Eko Health began U.S. sales of the CORE 300 on 22 October 2026, a stethoscope the company describes as the first to put traditional analog listening and FDA-cleared digital listening in a single chestpiece. A clinician twists the chestpiece to move between analog mode and three digital modes — Cardiac, Pulmonary and All Purpose — and Eko's AI software, cleared separately from the hardware itself, flags possible structural heart murmurs from what it hears.
A stethoscope company's thirteenth year
From a UC Berkeley dorm room to a dual-mode chestpiece
- 2013
Eko founded
Connor Landgraf, Jason Bellet and Tyler Crouch start the company at UC Berkeley to digitize the stethoscope exam.
- 2015
First FDA clearance
FDA 510(k) clearance (K151319) for the original CORE, a digital attachment that clips onto an analog stethoscope.
- 2017
DUO cleared
FDA 510(k) clearance (K170874) for the DUO, combining digital stethoscope listening with a single-lead ECG.
- November 2020
$65 million Series C
Led by Highland Capital Partners and Questa Capital, to expand telehealth and AI screening tools.
- 2023
CORE 500 launched
Flagship digital-only stethoscope adds a 3-lead ECG, a full-color display and Sensora, Eko's heart-sound AI platform.
- June 2024
$41 million Series D
Brings total funding to more than $165 million, earmarked to scale AI-driven heart and lung disease detection.
- 23 July 2026
CORE 300 cleared
FDA 510(k) clearance (K261694) for the CORE 300 hardware, with its EFAST AI murmur-detection software cleared separately (K251494).
- 22 October 2026
CORE 300 launches
U.S. commercial availability begins, more than 750,000 Eko devices into the company's history, per Eko's own count.
- Ahead
Canada, UK and EU markets
Eko says it expects to bring the CORE 300 to Canada, the United Kingdom and select European markets next.
The CORE 300 in four figures
Figures from Eko Health's 22 October 2026 launch announcement.
One chestpiece, a twist between two exams
The mechanical stethoscope has barely changed since René Laennec rolled a sheet of paper into a cone in 1816. Eko Health has spent thirteen years trying to change it incrementally: a clip-on attachment in 2015, a single-lead ECG combination in 2017, a flagship digital-only device with a 3-lead ECG in 2023. The CORE 300 is a different move — rather than replace the analog exam, it keeps it, adding digital listening as a twist of the chestpiece rather than a separate purchase. Connor Landgraf, Eko's co-founder and CEO, framed the goal in the launch announcement: “Our goal is to bring the most ubiquitous clinical exam into the precise digital era.”
“Millions of healthcare professionals around the world use a stethoscope to examine patients every day. Our goal is to bring the most ubiquitous clinical exam into the precise digital era.” Connor Landgraf, Co-Founder and CEO, Eko Health — 22 October 2026 launch announcement
FDA cleared the CORE 300 hardware on 23 July 2026 under 510(k) K261694, per Eko's own regulatory disclosures; the AI software behind its structural-murmur detection, branded EFAST (Eko Foundation Analysis Software with Transformers), holds a separate clearance, K251494. The roughly three-month gap between hardware clearance and the 22 October commercial launch is not unusual for a device that depends on a companion AI subscription service reaching general availability alongside it.
Three things that separate the CORE 300 from a point upgrade
Analog stays, digital is added
A clinician who distrusts a fully digital exam keeps the option they already trust; the CORE 300 does not force a choice between the two, unlike a device built as digital-only from the start.
AI detection, not just amplification
The EFAST software's separate FDA clearance (K251494) means the murmur-flagging claim rests on its own regulatory review, not a marketing layer on top of louder sound.
One device, two populations
Eko's launch materials describe the CORE 300 as built for both adult and pediatric care, extending a single hardware platform across the exam types a primary-care or pediatric practice actually runs.
A crowded chestpiece, not an empty one
Eko is not alone in selling an amplified or digital stethoscope. 3M's Littmann CORE Digital Stethoscope, now sold under the Solventum brand after 3M spun off its health care business, claims up to 40x amplification with active noise cancellation and a toggle between analog and amplified modes — and, notably, pairs with Eko's own software on iOS and Android under some retail listings. Thinklabs' One takes the opposite design choice: no analog mode at all, more than 100x amplification through dedicated per-channel headphone amplifiers, and a standard 3.5mm jack for any headphones, at a lower list price than the CORE 300.
