The US Food and Drug Administration has granted 510(k) clearance for the clinical use of the world's first AI-ready infrasound stethoscope, developed by Israeli medtech startup Sanolla, the company announced Monday.
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The VoqXTM from Sanolla, which produces artificial intelligence (AI)-powered primary care diagnostic solutions, is the first stethoscope in the world that can listen to acoustic waves that cannot be heard by humans.
Sanolla's novel technology, dubbed "The Sounds of Life," picks up clinically rich low-frequency sound waves (3-40Hz), also known as infrasound. The VoqX's smart signal processing shifts sounds to the ear's most sensitive frequency range.
The FDA clearance, which comes after Israel's own Health Ministry granted regulatory approval for the device, allows Sanolla to immediately make the VoqX available for clinical use in the US and Israel, with the aim of replacing all stethoscopes currently in use with its smart infrasound stethoscope.
Sanolla says that its AI algorithms provide "unmatched" disease classification for many cardiopulmonary diseases, including COPD, pneumonia, asthma, and cardiac morbidities. The company has submitted 20 patent applications, eight of which have already been granted.
"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," said Dr. Doron Adler, Sanolla co-founder and CEO. "Our distribution partners have been waiting for this moment to begin sales in the US and other territories."
Dr. Michael Wasserman, MD, a recognized expert on geriatric care and a member of federal and state advisory committees, said: "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."
Sanolla was established in 2016 by Adler and COO David Linhard. To date, the startup raised $16 million, which include $9 million from the founders, angels, and NextLeap Ventures and $7 million from the European Union's Horizon 2020 program and the Israel Innovation Authority. The company is set to begin a Series A fundraising raise this summer to cover sales, marketing, R&D, manufacturing collaborations and regulatory approvals.
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