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World’s First AI-Ready Infrasound Stethoscope Gets FDA Approval


By Diana Bletter

Israeli startup Sanolla announced its AI-ready stethoscope — the first of its kind in the world — has achieved a major regulatory milestone: It’s been approved for use by the U.S. Food and Drug Administration.

The innovative stethoscope, VoqX, 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 the startup’s AI algorithms provided advanced disease classification for diagnosing various cardiopulmonary issues, including COPD, pneumonia and asthma.

“FDA clearance is an important milestone for Sanolla,” said Dr. Doron Adler, Sanolla’s co-founder-CEO, adding 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 replaces standard stethoscopes.

Sanolla’s VoqX stethoscope picks up sounds the human ear normally can’t hear. (Tiko Product Design Studio)

Recent studies demonstrate that COVID-19 patients present “silent hypoxemia” that might be a projection of silent pneumonia. Sanolla’s products can identify and classify the full lung sound spectrum, including the infrasound range.

Recently, Sanolla led a consortium for the PyXy.AI project, under the Horizon 2020 program to fight COVID-19 and monitor lung and heart chronic patients. In a multi-center clinical trial, the company’s site reported, it collected 3,290 lung-sound files from 217 COVID-19 patients and 2,016 lung sound files from 144 healthy subjects. These files were sampled with the intent to develop an AI-powered classifier for COVID-19.

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. It has also received eight patents and offers three products: VoqX, PyXy and SonoX.

Sanolla’s three products help with disease detection and chronic disease management. (Sanolla)

The home-monitoring device PyXy is also helpful with early detection of heart and lung diseases. It gives patients piece of mind in their homes. It indicates their clinical condition on the device display, which is especially useful for families, the elderly and any quarantined or immobilized patient.

Pyxy is expected to be commercialized in under two years. By connecting clinicians and patients remotely, healthcare would become more immediate.

A third product is SonoX, a tool in chest functionality estimation that identifies chest sounds, including infrasound spectrum, and uses deep learning classification to detect clinical abnormalities. SonoX maps sound sources to a physical 3D lung simulator highlighting irregularities. It can facilitate speedy triage; reduce exposure to radiation from X-rays and CT; and minimize blood-test exams.

Produced in association with ISRAEL21c.

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