Eko Health has introduced its FDA-cleared CORE 300 stethoscope, designed for adult and pediatric examinations, integrating traditional auscultation with digital sound amplification and artificial intelligence-assisted detection of structural heart murmurs. The device aims to support earlier identification of potential cardiac abnormalities during routine clinical assessments.
The CORE 300 allows clinicians to switch between conventional acoustic listening and three digital modes: Cardiac, Pulmonary, and All Purpose. Its technical capabilities include sound amplification of up to 35 times, adjustable volume, active noise cancellation, and a built-in display providing real-time heart rate measurements.
Through integration with the Eko App, healthcare professionals can record, visualize, and store heart, lung, and other physiological sounds. The company's FDA-cleared AI technology analyzes recordings to identify suspected structural heart murmurs, providing additional information to support clinical decision-making.
"The goal is to help clinicians recognize signs of heart disease earlier, during an exam patients already receive," Eko CMO Dr. Steven Steinhubl stated.
According to Steinhubl, identifying a concerning murmur may prompt further investigation through echocardiography and, where appropriate, referral for specialist evaluation or treatment. This functionality could be particularly relevant in primary care and rural healthcare settings, where access to cardiology services may be limited.
The CORE 300 is priced at $199, while access to AI-powered analysis requires an Eko+ subscription costing $119.99 annually following an included 14-day trial. The device offers up to 120 hours of battery-powered clinical use, USB-C charging, and a shatter-resistant display. Traditional acoustic functionality remains available without battery power.
The device received FDA 510(k) clearance on July 23, 2026, and became available in the United States on October 22. Eko plans subsequent launches in Canada, the United Kingdom, and selected European markets.
The introduction builds on Eko's existing cardiovascular assessment portfolio, including its CORE 500 digital stethoscope and FDA-cleared Low Ejection Fraction Tool, introduced in 2024 to support heart failure screening.
The CORE 300 represents a further development in integrating AI-assisted cardiovascular assessment into routine clinical examinations, potentially supporting earlier referrals and more accessible cardiac screening.
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