The startup Sanolla has won 510(k) clearance for the clinical use of the VoqX stethoscope. The device is reportedly the first to capture infrasound, which is below the range of human audibility. The infrasound spectrum of 3–40Hz contains diagnostic information overlooked by traditional stethoscopes.
The technology recently won approval from the Israeli Health Ministry.
The Nesher, Israel–based startup has developed AI algorithms for the stethoscope that can classify common cardiopulmonary diseases such as COPD, pneumonia, asthma and cardiac morbidities.
The device has won eight patents to date. To date, the company has submitted 20 patents for the stethoscope technology.
The company also seeks regulatory authorization for VoqX-based AI algorithms for disease classification. The algorithms will be uploaded to the device after regulatory authorization.
Sanolla said the stethoscope could cut the need for CT or X-ray radiation and for invasive blood tests.
The VoqX stethoscope simultaneously captures heart rate, oxygen level, body temperature and respiratory cycle.
The VoqX amplifies the chest sounds by a factor of 30 and provides external noise reduction. It also supports recording and data transmission.
Founded in 2016, Sanolla has raised $16 million to date.