Eko CORE 300 AI stethoscope goes on sale in US for $199

Key takeaways

• Eko Health began selling the CORE 300 in the United States on 22 October 2026. It is a stethoscope that switches between acoustic and digital listening with a twist of the chestpiece.
• Trade reports put the device at $199. The AI murmur analysis needs an Eko+ subscription, which costs $119.99 a year after a 14-day trial.
• The FDA database lists 510(k) K261694 for the CORE 300 hardware, decided on 23 July 2026. The AI software Eko links to sits under a separate, earlier clearance, K251494.
• Eko says Canada, the United Kingdom and selected European markets come next, but it has not published dates or local prices.

Eko CORE 300: what launched and what it costs

The Eko CORE 300, an FDA-cleared hybrid stethoscope, went on sale in the US on 22 October for $199, according to Eko Health. A twist of the chestpiece switches between acoustic and digital listening, and clinicians can record heart sounds for AI murmur analysis.

The launch matters because of the price. The company describes the CORE 300 as "priced in line with premium traditional stethoscopes", which positions it against the acoustic stethoscopes most clinicians already carry rather than as a specialist cardiology tool.

The two costs need to be read together. HLTH and HIT Consultant both report the $199 hardware price, and both say the AI-powered analysis requires an Eko+ subscription at $119.99 a year. HLTH adds that a 14-day trial is included. The App Store listing for the Eko app shows Eko+ at $119.99 a year or $12.99 a month in the US.

How the hybrid chestpiece works

Most digital stethoscopes are electronic devices that stop being useful when the battery runs out. The CORE 300 takes a different approach. A mechanical twist of the chestpiece switches between passive acoustic listening and powered digital listening, and HIT Consultant reports that the acoustic mode works with no battery at all.

In digital mode, Eko says the device amplifies sound up to 35 times, with adjustable volume and active noise cancellation. It offers three filter presets: Cardiac, Pulmonary and All Purpose. A small shatter-resistant display on the chestpiece shows a real-time heart rate, which HIT Consultant says is calculated from phonocardiogram data.

Recording, visualising and storing heart, lung and body sounds happens in the Eko app over Bluetooth Low Energy. That is also where the AI analysis runs.

CORE 300 specifications and pricing

Two separate FDA clearances

Buyers should know that the stethoscope and the AI are cleared separately. The FDA's 510(k) database lists K261694 as the "CORE 300 Digital Stethoscope" from Eko Health, Inc. It was found substantially equivalent on 23 July 2026 under product code DQD, the code for electronic stethoscopes. That clearance covers the hardware.

For the "FDA-cleared AI and software", Eko's press release links to K251494. In the FDA database, that entry is "Eko Foundation Analysis Software with Transformers (EFAST)". It was decided on 12 August 2025, about a year before the CORE 300 hardware was cleared. Its listing also includes the electrocardiograph and phonocardiograph product codes. In practice, the murmur analysis is Eko's existing cleared software running on recordings from the new device, not a new algorithm cleared with it.

That distinction affects how the AI should be used. Eko and its chief medical officer, cardiologist Steven Steinhubl, describe the tool as decision support that flags suspected structural murmurs. HLTH notes that a flagged murmur may lead to echocardiography and, where appropriate, referral to a specialist. The AI does not diagnose heart disease by itself.

Why Eko is targeting everyday clinicians

In its announcement, Eko cites CDC figures: heart disease was the leading cause of death in the US in 2025, at more than 694,000 deaths, and chronic lower respiratory diseases caused more than 148,000. The pitch is that the stethoscope exam patients already get could catch valvular and structural heart problems earlier if it were digital and recorded.

"Our goal is to bring the most ubiquitous clinical exam into the precise digital era," chief executive and co-founder Connor Landgraf said in the release. Former US Surgeon General Jerome Adams, who advises Eko, is also quoted in support. HIT Consultant reports that Eko is aiming at emergency departments, pediatric units, urgent care centres and rural skilled nursing facilities, where a cardiologist is often not on hand.

Eko says it has sold more than 750,000 devices worldwide. Its lineup includes the higher-end CORE 500 digital stethoscope and a separately cleared tool for detecting low ejection fraction, according to HLTH.

Rollout outside the US and what is still unconfirmed

According to Eko, after the US launch the CORE 300 will reach Canada, the United Kingdom and selected European markets, with more countries to follow. HIT Consultant adds that regulatory filings are under way in Asia-Pacific and Latin America. Several points have not been made public as of 25 October 2026:

• Launch dates and local prices for Canada, the UK and Europe, and whether the device already holds the Health Canada, UKCA or CE approvals it needs.
• Whether $199 is a permanent list price or an introductory one. Eko's release gives no figure and only compares the price to premium acoustic stethoscopes.
• Published sensitivity and specificity data for murmur detection using recordings from the CORE 300 specifically.
• How AI features will be priced for hospitals and health systems buying in bulk, as opposed to individual clinicians.

There is also a small conflict over the launch date. Eko's release and HLTH give 22 October as the US availability date, while HIT Consultant dated the launch 23 October.

What it means

The CORE 300 cuts the cost of getting into AI-assisted auscultation to about the price of a high-end acoustic stethoscope. It also removes the main practical worry about digital models, because the device still works as a normal stethoscope when the battery is flat. The AI is not part of the $199, though. A clinician who wants murmur flagging pays $119.99 a year on top, so the first-year cost is about $319 before tax.

For health systems, the separate clearances mean procurement and compliance teams will look at the hardware and the software as two products. For the wider medical AI market, the launch shows a familiar pattern: cleared algorithms sold as a subscription on top of cheaper hardware. Bullquill has covered the same push toward diagnostic AI in Microsoft's study of its AI diagnostic system against doctors. More coverage is collected under Medical AI, FDA and Eko Health.

Sources

• Eko Health press release via PR Newswire: Eko Health Launches CORE 300 to Bring AI-Enabled Stethoscopes to Every Healthcare Professional (22 Oct 2026)
• US FDA 510(k) database: K261694, CORE 300 Digital Stethoscope
• US FDA 510(k) database: K251494, Eko Foundation Analysis Software with Transformers (EFAST)
• HLTH: Eko Health launches FDA-cleared CORE 300 stethoscope with AI-assisted heart murmur detection
• HIT Consultant: Eko Health launches CORE 300, FDA-cleared AI stethoscope (23 Oct 2026)
• Apple App Store: Eko Digital Stethoscope + ECG app (Eko+ in-app prices)