The stethoscope ranks as one of the most iconic instruments in medicine, and chances are it’s been a regular part of your health exams. Often used to measure heart and lung health, it’s essentially made of elongated tubes connected to a tiny disc or bell, and it allows doctors to listen for abnormal sounds and diagnose disease. Yet for more than 200 years, the basic structure and function of this simple instrument has remained pretty much the same.
But a start-up company called Eko Devices, Inc. has given the stethoscope a “smart” makeover by equipping it with digitized sound and artificial intelligence. These upgrades make it more efficient and effective at monitoring and diagnosing heart disease and other conditions that continue to occur at high rates worldwide. The Oakland, California company, which started in 2013, developed the device with funding support, in part, from the National, Heart, Lung, and Blood Institute (NHLBI) through its Small Business Innovation Research (SBIR) program.
Adam Saltman, M.D., Ph.D., the company’s chief medical officer, said the time had come.
“The traditional stethoscope has become almost a decorative piece, a badge of being a clinician,” he noted. But many new doctors are not so adept at using it, he said, so “its value has become increasingly questionable.” Indeed, he said, “it is in danger of becoming almost extinct.”
Saltman, a heart surgeon by training, explained that health-care providers who use stethoscopes have traditionally relied on auscultation, the process of listening to the sound of the heart, lungs, and other organs to make a diagnosis. But the skill has become somewhat of a lost art, he said. Some physicians today cannot effectively identify key sounds produced through the instrument, and that has meant more missed diagnoses. Saltman said his company wanted a tool that was more reliable, on its own, and that would catch missed diagnoses and help physicians make diagnoses earlier.
“We wanted to make the stethoscope smart, one that could listen to sounds and instantaneously tell a physician what the instrument heard – from heart murmurs to lung disease,” Saltman said.
He compared the upgraded device to AI systems like Alexa and Siri, which allow a person to instantly get answers to questions quickly, simply, and with little training – as does operating the smart stethoscope, said Saltman. Clinicians with varying skill levels, even patients themselves, can use it – and with this ease of access, he said, may come “the end of the stethoscope as we know it.”
The start-up company received FDA approval for its first digital stethoscope in 2015. Called the Eco Core, that device employed an add-on, tube-like accessory to an existing stethoscope that allowed sounds to be digitized. The sounds, which can be amplified 40 times their normal levels, can then be transmitted via Bluetooth to a cellphone and beamed thousands of miles away to a cloud platform or directly to an electronic tablet containing a patient’s medical records.
But the company didn’t stop there. In 2017, it developed the Eko Duo, a radical redesign that virtually eliminated the ear tubes that were part of the traditional stethoscope. The pocket-sized, FDA-approved device, which resembles a small cell phone, incorporates a pair of electrodes to produce an EKG tool with the sound-enhancement capabilities of the Eko Core stethoscope. Like a traditional stethoscope, the Eko Duo can be placed directly on the chest to detect sounds. But it also can produce a readout showing a graphic representation of both the sounds and the electrical signals produced by the heart—a boon for medical diagnostics.
The NHLBI became involved in the development of the Eko Core digital stethoscope in 2018 and has funded the company through multiple SBIR grants since that time. In particular, it funded an SBIR project aimed at using heart sounds recorded from the Eko Core digital stethoscope to develop a new AI algorithm that could help physicians identify aortic stenosis and other valvular heart diseases. Aortic stenosis is characterized by heart murmurs, and its subtle sounds can be difficult to detect using traditional auscultation. This can result in missed diagnoses and an undertreatment of the condition. The NHLBI hopes that the algorithm will enable more accurate screening for the condition, leading to earlier diagnosis and better patient outcomes.
“It’s great to see Eko’s digital stethoscope evolve into a new and improved instrument for detecting heart disease in a way that could potentially save lives,” said Stephanie M. Davis, Ph.D., NHLBI’s Small Business Program Coordinator. “The NHLBI SBIR program enthusiastically supports small companies in the development of better instruments to fight one of the leading causes of death in this country.”
Eko Devices is currently refining the algorithms in its artificial intelligence software to identify additional heart-related diseases. One focus is on detecting heart failure, one of the most difficult types of heart disease to spot – and also a serious condition that can lead to life-threatening complications. In the future, the company’s researchers hope to train their AI algorithm to quickly and accurately identify lung disease and vascular disease, including peripheral artery disease. Eko is one of a small but growing number of companies manufacturing digital stethoscopes today.
The company estimates that its stethoscopes are currently used by thousands of clinicians worldwide to monitor millions of patients, both in person and virtually. They note that interest in the devices as telehealth tools has increased during to the COVID-19 pandemic.
But it may be a while before smart stethoscopes become as commonplace as traditional stethoscopes: The use of artificial intelligence is still new in medicine and unproven when applied to the stethoscope world, said Saltman, who noted that more peer-reviewed, real-world testing of the devices is needed. Some of those studies are expected to begin soon at medical centers across the country, he said. “Our AI devices could potentially detect sounds better than physicians. And unlike doctors, AI doesn’t have bad days,” Saltman said. “If we can catch heart disease early, we can have a real impact on survival.”
More about the NHLBI SBIR and STTR programs
The NHLBI Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs support research and development on the next generation of commercially promising technologies and products to prevent, diagnose, and treat heart, lung, blood, and sleep-related diseases and disorders. For more information on NHLBI’s small business programs, visit http://www.nhlbi.nih.gov/research/funding/sbir/about-program
Reference to any specific commercial products, process, service, manufacturer, and/or company does not constitute an endorsement or recommendation by the National Heart, Lung, and Blood Institute (NHLBI), the NHLBI's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, or any other portion of the U.S. Government.