Israel-based AI-powered primary care startup Sanolla reported on Monday the receipt of US FDA 510(k) clearance for the clinical use of the AI-ready VoqX, the first stethoscope in the world that can listen to infrasound - acoustic waves that cannot be heard by humans.

The company said the US FDA clearance follows the Israeli Health Ministry's recently granted regulatory approval.

Effective immediately, the company said VoqX will be available for clinical use in the US and Israel, with the aim of replacing all of the archaic-technology stethoscopes with its smart infrasound stethoscope.

The company's AI algorithms provide unmatched disease classification for many cardiopulmonary diseases including COPD, pneumonia, asthma, and cardiac morbidities. It has submitted 20 patent applications, eight of which have already been granted.

According to the company, its novel technology, called "The Sounds of Life", picks up clinically rich low-frequency sound waves (3-40Hz), which are not audible to the human ear yet carry diagnostic information beyond what is available in the audible spectrum only. Its AI algorithms for disease classification make full use of the infrasound information that will be uploaded to the AI-ready VoqX.