Eko Health's AI Stethoscope Algorithm Receives FDA Clearance

Isabel Delgado
1 min read

Eko Health's digital stethoscope, equipped with AI technology, has obtained FDA clearance for its algorithm that can identify low ejection fraction in heart patients. This breakthrough could potentially allow primary care physicians to detect at-risk patients even before symptoms of heart failure appear. The algorithm, co-developed by the Mayo Clinic, has shown an 85% accuracy rate in identifying low ejection fraction. Eko Health, founded in 2013, has already distributed over 500,000 of its digital stethoscopes. With significant venture backing and valuation, the company continues to focus on developing new algorithms to enhance its offerings. The FDA clearance marks a significant milestone for Eko Health, paving the way for the commercialization of its software systems in the U.S., with plans for pilot rollouts to commence soon. This achievement underscores the potential of AI-powered medical technology in advancing preventive healthcare. It demonstrates how technology can empower healthcare professionals to identify and address critical health conditions earlier, ultimately benefiting patient outcomes.

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