FDA approves Israeli startup’s AI-enabled stethoscope

sounds that people cannot hear: The world’s first stethoscope capable of listening to infrasound – acoustic wavelengths that humans cannot hear, has received FDA granted 510(k) clearance for clinical use.

Sanolla, an Israeli startup that develops the AI-powered primary care diagnostic tools, said that FDA approval comes on the heels of the Israeli Health Ministry’s recent regulatory approval.

Sanolla may now make the VoqX available for clinical usage in the United States and Israel.

Sanolla’s artificial intelligence algorithms enable unequaled illness classification for a variety of cardiopulmonary conditions, including COPD, pneumonia, asthma, and cardiac morbidity. The company has filed a total of twenty patent applications, eight of which have been awarded.

Sanolla’s novel technology 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 stethoscope’s intelligent signal processing shifts sound to the most sensitive frequency range that people cannot hear of the ear, which, when combined with dynamic noise cancellation, creates an amazing auscultation experience.

Sanolla has created artificial intelligence (AI) algorithms for disease classification that make extensive use of the infrasound data that will be uploaded to the AI-ready VoqX upon regulatory authorization.

Along with the VoqX, the company created a home monitoring device (PyXy) for chronic illness management and early identification of chronic cardiopulmonary disorders exacerbations.

“The VoqX has been extensively used in research in the United States, Europe, and Israel and is now accessible for clinical usage,” stated Dr. Doron Adler, co-founder, and CEO of Sanolla.

Dr. Doron Adler (CEO) and David Linhard (COO) founded Sanolla in 2016. The startup has raised a total of $16 million to date, including $9 million from the founders, angel investors, and NextLeap Ventures, as well as $7 million from the European Union’s Horizon 2020 program and the Israel Innovation Authority.

This summer, the company plans to commence a Round A investment round to cover sales, marketing, research and development, manufacturing alliances, and regulatory permissions.

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

“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.”