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FDA clears Sparrow’s Smartphone Stethoscope for use by medical professionals

Press releases may be edited for formatting or style | June 05, 2023 Endoscopy Health IT
ST. JOHN’S, Newfoundland--(BUSINESS WIRE)--Sparrow BioAcoustics today announced it has received clearance from the U.S. Food and Drug Administration to market its software that allows smartphones to be used as medical stethoscopes.

The downloadable Stethophone™ application uses advanced acoustic processing to provide smartphones with highly sensitive cardiac and pulmonary listening capability. Stethophone is unique in that there is nothing new to plug in, charge, or connect. Heart and lung sounds are captured by simply holding a smartphone to a patient’s chest without the need to attach any additional devices.

“Our goal is to enable large-scale, rapid detection of cardiac and pulmonary symptoms, wherever they occur,” said Mark Attila Opauszky, CEO of Sparrow BioAcoustics. “There is a world of diagnostic information contained in chest sounds, and the healthcare system needs a practical way to capture this data and put it to work for the benefit of patients. Stethophone eliminates the main obstacles to doing that.”

In trials conducted at Eastern Health Medical Centre of Newfoundland, 70 percent of medical professionals rated Stethophone superior in diagnostic sound performance over other leading devices. Stethophone also performed significantly higher in overall correct heart pathology diagnosis and correct normal heart diagnosis.

“Stethophone captures gallops, murmurs and arrythmias indicative of numerous progressive cardiac diseases.” said Yaroslav Shpak, M.D., co-founder of Sparrow BioAcoustics. “Heart and lung sounds provide fast and exceptionally rich diagnostic information enabling early detection and quicker treatment”

Cardiovascular diseases (CVDs) are the leading cause of death globally, representing 32 percent of all global deaths. The number of people at risk of CVD is on the rise. The American heart association reports that nearly half of all U.S. adults have some type of cardiovascular disease.


About Sparrow BioAcoustics
Sparrow BioAcoustics, with offices in Newfoundland, Nova Scotia and Toronto, Canada, is leading the Software as a Medical Device industry in new directions for cardiac and pulmonary detection and monitoring. Our team of physicians, engineers and data scientists are working to unlock the richest source of diagnostic information about cardiac and pulmonary conditions. Our mission is to help the millions of people at-risk and suffering from cardiac and respiratory disease to live longer, healthier lives enabled by earlier detection and quicker treatment.


About the Stethophone
Sparrow’s Stethophone employs advanced acoustic processing and proprietary algorithms to make smartphones function as class-leading stethoscope and FDA-cleared Class II medical devices. Only Stethophone is able to distill accurate heart and lungs sounds using a smartphone’s internal microphone. Stethophone captures and helps analyze this diagnostically-rich data and makes it securely shareable with other members of the care team. Stethophone makes it possible to gain insight into the structural condition of the heart and lungs, wherever and whenever a patient experiences symptoms.

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