Sanolla gets FDA clearance for VoqX

Israeli MedTech startup Sanolla, a company that provides AI-powered diagnostic solutions for primary care physicians, has received FDA 510(k) clearance for the clinical use of its device VoqX, the first and only stethoscope that can listen to infrasound, acoustic sound waves that aren’t detectable by the human ear.

The FDA clearance follows the regulatory approval recently granted by the Israeli Health Ministry. Approvals by the FDA (US Food and Drug Administration) and the health ministry enable Sanolla to make VoqX available for clinical use in the US and Israel immediately.

FDA clearance is an “important milestone” for Sanolla, Dr Doron Adler, CEO and co-founder, tells NoCamels in a phone interview, noting that the VoqX is “now ready for clinical use. ”

“This is the first and only stethoscope in the world that collects acoustic data from the body, analyzes the sounds, and presents its results on a monitor on a screen, which is integrated into the device,” he adds, “We have seen some activity from NASA to analyze these infrasounds — but I’m not aware of any company has commercial stethoscopes that do something like this.”

Founded in 2016 by Adler and David Linhard, the company’s current COO, Sanolla develops smart medical diagnosis andd patient monitoring solutions that listen to sounds of the body using patented AI-based infrasound technology. While the company has two other monitoring products, the VoqX smart stethoscope is the first one to receive FDA approval.

While there are several electronic stethoscopes that can be used as hearing aids where the volume can be amplified for the physician, Adler told Startup.info magazine in 2020, Sanolla is “the only company to use infrasound technology, to provide a comprehensive solution for professionals and home users as well and the only device which does not require a smartphone or internet connection nor cloud platform in order to have an answer as to whether or not to seek immediate medical intervention. The implications for rural populations and the elderly are staggering. The accessibility of our product is a differentiator allowing us to help more people easily from anywhere.”

Adler explains that the first step was to get the company’s smart stethoscope cleared by the FDA for clinical use and the next goal is to develop a stethoscope for remote care monitoring, where the patient won’t even have to leave the home.

“What we wanted to do was first get approval of the device itself as an electronic stethoscope and now we’re working on a validation process in diagnostic capabilities,” he says.

Infrasound refers to sound waves that are below the lower limit of what a human being can hear. With traditional devices, “it doesn’t matter how good the stethoscope is, the physician cannot hear those sounds or analyze them. And the body is made up of these sounds,” says Adler. Sanolla’s tech, dubbed “The Sounds of Life,” picks up low-frequency sound waves between 3 and 40 Hz, which can carry diagnostic information beyond what is available in the audible spectrum.

Adler describes the sound of a pounding heart as heard by a physician through a stethoscope.

“What you hear is something like b-boom. Two sounds they call S1 and S2. The first two relate to the sounds of the valves opening and closing during a cardiology cycle. But if you talk with a cardiologist, he will tell you that the heart actually generates four sounds, two of which are almost on the edge of audible. That’s S3 and S4. They relate to the behavior of the heart muscles when the blood hits the wall of the heart.”

Adler says cardiologists tend to use blood tests and other medical solutions to diagnose heart attacks, but those take precious minutes that the patient experiencing the myocardial infarction doesn’t have to spend. The infrasound stethoscope provides a better way to diagnose heart attacks and other conditions it can provide diagnosis and analysis analysis on a screen within seconds.

The VoqX stethoscope has a pickup unit that hears sounds not detectable to the human ear and then uses smart sensors and AI algorithms to take classify data taken from those sounds, saving time and money.

Sanolla’s AI algorithms also provide unmatched disease classification for many cardiopulmonary diseases, including cardiac morbidities, pneumonia, chronic obstructive pulmonary disease, and asthma, the company said.

“Physicians usually have a 50 or 60 percent detection for pneumonia,” says Adler, “Our stethoscope has been able to detect it at 85 to 95 percent.”

Going remote
The smart stethoscope has been used extensively for studies at the Mayo Clinic in the US and in Israeli hospitals like Tel Aviv’s Ichilov Medical Center, and Carmel Medical Center in Haifa. Adler’s next goal for the company is to make agreements with big medical suppliers in Israel like Clalit, Israel’s largest state-mandated health service organization and Maccabi, the country’s second-largest, before moving on to medical providers in Europe and the US.

According to Adler, Sanolla’s vision was to develop AI-powered product lines for healthcare professionals, hospitals, and clinics but also to create a remote healthcare product that can ai chronic patients and patients who have a hard time getting to the hospital. Adler tells NoCamels the company wants to “bring ability to the patient and in addition, allow the patient to monitor themselves, and treat themselves at home.” Most chronic patients and families could not access advanced heart and lung monitoring solutions from home until the Covid-19 pandemic accelerated the telemedicine industry, but many still have trouble.

“Now, after 200 years of traditional stethoscope use, our VoqX device can bring much better diagnostic abilities to physicians. We want to bring those abilities to patients at home who don’t really have a way to monitor themselves. The whole world is moving into remote patient monitoring.”

Alongside the VoqX, Sanolla has developed the PyXy home monitoring device for chronic disease management and early exacerbation detection for chronic cardiopulmonary diseases. They have also developed the SonoX, a smart pulmonary function test that provides 3D mapping of chest sounds, highlighting abnormalities, enabling fast and accurate triage in medical centers and rural places.

To date, Sanolla has raised $16 million, which include $9 million from the founders, angels, and NextLeap Ventures and $7 million from the European Union’s Horizon 2020 programme and the Israel Innovation Authority. The company is set to begin a Round A funding raise this summer to cover sales, marketing, R&D, manufacturing collaborations and regulatory approvals. NoCamels