The Israeli startup company Sanolla has announced that its AI-ready stethoscope – the first in the world – has just received FDA approval.

The innovative stethoscope, VoqX, uniquely listens to infrasound acoustic waves to obtain lifesaving medical insights.

Not audible to the human ear, infrasound is made up of low-frequency soundwaves (3-40HZ) that can carry critical diagnostic information.

Extensive studies found that the startup’s AI algorithms provided advanced disease classification for diagnosing cardiopulmonary issues including COPD, pneumonia, asthma and others.

“FDA clearance is an important milestone for Sanolla,” said Dr. Doron Adler, Sanolla’s cofounder and CEO, adding that the company’s distributors “were waiting for this moment.”

The FDA’s clearance paves the way for Sanolla to provide the innovative stethoscope to clinics in the United States, Israel and other countries in the hope that VoqX eventually will replace standard stethoscopes.

Sanolla’s management team, from left: VP Business Development Jacob Bridger, cofounder and CEO Dr. Doron Adler, cofounder and COO David Linhard. Photo by Moran Maayan

Sanolla was established in 2016 by Adler and David Linhard, the COO. The startup has raised $416 million, including $7 million from the European Union’s Horizon 2020 Program and the Israel Innovation Authority, and has received eight patents.

In addition to the VoqX, the company has developed a home-monitoring device, PyXy, for chronic disease management and early detection of heart and lung diseases.