What You Should Know
- Digital health and cardiovascular AI innovator Eko Health, the U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial rollout of CORE 300, an AI-enabled stethoscope designed for pediatric and adult populations.
- Introduces a dual-mode hardware innovation: CORE 300 is the first stethoscope to integrate traditional analog acoustic listening and advanced digital listening modes directly within a single chestpiece, allowing clinicians to toggle between acoustic and digital auscultation via a twist of the chestpiece.
- Overcomes ambient noise distractions in noisy clinical environments (busy emergency departments, pediatric units, urgent cares, and rural skilled nursing facilities) using up to 35x audio amplification paired with active noise cancellation (ANC).
Mechanical-to-Digital Hybrid: The TwistPower Architecture
Rather than relying on inline tubing adapters or bulky electronic add-ons, the CORE 300 introduces a proprietary chestpiece-binaural twist mechanism that allows clinicians to transition between listening modalities on the fly:
- Dual Physical & Digital Listening: With a simple mechanical twist of the chestpiece, clinicians can toggle instantly between familiar, unamplified passive acoustic auscultation—which continues to function even if the battery is fully drained—and active digital listening.
- Acoustic Filtering & 35x Amplification: In digital mode, the stethoscope delivers up to 35x sound amplification alongside active background noise cancellation (ANC), with selectable digital audio bandpass filters optimized for Cardiac, Pulmonary, or All-Purpose clinical assessments.
- On-Device Phonocardiogram Telemetry: Features an integrated, shatter-resistant monochromatic display built directly into the chestpiece, showing real-time, phonocardiogram (PCG)-calculated heart rates as the clinician listens.
- Shift-Resilient Hardware Specs: Weighing 5.3 oz (150 grams), the unit features interchangeable adult (45 mm) and pediatric (36 mm) diaphragms, Bluetooth Low Energy (BLE) connectivity, USB-C recharging, and an extended battery runtime delivering up to 120 hours of continuous clinical use (multi-week battery life under standard outpatient shifts).
Commercial Rollout & International Expansion
Eko Health confirmed plans to roll out the CORE 300 internationally across Canada, the United Kingdom, and select European Union markets, with additional regulatory filings underway across Asia-Pacific and Latin America. At $199, Eko is adopting a consumer-accessible hardware pricing model, paired with an annual software subscription ($119.99/year for Eko+), converting stethoscope hardware into an entry point for recurring AI software revenue.
Connor Landgraf, Co-founder and CEO of Eko Health, framed the platform’s trajectory: “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. Once the physical exam becomes digital, we combine better listening with objective measurements and AI-powered clinical decision support right at the point of care. Eko has delivered more than 750,000 devices, and CORE 300 is the next step toward bringing early disease detection confidence to every healthcare professional.”
