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Eko Health Launches CORE 300: FDA-Cleared AI Stethoscope Unifying Traditional and Digital Listening for Adult and Pediatric Care

Information You Need to Be Aware of. Eko Health, a company specializing in digital health and cardiovascular AI, has received FDA 510(k) clearance and is launching the CORE 300, an AI-powered stethoscope designed for both children and adults. This device boasts a dual-mode hardware innovation, as it is the first stethoscope to combine traditional analog acoustic listening and advanced digital listening modes in one chestpiece.

Clinicians can switch between these modes simply by twisting the chestpiece. Additionally, the CORE 300 can overcome ambient noise disturbances commonly found in busy clinical settings such as emergency departments, pediatric units, urgent cares, and rural skilled nursing facilities, thanks to its ability to amplify audio up to 35 times and its active noise cancellation feature.

Lastly, the device utilizes the TwistPower Architecture, which is a fusion of mechanical and digital technologies. In contrast to depending on inline tubing adapters or large electronic attachments, the CORE 0003 presents a unique chestpiece-binaural twist mechanism, enabling healthcare professionals to switch between listening methods effortlessly.

By turning the chestpiece, professionals can switch between traditional passive acoustic auscultation and digital listening. Even when the battery is dead, the passive method works. The stethoscope provides amplified sounds up to 35 times along with noise reduction in digital mode.

It also has filters for different types of assessments. There’s a display on the chestpiece that shows heart rates in real-time. The device is durable, comes with interchangeable parts, has Bluetooth connectivity, can be recharged via USB-C, and has a long battery life.

The product is set to be released commercially and expand internationally. Eko Health has announced its intention to introduce the CORE 300 globally in Canada, the UK, and certain EU countries. Meanwhile, the company is also working on submitting necessary documents for approval in Asia-Pacific and Latin America.

Eko is pricing its stethoscope at $199, using a consumer-friendly approach, and adding an annual software subscription fee ($119.99/year for Eko+), which transforms the stethoscope into a launching pad for recurring AI software income. Eko Health’s Co-founder and CEO, Connor Landgraf, described the company’s direction, stating that millions of healthcare professionals globally utilize stethoscopes daily for patient examinations.

We aim to introduce the extensively used clinical examination to the accurate digital age. When the physical examination goes digital, we integrate enhanced listening capabilities with precise measurements and clinical decision support system driven by artificial intelligence, all at the point of care.

 

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