Eko's CORE 300 Gets FDA 510(k) Clearance: Traditional Listening and 35x Digital Amplification in One Chestpiece, With AI Heart Murmur Screening Through the App

On October 22, digital stethoscope maker Eko Health announced that its new CORE 300 had received FDA 510(k) clearance and gone on sale in the U.S., cleared for adult and pediatric patients. Eko says it is the first stethoscope to integrate traditional acoustic and digital listening in a single chestpiece: a twist of the chestpiece switches between traditional mode and three digital modes (Cardiac, Pulmonary and All Purpose), the digital modes offer up to 35x amplification with active noise cancellation, a display on the chestpiece shows heart rate in real time, and traditional mode keeps working without battery power. Connected to the Eko App, it can use the company's FDA-cleared AI for structural heart murmur detection, but that requires a paid Eko+ subscription ($119.99 a year after a 14-day trial). The website currently lists it at $199 (with a struck-through $249), and launches in Canada, the UK and select European markets are planned. Eko says it has delivered more than 750,000 devices.

A twist of the chestpiece, from ears to AI

The stethoscope is the most common exam tool in medicine, and Eko is positioning CORE 300 as the product that brings digital listening and AI to many more healthcare professionals. On October 22, the California-based company announced that CORE 300 had received FDA 510(k) clearance for use in adult and pediatric patients, and that it was on sale through its U.S. website from that day.

Eko says it is the first stethoscope to integrate traditional acoustic and digital listening directly into a single chestpiece. Clinicians twist the chestpiece to move between familiar traditional listening and three digital modes (Cardiac, Pulmonary and All Purpose). The digital modes offer up to 35x amplification, adjustable volume and active noise cancellation, and a small display on the chestpiece shows heart rate in real time. The website lists battery life as 120 hours of clinical use (about 780 minutes of continuous use), with USB-C charging and a shatter-resistant display; when the battery runs out, traditional listening still works.

The AI costs extra

The AI lives on the phone. Connected to the Eko App, CORE 300 can record, visualize and save heart and lung sounds and run Eko's previously FDA-cleared algorithm for structural heart murmur detection, with the app summarizing potential murmurs and other abnormal findings. The website says these findings are not a diagnosis and are meant to help the clinician reach one; AFib detection still requires the more expensive CORE 500.

Using the AI requires an Eko+ subscription. A purchase includes a 14-day trial, after which the membership renews automatically at $119.99 a year; a monthly plan is also offered. On hardware, Eko's press release says CORE 300 is priced in line with premium traditional stethoscopes, and the website currently shows $199, with $249 struck through.

Why it matters

In the press release, Eko CEO Connor Landgraf says the company's goal is to bring the most ubiquitous clinical exam into the digital era, and that Eko has delivered more than 750,000 devices. Citing CDC data, the release says heart disease remained the leading cause of death in the U.S. in 2025, responsible for more than 694,000 deaths; a murmur, wheeze or abnormal heart rate heard during a routine exam is often a signal that further evaluation is needed.

Making digital and AI features an add-on mode of a traditional stethoscope lowers the barrier for clinicians to change their habits: when they do not want the AI, it is simply a regular stethoscope. The trade-off is that the AI sits behind a subscription, so the hardware price alone understates the real cost. After the U.S. launch, CORE 300 will roll out in Canada, the UK and select European markets. The press release does not publish clinical validation data for CORE 300 itself; the murmur detection accuracy rests on the earlier clearance of the algorithm.

via: PR Newswire: Eko Health Launches CORE 300 to Bring AI-Enabled Stethoscopes to Every Healthcare Professional, Eko Health: CORE 300 product page