The US Food and Drug Administration (FDA) has granted 510(k) clearance for the clinical use of Sanolla’s AI-ready VoqX infrasound stethoscope.
VoqX detects infrasound and audible sounds to identify clinical conditions, displaying diagnosis through the company’s sound signature image.
It is claimed to be the world’s first stethoscope that can listen to infrasound or acoustic waves that humans cannot hear.
Recently, the device received regulatory approval from the Israeli Health Ministry.
With the approvals, the company will make the new infrasound stethoscope available for clinical use in Israel and the US immediately.
Sanolla aims to replace all existing archaic-technology stethoscopes with its new smart infrasound stethoscope.
The new technology, named ‘The Sounds of Life’, picks up low-frequency sound waves (3Hz-40Hz), also known as infrasound, which cannot be heard by human ears.
The smart signal processing technology of the device transfers sounds to the most sensitive frequency range of the ear.
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.”
The company has also developed the PyXy home monitoring device for managing chronic illness and early exacerbation detection for chronic cardiopulmonary diseases.
Sanolla’s artificial intelligence (AI) algorithms provide unmatched disease classification of several cardiopulmonary diseases, such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia and cardiac morbidities.
Established in 2016, Sanolla has raised $16m to date and is set to commence Round A funding to cover marketing, sales, R&D, manufacturing partnerships and regulatory approvals.