![15-Second Heart Failure Test: Eko's AI Stethoscope Gets FDA Green Light](https://hitconsultant.net/wp-content/uploads/2024/04/Eko-1500x827.png)
What you should know:
– Eco Healtha provider of AI-based heart and lung disease detection, today announced FDA clearance for its Low EF Detection AI.
– Built in collaboration with Mayo Clinic, the AI allows US 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 physical exam of routine.
Importance of early detection
Advances in early detection represent a major medical innovation for cardiovascular diseases. In the United States alone, more than 6 million people have heart failure, half of whom have ICFrEF, a condition in which the heart cannot pump blood effectively. Traditionally, diagnosis of heart failure often relies on echocardiography, a tool unavailable in many primary care settings due to cost, specialized training requirements, and time constraints. As a result, many cases of heart failure 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. Low EF AI integrates seamlessly with Eko's existing SENSORA cardiac early detection platform, which already has FDA-approved algorithms to detect atrial fibrillation (AFib) and structural heart murmurs. When AI detects low EF during a primary care exam, patients can be quickly referred to a cardiologist for definitive diagnosis and treatment planning.
Rigorous clinical validation underlines precision
Eko's Low EF AI has been meticulously developed and validated. Here are some highlights:
Solid training: Trained on a large dataset exceeding 100,000 paired ECGs and echocardiograms from unique patients.
Multisite clinical study: Clinically validated in an extensive study involving over 3,456 patients, demonstrating a strong ability to differentiate between normal and low EF.
Independent validation: An independent study from Imperial College London, published in Lancet Digital Health, further confirmed the accuracy of AI with an impressive AUROC of 0.85 for detecting LVEF below 40%.
Actual effectiveness: The successful rollout of Eko to over 100 clinics in London and Wales following the Imperial College London study highlights its effectiveness in real-world settings.
Health of pregnant women: A Mayo Clinic study of nearly 1,200 pregnant women in Nigeria showed AI's ability to identify twice as many cases of cardiomyopathy as standard care, highlighting its potential to improve health outcomes. maternal health.
“The stethoscope, the most recognizable symbol in healthcare, touches the lives of approximately one billion people around the world each year,” said Connor Landgraf, co-founder and 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 people. patients, at a fraction of the time and cost of echocardiography. It has been a privilege to work alongside Mayo Clinic on this groundbreaking endeavor.