Eko Health secured FDA 510(k) clearance and launched CORE 300, a stethoscope that carries both analog and digital listening in one chestpiece. A twist switches between them.
The digital side adds up to 35x amplification, active noise cancellation and a heart rate readout on the device itself. Paired with the Eko App, it unlocks cleared AI for structural murmur detection, moving disease screening into the physical exam.
The pitch is price. Eko says CORE 300 is priced in line with premium traditional stethoscopes, a deliberate move to push AI auscultation beyond early adopters and into ordinary clinics.
That matters most where specialists are far away. Emergency departments, crowded pediatric clinics and rural nursing facilities are exactly the settings where a murmur gets missed and the next level of care is hours down the road.
Connor Landgraf, co-founder and chief executive, said Eko has shipped more than 750,000 devices. Jerome Adams, the 20th US Surgeon General and an adviser to the company, said the appeal is that the exam still feels familiar while carrying more information.
The clinical stakes are large. Heart disease remained the leading US cause of death in 2025 at more than 694,000 deaths, and chronic lower respiratory disease killed over 148,000. Both announce themselves quietly in a stethoscope before they announce themselves in a chart.
CORE 300 ships October 22 in the US, with Canada, the UK and selected European markets to follow.
