News and analysis on medical technology
FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

Eko Health Launches CORE 300 Stethoscope With AI Murmur Detection

The FDA-cleared device pairs acoustic and digital listening in one chestpiece and connects to Eko's murmur-detection software through a paid subscription.

By News DeskOctober 23, 20262 min read
A black acoustic stethoscope lying on a dark wooden surface
A conventional acoustic stethoscope. It is not the Eko CORE 300 described in this article. Tama998, CC0, via Wikimedia Commons · CC0
FDA cleared510(k) · K261694FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • FDA's 510(k) database shows the CORE 300 Digital Stethoscope cleared on July 23, 2026; US sales began October 22.
  • The device switches between acoustic listening and digital mode with up to 35x amplification and noise cancellation.
  • Hardware is reported at $199, with AI murmur analysis through an Eko+ subscription at $119.99 a year.

Eko Health has launched CORE 300, a stethoscope that combines conventional acoustic listening with digital amplification and connects to the company's AI software for detecting heart murmurs, the company announced on October 22. The device went on sale in the US that day through Eko's website.

The FDA's 510(k) database lists the CORE 300 Digital Stethoscope as cleared on July 23, 2026, under product code DQD for electronic stethoscopes and regulation 870.1875. Eko said the device is cleared for adult and pediatric patients.

One chestpiece, two modes

According to Eko, CORE 300 puts traditional and digital listening into a single chestpiece. HIT Consultant reported that a twist of the chestpiece switches between passive acoustic listening, which works even when the battery is drained, and active digital listening with up to 35 times amplification, active noise cancellation and cardiac, pulmonary or all-purpose filters. A small display shows heart rate in real time.

The same report gave a weight of 150 grams, interchangeable adult and pediatric diaphragms, Bluetooth Low Energy and USB-C charging, and up to 120 hours of continuous use.

Paired with the Eko App, the stethoscope can record and save heart, lung and body sounds and run Eko's separately FDA-cleared AI for structural murmur detection, the company said. A murmur flagged by the software could lead to an echocardiogram or a specialist referral, HLTH reported.

Price and rollout

HIT Consultant and HLTH both reported a hardware price of $199. Access to the AI analysis requires an Eko+ subscription at $119.99 a year, which includes a 14-day trial, according to HLTH. Eko said in its release that the device is priced in line with premium traditional stethoscopes.

The company said it plans launches in Canada, the UK and select European markets. HIT Consultant reported that regulatory filings are under way in Asia-Pacific and Latin America.

"Our goal is to bring the most ubiquitous clinical exam into the precise digital era," Connor Landgraf, Eko's co-founder and chief executive, said in the release.

Evidence the company cites

Eko has pointed to TRICORDER, a study led by Imperial College London's Health Impact Lab and published in The Lancet, as evidence for its AI-enabled stethoscopes in primary care. In a January 2026 release, the company said the study covered 205 NHS general practices in the UK, about 1.5 million patients and nearly 1,000 clinicians who used Eko's AI stethoscopes in routine care. Over 12 months, detection of heart failure was 2.3 times higher, atrial fibrillation 3.5 times higher and valvular heart disease 1.9 times higher than with standard practice, according to the company's summary. Those results involved Eko's earlier devices, not CORE 300.

Eko said it has sold more than 750,000 devices worldwide. CORE 300 builds on the company's CORE 500 digital stethoscope and its Low Ejection Fraction Tool, introduced in 2024, according to HLTH.

Sources

  1. Eko Health Launches CORE 300 to Bring AI-Enabled Stethoscopes to Every Healthcare Professional, Eko Health, October 22, 2026
  2. 510(k) Premarket Notification K261694: CORE 300 Digital Stethoscope, US Food and Drug Administration, July 23, 2026
  3. Eko Health Launches CORE 300: FDA-Cleared AI Stethoscope, HIT Consultant, October 23, 2026
  4. The Lancet Publishes TRICORDER Study, Eko Health, January 29, 2026
  5. Eko Health launches FDA-cleared CORE 300 stethoscope with AI-assisted heart murmur detection, HLTH, October 23, 2026