More than 200 years ago, the invention of the stethoscope revolutionized healthcare by enabling the non-invasive diagnosis of heart and lung disease. Since then, this device has changed little, but the global cardiovascular disease burden has increased tremendously. Ischemic heart disease is now the leading cause of death in the world. In the U.S. alone, someone dies of heart disease every 34 seconds.
While treatments for cardiopulmonary disease have significantly advanced in effectiveness, early detection remains a challenge. It’s rare for clinically-significant heart disease to be diagnosed before symptoms present, even though initiating treatment early demonstrably improves outcomes and quality of life. Each year, there are an estimated 200,000 stroke and heart attack deaths in the U.S. that could have been prevented with timely medical interventions and lifestyle changes.
Until now, pre-symptomatic cardiopulmonary disease detection primarily relied on risk-based screening and auscultation during routine exams, methods with limited sensitivity and accuracy. One recent study of risk scoring found that 61% of patients who later had heart attacks were not flagged for further testing or preventative intervention under current risk-based screening guidelines. And auscultation’s effectiveness depends heavily on the performing clinician’s skill and experience. Findings are often inconsistent across care settings, and environmental noise can lead to missed detections.
For many patients, these limitations in screening protocols have meant that treatment won’t be initiated until their disease has progressed past the point when irreversible myocardial damage occurs, long-term survival rates decrease, and available treatment options are fewer and more invasive.
Today, advanced tools for detecting heart failure are helping doctors change this paradigm. Eko Health has created a new smart stethoscope that combines precision-engineered hardware, advanced sensors, software and AI-powered analytics to enable clinicians to distinguish healthy hearts from diseased ones with a degree of sensitivity that has hitherto been unimaginable without specialized imaging or echocardiography.
Reimagining the stethoscope as an AI-powered disease detection platform
Already used by more than 400,000 doctors and nurses around the world, devices like the Eko CORE 500™ Digital Stethoscope make it possible for clinicians to identify the structural murmurs associated with heart disease twice as often, compared to a traditional stethoscope.
“In heart disease detection, the sounds that clinicians are trained to listen for are very subtle,” says Karl Larson, Vice President of Supply Chain and Logistics Operations at Eko Health. “Auscultation is constrained by the limitations of the human ear, and it relies heavily on each individual doctor’s experience. Analog stethoscopes don’t have recording capabilities, so there’s no way of reviewing the sounds you’ve heard or sharing them with other clinicians.”
With a smart stethoscope, findings from every exam can be recorded and stored securely in the cloud. This makes it possible to track changes over time, share results with colleagues, or consult a specialist remotely. In addition, these devices can perform active noise cancellation and up to 40x sound amplification, enabling clinicians to hear more clearly and diagnose more confidently. Filters are also available to help listeners distinguish between cardiac, pulmonary and other body sounds, and the stethoscope’s audio output can be sent to Bluetooth devices like earbuds, portable speakers and select hearing aids for hands-free listening.
Smart stethoscopes can also measure heart rate and create three-lead ECG visualizations, which can be displayed on the device itself or sent to a tablet, mobile phone or laptop computer of the clinician’s choice.
While they’re listening, an FDA-cleared, AI-powered disease detection algorithm can analyze the heart sounds and EGC data in real time to identify structural murmurs, atrial fibrillation, low ejection fraction and other critical indicators of heart disease, displaying results in approximately 15 seconds.
Detecting cardiovascular disease earlier in real-world primary care settings
In both clinical trials and real-world care settings, AI-augmented auscultation with Eko digital stethoscopes has been proven to increase the detection of clinically significant cardiac disease. Findings from the largest randomized trial of AI-enabled stethoscopes to date, the TRICORDER study, were published in The Lancet in February 2026. The study, which followed nearly 1,000 primary care clinicians over 12 months, showed that those using digital stethoscopes in conjunction with AI disease detection algorithms detected 2.3x more heart failure, 3.5x more atrial fibrillation and 1.9x more ventricular heart disease (VHD) than baseline.
Another recently published study compared standard-of-care auscultation with an exam performed using an AI-enabled digital stethoscope during the same encounter. The researchers found that AI-enabled auscultation more than doubled the identification of moderate to severe VHD in comparison to the standard of care. The AI device flagged structural murmurs that were missed during the traditional stethoscope examination. Longer-term follow-up research showed that AI analysis of single-lead ECG data accurately predicted clinical outcomes, including major adverse cardiovascular events, over a two-year period.
Eko’s digital stethoscopes and AI algorithms have nearly a dozen FDA 510(k) clearances, covering the device hardware as well as the detection algorithms for standard murmurs, atrial fibrillation and low ejection fraction.
Empowering every healthcare worker in the world to detect heart disease at the level of an expert cardiologist
Eko’s AI-enabled digital stethoscopes were designed to be lightweight, easy-to-use and highly portable, Larson explains. “Imagine if every traveling doctor or nurse, everywhere in the world—in the desert, the jungle or other remote rural settings—could detect cardiopulmonary diseases with the accuracy of an expert cardiologist. That’s the vision that our team has followed.”
Realizing this vision—inside a device no larger or significantly heavier than a traditional stethoscope—demanded long battery life, powerful data processing capabilities and low power consumption. The stethoscope needed to incorporate two ultra-low-power digital microphones to deliver high-performance audio capabilities and noise cancellation and had to be able to send data to the cloud for processing.
How technology is changing the game for healthcare
The Eko engineering team designed a solution using Infineon components, leveraging the PSOC™ 63 Bluetooth® LE microcontroller and XENSIV digital PDM MEMS microphones to meet Eko’s performance, reliability and power efficiency targets. The ultra-low-power MCU, secured with PSOC™ 63 and using integrated Bluetooth® Low Energy (BLE) connectivity and CAPSENSE™ touch-sensing technology, enables the stethoscope to process digital signals intelligently in real time while using Bluetooth® to share data with local mobile devices and the cloud. The rare combination of capabilities—high-end processing, intelligent sensing and low power consumption—that the team found in the PSOC™ 63 Bluetooth® LE MCU helps make their digital stethoscope truly revolutionary.
“Our vision is to put smart stethoscopes around the neck of every doctor and nurse in the world,” says Larson. “We want to prevent disease progression and help patients live longer, healthier, better lives. We are working together with Infineon to shape the future of health tech.”
To learn more about Eko Health’s work, check out our latest case study on AI-powered precision heart disease detection.
