Israeli health startup Sanolla has received US Food and Drug Administration (FDA) 510(k) clearance for clinical use of its AI-ready VoqX infrasound stethoscope.

VoqX, the recipient of Israeli health ministry regulatory approval, is claimed to be the world’s first stethoscope that can listen to infrasound or acoustic sound waves that can’t be heard by the human ear.

With the approval, Sanolla can now launch the world’s first AI-ready VoqX infrasound stethoscope for clinical usage in the US and Israel.

Sanolla aims to make a transition from existing archaic-technology stethoscopes with its smart infrasound stethoscope.

VoqX is equipped with Sanolla’s AI algorithms for easy categorisation of a wide range of cardiopulmonary disorders such as COPD, pneumonia, asthma, and cardiac morbidities.

The startup named the technology “The Sounds of Life”, as it can pick up low-frequency sound waves (3-40Hz), which practically can’t be heard by human ears.

The smart signal processing technology transfers sound to the most sensitive frequency range of the ear to mix it with dynamic noise cancellation.

Sanolla co-founder and CEO Dr Doron Adler said: “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.

“Our distribution partners have been waiting for this moment to begin sales in the US and other territories.”

Sanolla has also created a PyXy home monitoring device for chronic illness management and early exacerbation identification in chronic cardiopulmonary disorders.

Geriatric care expert Dr Michael Wasserman 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.”

Till now, the firm has applied for 20 patents, eight of which have already been approved.