Existing Workflows

Eko’s Low EF AI disrupts this paradigm by enabling rapid and accessible LVEF detection during routine stethoscope exams. This integration into existing workflows allows for earlier intervention and potentially life-saving treatment.  The Low EF AI seamlessly integrates with Eko’s existing SENSORA Cardiac Early Detection Platform, which already boasts FDA-cleared algorithms for detecting atrial fibrillation (AFib) and structural heart murmurs. When the AI detects Low EF during a primary care exam,  patients can be promptly referred to cardiology for definitive diagnosis and treatment planning.

Rigorous Clinical Validation Underscores Accuracy

Eko’s Low EF AI was meticulously developed and validated.  Here are some key highlights:

Robust Training: Trained on a vast dataset exceeding 100,000 paired ECGs and echocardiograms from unique patients.

Multi-Site Clinical Study: Clinically validated in a comprehensive study involving over 3,456 patients, demonstrating a strong ability to differentiate between normal and low EF.

Independent Validation: An independent study by Imperial College London, published in Lancet Digital Health, further confirmed the AI’s accuracy with an impressive AUROC of 0.85 for detecting LVEF below 40%.

Real-World Effectiveness: The success of Eko’s deployment in over 100 clinics across London and Wales following the Imperial College London study underscores its effectiveness in real-world settings.

Pregnant Women’s Health: A Mayo Clinic-led study involving nearly 1,200 pregnant women in Nigeria showcased the AI’s ability to identify twice the number of cardiomyopathy cases compared to standard care, highlighting its potential to improve maternal health outcomes.

“The stethoscope, the most recognizable symbol of healthcare, touches the lives of an estimated one billion people around the globe every year”, said Connor Landgraf, co-founder & CEO of Eko Health. “With Eko’s Low EF AI, we’ve transformed the icon of medicine into an AI-powered heart failure early detection tool that can help improve access to care for millions of patients, at a fraction of the time and cost of echocardiography. It’s been a privilege to work alongside Mayo Clinic in this groundbreaking endeavor.”