FDA OKs World’s First Infrasound Stethoscope in US

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by Steve Bryson PhD |

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The U.S. Food and Drug Administration (FDA) will allow Sanolla’s VoqX to be used in the clinic, the first stethoscope that can be used to detect infrasounds — acoustic waves that humans cannot hear.

The primary care stethoscope — a diagnostic tool clinicians normally use to listen to sounds of the heart, lungs, and other organs — is powered by artificial intelligence (AI) algorithms designed to improve the diagnosis and classification of diseases that affect the lungs, including chronic obstructive pulmonary disease (COPD).

The FDA’s clearance comes on the heels of the Israeli Health Ministry’s same regulatory approval, making it available in both countries to replace standard stethoscopes with infrasound ones.

“FDA clearance is an important milestone for Sanolla,” Doron Adler, PhD, Sanolla’s co-founder and CEO, said in a press release. “The VoqX, which has been used extensively for studies in the United States, Europe and Israel, is now available for clinical use.”

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“Our distribution partners have been waiting for this moment to begin sales in the U.S. and other territories,” Adler said.

Built on research demonstrating the medical importance of sounds in the body that humans cannot hear, the new technology, called “The Sounds of Life” detects infrasound — ultra low-frequency sound waves between 3 and 40 Hz. These sounds may be inaudible to humans, but they carry helpful diagnostic information.

Coupled with noise cancellation, VoqX’s signal processing shifts the infrasounds to a frequency range most sensitive to the human ear. AI algorithms have been developed and uploaded to the AI-ready VoqX to analyze infrasound information to help diagnose and classify COPD as well other lungs conditions, such as pneumonia or asthma, and heart problems, including heart valve defects.

“The VoqX is an excellent tool for diagnosing cardiopulmonary morbidities including valvular pathologies,” Michael Wasserman, MD, a recognized geriatric physician, said. “Its acoustic optimization and dynamic noise cancellation make the VoqX an indispensable tool for physicians in any environment and is expected to improve early detection of heart and lung diseases at the primary care level by general practitioners.”

The company has also developed PyXy, a home monitoring device for chronic disease management and early detection of exacerbations for chronic diseases affecting the lungs and heart.