The hardest part of getting AI into the exam room may not be the algorithm. It may be getting clinicians to pick up a different stethoscope. Eko Health is betting that a twist of the chestpiece can solve that problem.

The company has announced FDA 510(k) clearance and launch of CORE 300, which it calls the first stethoscope to combine traditional and digital listening in a single chestpiece. It is cleared for pediatric and adult patients. Eko says the price is in line with premium traditional models, which matters because cost has kept digital stethoscopes out of many pockets.

What the device does

Clinicians can switch between analog listening and digital modes (Cardiac, Pulmonary and All Purpose) without changing devices. Digital mode offers up to 35x amplification, active noise cancellation and a built-in display showing real-time heart rate. Paired with the Eko App, it can run the company’s FDA-cleared AI for structural murmur detection.

• Record, visualize and save heart, lung and body sounds
• Adjustable volume for noisy settings
• Multi-week battery life and USB-C charging
• Shatter-resistant display

Why it matters

Heart disease killed more than 694,000 people in the U.S. in 2025, and chronic lower respiratory diseases caused more than 148,000 deaths, according to the CDC. A murmur or wheeze found during a routine exam can be the first sign something needs follow-up. Structural heart disease is often caught late, and a better screen at the point of care could change that.

Eko says it has delivered more than 750,000 devices. The strategy here is adoption by familiarity. As Chief Medical Officer Steven Steinhubl, MD, put it, new tools have to fit the way clinicians already practice.

What to watch

Jerome Adams, MD, a former U.S. Surgeon General and medical advisor to Eko, points to rural and underserved settings, where specialty care can be hours away. That is where a low-cost murmur screen could help most. But the release offers no outcome data, and clearance does not prove that AI-assisted auscultation improves patient outcomes. Clinicians will want to see how the tool performs in real workflows, and how often it triggers unnecessary referrals.

CORE 300 is available now at ekohealth.com. Rollout to Canada, the United Kingdom and select European markets will follow.