CORE 300 against the stethoscopes it competes with
| Product | Listening modes | Amplification | Built-in AI detection | List price |
|---|---|---|---|---|
| CORE 300 (Eko Health) | Analog + 3 digital modes, one chestpiece | Up to 35x | Yes (EFAST, K251494) | $199 + Eko+ subscription |
| Littmann CORE (Solventum) | Analog + amplified, toggle | Up to 40x | Via Eko-powered software | Varies by retailer |
| Thinklabs One | Digital only, no analog mode | 100x+ | No | $499–$599, per retailer |
From each company's published specifications and retail listings; not a clinical comparison.
What a digitized exam is worth
Published forecasts for the digital stethoscope market disagree sharply, largely because publishers draw the category's boundary differently — some count only hardware, others fold in AI-enabled software and services. The spread is wide enough that it says more about how early the category still is than about any one number being right.
Digital stethoscopes, two publishers apart
$726.5M → $1.56B
Global digital stethoscope market, 2024 to 2033, as forecast by Dataintelo (2026), shown against Fairfield Market Research's considerably narrower 2033 estimate for a more tightly scoped definition of the category.
Sources: Dataintelo, Digital Stethoscope Market Research Report 2033 · Fairfield Market Research, Digital Stethoscope Market Insights 2033
Regulatory News outlook
We expect the AI-enabled segment of this market, where Eko already holds multiple FDA clearances, to grow faster than hardware-only digital stethoscope sales, since a recurring AI subscription like Eko+ captures revenue a one-time device sale alone does not.
How we got here: Dataintelo's $726.5M 2024 base compounded at its stated 8.9% CAGR reaches roughly $1.56B by 2033, matching its published figure; we treat Fairfield's far narrower $158M 2033 estimate, built on a 6.3% CAGR from a smaller 2026 base, as evidence the category's addressable market remains a matter of definition, not yet a settled figure either publisher's number resolves.
The subscription behind the hardware
Eko has not published clinical outcomes data specific to the CORE 300's structural-murmur detection feature tied to this launch, beyond the device's underlying FDA clearance. The company's international rollout plans for Canada, the UK and parts of Europe carry no announced dates. And the CORE 300's reliance on an annual Eko+ subscription for its AI features means its real-world adoption will depend as much on recurring-revenue economics for buyers as on the hardware itself.
- Hardware clearance: FDA 510(k) K261694, dated 23 July 2026.
- AI clearance: EFAST structural-murmur detection software, FDA 510(k) K251494.
- U.S. launch: 22 October 2026, priced at $199 plus a $119.99/year Eko+ subscription after a 14-day trial.
- International rollout: Canada, the UK and select European markets planned next, with no dates announced.
Sources & further reading
- Eko Health, “Eko Health Launches CORE 300™ to Bring AI-Enabled Stethoscopes to Every Healthcare Professional,” press release, 22 October 2026. prnewswire.com
- “Eko Health Launches FDA-Cleared CORE 300 Stethoscope with AI-Assisted Heart Murmur Detection,” HLTH Insights, October 2026. hlth.com
- “Eko Health launches AI-enabled stethoscope,” MobiHealthNews, October 2026. mobihealthnews.com
- “FDA clears new AI-enabled stethoscopes that combine analog and digital listening,” Cardiovascular Business, October 2026. cardiovascularbusiness.com
- Eko Health, CORE 300 product page. ekohealth.com
- Eko Health, “Eko Raises $65 Million in Series C Funding,” press release, 9 November 2020. businesswire.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What is the CORE 300?
A digital stethoscope that toggles between traditional analog listening and three FDA-cleared digital modes (Cardiac, Pulmonary, All Purpose) in a single chestpiece, with up to 35x amplification, active noise cancellation, a built-in heart-rate display and AI-assisted structural murmur detection through Eko's EFAST software. It launched in the United States on 22 October 2026 at $199, with AI analysis requiring an Eko+ subscription at $119.99 a year after a 14-day trial.
When was the CORE 300 cleared by FDA?
FDA cleared the CORE 300 hardware under 510(k) K261694 on 23 July 2026, roughly three months before its 22 October 2026 commercial launch. Its AI murmur-detection software, EFAST, holds a separate clearance, K251494.
Is Eko Health a public company?
No. Eko Health is privately held, backed by venture investors including Highland Capital Partners, Questa Capital and ARTIS Ventures, having raised more than $165 million across funding rounds including a $41 million Series D in June 2024.
Is the CORE 300 approved for children?
Eko Health describes the CORE 300 as cleared for both adult and pediatric care in its launch materials; this article has not independently reviewed the device's FDA-cleared labeling for the specific pediatric age range covered.
