FDA approves Sparrow smartphone stethoscope 2023

The Food and Drug Administration (FDA) has granted Sparrow BioAcoustics (Sparrow) approval for its smartphone stethoscope.

The Breakthrough Software as a Medical Device (SaaMD) approval has been granted for the Stethophone software, which permits the use of smartphones as medical stethoscopes.

Using sophisticated acoustic processing, the downloadable Stethophone application provides smartphone users with sensitive cardiac and pulmonary listening capabilities.

A smartphone can capture heart and pulmonary sounds by being placed on a patient’s thorax.

Stethoscopes can be used to record, analyze, and share information pertaining to cardiovascular and pulmonary sounds.

Mark Attila Opauszky, CEO of Sparrow BioAcoustics, stated, “Our mission is to enable rapid, large-scale detection of cardiac and pulmonary symptoms wherever they occur.

“Chest sounds contain a wealth of diagnostic information, and the healthcare system requires a practical method to acquire and utilize this data for the benefit of patients. The stethoscope eliminates the primary barriers to doing so.”

In trials conducted at the Eastern Health Medical Centre of Newfoundland, 70% of medical personnel rated Stethophone as having superior diagnostic sound performance compared to other devices, as reported by the company.

In addition, Stethophone performed substantially better in correctly diagnosing heart pathologies and normal heart conditions.

Dr. Yaroslav Shpak, co-founder of Sparrow BioAcoustics, stated, “Stethophone captures gallops, murmurs, and arrhythmias that are indicative of many progressive cardiac disorders.

“Heart and lung sounds provide exceptionally rich and rapid diagnostic information, allowing for earlier detection and treatment”

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