Israeli startup Sanolla, which provides AI-powered primary care diagnostic solutions, announced that the FDA has granted 510(k) clearance for the clinical use of the AI-ready VoqXTM, the first stethoscope in the world that can listen to infrasound – acoustic waves that cannot be heard by humans. The FDA clearance follows the Israeli Health Ministry’s recently granted regulatory approval. The regulatory approvals enable Sanolla to immediately make the VoqX available for clinical use in the US and Israel, with the aim of replacing all of today’s archaic-technology stethoscopes with its smart infrasound stethoscope.
Sanolla’s AI algorithms provide unmatched disease classification for many cardiopulmonary diseases including COPD, pneumonia, asthma, and cardiac morbidities. The company has submitted 20 patent applications, 8 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’s co-founder and CEO. “Our distribution partners have been waiting for this moment to begin sales in the US and other territories.”
Sanolla’s novel technology, dubbed “The Sounds of Life”, 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 shifts sounds to the ear’s most sensitive frequency range and coupled with dynamic noise cancelation provides an exceptional auscultation experience. Sanolla has developed AI algorithms for disease classification that make full use of the infrasound information that will be uploaded to the AI-ready VoqX upon their regulatory clearance. Alongside the VoqX, the company has developed the PyXy™ home monitoring device for chronic disease management and early exacerbation detection for chronic cardiopulmonary diseases.
Sanolla was established in 2016 by Dr. Doron Adler (CEO) and David Linhard (COO). 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 programme and the Israel Innovation Authority. The company is set to begin a Round A funding raise this summer to cover sales, marketing, R&D, manufacturing collaborations and regulatory approvals.
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”.