FDA Clears Sparrow’s Smartphone Stethoscope

Sparrow BioAcoustics has received clearance from the U.S. Food and Drug Administration (FDA) 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. With Stethophone, 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,” Sparrow BioAcoustics CEO Mark Attila Opauszky said. “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% of medical professionals rated Stethophone superior in diagnostic sound performance over other 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,” Sparrow BioAcoustics Co-Founder Yaroslav Shpak, M.D., stated. “Heart and lung sounds provide fast and exceptionally rich diagnostic information enabling early detection and quicker treatment.”

Sparrow’s Stethophone employs advanced acoustic processing and proprietary algorithms to make smartphones function as a stethoscope and FDA-cleared Class II medical device. 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.
 
Cardiovascular diseases (CVDs) are the leading cause of death globally, representing 32% 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.
 
Sparrow BioAcoustics, with offices in Newfoundland, Nova Scotia, and Toronto, is leading the software-as-a-medical device industry in new directions for cardiac and pulmonary detection and monitoring. Its team of physicians, engineers and data scientists are working to unlock the richest source of diagnostic information about cardiac and pulmonary conditions.