FDA clears new AI-enabled stethoscopes that combine analog and digital listening
Eko Health has received U.S. Food and Drug Administration (FDA) clearance for Core 300, a new artificial intelligence (AI)-enabled stethoscope that offers both traditional analog and advanced digital listening capabilities.
The Core 300 stethoscopes give clinicians the ability to instantly switch from traditional listening to digital listening when evaluating both pediatric and adult patients. The technology behind Eko Health’s digital listening capabilities includes up to 35x amplification, noise cancellation and real-time heart data that is then displayed on the device.
These stethoscopes can also be connected to the Eko App or Eko’s FDA-cleared AI models for additional benefits. In addition, the battery life was designed to last for weeks at a time.
“Millions of healthcare professionals around the world use a stethoscope to examine patients every day,” Connor Landgraf, co-founder and CEO of Eko Health, said in a statement. “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.”
“Clinical technologies are evolving quickly, from smartphones at the point of care to AI entering the exam room, but adoption depends on making new capabilities fit naturally into the way clinicians already practice,” added Steven R. Steinhubl, MD, chief medical officer of Eko Health and a board-certified cardiologist who serves as a professor of biomedical engineering at Purdue University. “Core 300 bridges that gap. It preserves the traditional experience of auscultation while putting enhanced digital listening, objective measurements, and access to clinical decision support a twist of the chestpiece away. That combination can help make a smarter, more connected physical exam a routine part of care rather than the exception.”
The newly cleared device is also now available to U.S. consumers. A gradual international launch is also underway.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.