Startup Sanolla Manshar, which provides artificial intelligence-based diagnostic solutions for primary care, has announced that the US FDA has approved 510 (k) approval for clinical use of VoqX, the world’s first smart stethoscope that detects infrared sound – sound waves That the human ear is unable to hear. FDA approval is given after the company has also received an approval from the Ministry of Health in Israel. These approvals allow the start of sales of VoqX קלי for clinical use in the US and Israel with the company’s goal being to replace all state-of-the-art stethoscopes with the new smart stethoscopes.
The Snola stethoscope is ready to implement artificial intelligence algorithms, developed by Snola, that will provide an unprecedented ability to classify cardio-pulmonary diseases including chronic obstructive pulmonary disease (COPD), pneumonia, asthma and heart disease. The product also opens the door to diagnose heart-lung diseases that could not, until today, be diagnosed by listening. The company filed 20 patent applications, 8 of which have already been approved.
Snola’s innovative technology, known as the “sounds of life”, picks up low-frequency sound waves (3-40Hz), known as infrared sound. These sound waves are not absorbed by the human ear but contain a great deal of clinical information that until now was not accessible to the medical community.
VoqX’s smart signal processing technology optimizes body sounds to the human ear and together with dynamic noise cancellation technology it delivers an exceptional listening experience. Snola has developed artificial intelligence (AI) algorithms to classify diseases that will fully process the information contained in infrared sounds. These algorithms will be integrated in VoqX ™ after receiving regulatory approval.
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In addition to VoqX ס, Snola has developed PyXy ™, a home monitoring device for monitoring chronic diseases and for early detection of exacerbations of heart and lung diseases.
“FDA approval is an important milestone for Sanolla. VoqX, which has been widely used in studies in the United States, Europe and Israel, is immediately available for clinical use,” said Dr. Doron Adler, CEO and co-founder Sanolla. “Our distributors have been waiting for this moment to start sales in the US and other countries.”
Dr. Michael Wasserman, a renowned physician in the field of geriatric care and a member of the Advisory Committee to the Federal Government: “VoqX ™ is an excellent diagnostic tool for heart and lung diseases including valve problems. “Its voice optimization and dynamic noise cancellation make it an essential tool for physicians in any environment and it is expected to improve the early detection ability of heart and lung diseases by GPs and primary care physicians.”
Snola was founded in 2016 by Dr. Doron Adler (CEO) and David Linhard (COO). To date, the company has raised $ 16 million: from founders, private investors, the NextLeap Ventures fund, the EU’s Horizon 2020 program and the Innovation Authority. The company plans to enter the A round of recruitment in the coming months in order to accelerate its marketing, sales, regulatory, and further development efforts.