Sparrow wins FDA clearance for smartphone stethoscope

Sep 18, 2023

June 5, 2023 By Danielle Kirsh

Sparrow BioAcoustics today announced it received FDA 510(k) clearance for its software that turns smartphones into medical stethoscopes.

The downloadable Stethophone application uses advanced acoustic processing to provide clinicians with smartphones that have highly sensitive cardiac and pulmonary listening capabilities. It requires nothing to plug in, charge or connect, and heart and lung sounds are captured by 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," CEO Mark Attila Opauszky said in a news release. "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."

St. Johns, Newfoundland-based Sparrow BioAcoustics conducted trials at Eastern Health Medical Center in Newfoundland. 70% of medical professionals rated Stethophone superior in diagnostic sound performance over other leading devices, according to the company. The 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," Cofounder Yaroslav Shpak said in a news release. "Heart and lung sounds provide fast and exceptionally rich diagnostic information enabling early detection and quicker treatment."

Filed Under: 510(k), Business/Financial News, Cardiovascular, Diagnostics, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Sparrow BioAcoustics