California Company Eko Health Launches CORE 300 Hybrid AI Stethoscope
California company Eko Health officially launched the CORE 300 digital AI stethoscope on October 22, receiving FDA 510(k) approval (K261694), suitable for adult and pediatric patients.
This device is the first stethoscope to integrate traditional analog auscultation with digital amplification in a single chest piece. By rotating the chest piece, users can switch between traditional and digital modes. The digital mode supports up to 35x amplification, active noise cancellation, and three filters for heart, lung, and general use.
The back of the chest piece features a monochrome display that shows the patient's heart rate and AI screening results in real-time during auscultation. When paired with the Eko App on mobile, the system can mark potential structural heart murmurs within seconds. The AI functionality requires a subscription to Eko+, which comes with a 14-day free trial upon device purchase, followed by an annual fee of $119.99.
The official price is $199 (originally $249). The device has a clinical usage battery life of up to 120 hours, supports USB-C charging, and is equipped with a shatterproof display. The device is now available for purchase at ekohealth.com, with plans to expand to Canada, the UK, and parts of Europe.
Eko has previously sold over 750,000 devices and has multiple FDA-approved AI algorithms, including for murmur and low ejection fraction detection. The CORE 300 is positioned for routine check-ups, aiming to bring early detection of heart and lung diseases into more primary care settings.
In terms of market mechanism, the hardware is sold at a price close to traditional high-end stethoscopes, while AI capabilities are monetized through subscriptions. Medical institutions and individual practitioners purchase the hardware, and the software subscription provides ongoing monitoring and recording features. Traditional purely analog stethoscopes are under pressure in digital and AI-assisted scenarios, while Eko locks in future revenue through a hardware + subscription model.
Source: Public Information
ABAB AI Insight
Eko Health has long focused on early detection of heart and lung diseases, having previously launched several digital stethoscopes and received FDA approval for AI algorithms related to murmurs, atrial fibrillation, and low ejection fraction. The company has sold over 750,000 devices, building a foundation of clinical use and data. The CORE 300 continues this path by integrating analog and digital modes into a single chest piece.
From a capital perspective, the company opts for a low hardware entry price and monetizes AI functionality through subscriptions. The $199 price point is close to traditional high-end stethoscopes, lowering the procurement barrier; the Eko+ annual fee of $119.99 unlocks murmur detection, recording, and reporting features. This model transforms one-time hardware sales into ongoing software revenue while collecting clinical audio data through the app for algorithm iteration.
This approach is similar to AliveCor's hardware + subscription model in the ECG field or Butterfly Network's portable devices combined with cloud services in ultrasound. The current stethoscope market is still dominated by traditional analog products, but there is a rising demand for early screening in primary care, with AI-assisted auscultation penetrating from specialty to routine check-ups.
Essentially, this represents a reconstruction of diagnostic entry under technological substitution. Traditional auscultation relies on physician experience, while digitalization and AI transform subjective auscultation into recordable, taggable objective signals. The mechanism is that by upgrading the most common physical examination tool, more abnormalities can be captured during consultations, pushing detection from specialty to primary care, while locking in the value of subsequent data and services through subscriptions.
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