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FDA clearance for Israeli Sanolla’s first AI-ready infrasound stethoscope

Sanolla Leading Team
Image credits: Sanolla

Sanolla, an Israeli startup that provides AI-powered primary care diagnostic solutions, has recently announced that the FDA has granted 510(k) clearance for the clinical use of the AI-ready VoqX. VoqX is the first smart and AI-ready stethoscope in the world that can listen to infrasound and acoustic waves that cannot be heard by humans.

The FDA clearance comes after the Israeli Health Ministry’s recently granted regulatory approval. The regulatory approvals will enable Sanolla to immediately make the VoqX available for clinical use in both the US and Israel, with the aim of replacing all of today’s archaic-technology stethoscopes with its smart infrasound stethoscopes.

“FDA clearance is an important milestone for Sanolla. The VoqX, which has been used extensively for studies in the United States, Europe and Israel, is now available for clinical use,” remarked Dr. Doron Adler, Sanolla’s co-founder and CEO. “Our distribution partners have been waiting for this moment to begin sales in the US and other territories.”

The world’s first acoustic stethoscope

Sanolla’s novel technology has been dubbed “The Sounds of Life”. The VoqX picks up clinically rich low-frequency sound waves (3-40Hz), also known as infrasound, which are not audible to the human ear yet carry diagnostic information beyond what is available in the audible spectrum only.

The VoqX’s smart signal processing works by shifting sounds to the ear’s most sensitive frequency range. Coupling this with dynamic noise cancellation provides an exceptional auscultation experience. Sanolla has also developed AI algorithms for disease classification that make full use of the infrasound information that’s uploaded to the AI-ready VoqX upon its regulatory clearance. Alongside the VoqX, the company has developed the PyXy home monitoring device for managing chronic diseases and early exacerbation detection for chronic cardiopulmonary diseases.

“The VoqX is an excellent tool for diagnosing cardiopulmonary morbidities including valvular pathologies. 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” exclaimed Dr Michael Wasserman, MD, a recognized geriatric care expert and a member of federal and state advisory committees.

Roots of the Medtech pioneer

Based in Nesher, Hefa, Israel and cofounded by David Linhard and Doron Adler in 2016, Sanolla has existed with the goal of providing smart infrasound-based diagnostics solutions for physicians and patient’s self-assessment.

To date, the startup has raised $16M, which includes $9M from the Founders, angels, and NextLeap Ventures, as well as  $7M from the European Union’s Horizon 2020 programme and the Israel Innovation Authority. The company is set to begin a series A funding raise this summer to cover sales, marketing, R&D, manufacturing and regulatory approvals.

Sanolla’s AI algorithms have provided unmatched disease classification for many cardiopulmonary diseases including COPD, asthma, pneumonia and cardiac morbidities. The company has also submitted 20 patent applications, 8 of which have already been granted; a significant achievement.

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