ProWhen Prof. Shmuel Banai, head of the cardiology department at Ichilov Hospital, examines a patient, he uses not only known standard means. At some point in the examination, Prof. Banai uses a new type of stethoscope capable of detecting body sounds that the human ear does not hear. It is used similarly to a standard stethoscope, and the examination lasts only a few seconds. The system listens to several points in the patient’s body, collects the data, and processes them with the help of artificial intelligence technology. Within a few seconds of completing the test, it displays several results, including heart rate and respiratory cycle, as well as an assessment of possible disease.
The VoqX stethoscope is being developed by Sanolla. Prof. Banai serves as medical director of the company. "VoqX ‘hears’ sounds that even the ear of the most skilled cardiologist cannot," he explains. "It recognizes both sounds that the ear can pick up and those that it cannot, and makes an integration that allows it to distinguish between normal and abnormal conditions, and to identify specific problems, such as a leak or stenosis in a heart valve, and even its severity. At this point, the cardiologist can decide what to do and refer the patient to further tests at the hospital. It saves a great deal of time and money. The skills and listening abilities of doctors in the community are limited, therefore they tend to refer patients to complicated and expensive tests at the hospital, such as cardiac ultrasound and CT. The tool we make available to doctors in the community enables them to determine whether there is a problem and what its source is, without having to refer the patient to other specialists. It’s a huge upgrade.”
"In Israel, there is a lot of talk about the gaps in the quality of medicine between the center and the periphery, but the periphery is not necessarily a geographic location," he adds. "In addition to cardiologists in less populated areas in the north or south, who lack some of the more advanced technological tools, there are also all the family doctors who see patients in their clinics in the center of the country, who lack a tool that can reveal the patient's problems during the examination. With its simple operation and clear data presentation, VoqX closes this gap. It also allows patients who do not reside in the center to obtain the diagnosis without having to travel to remote hospitals. This is an advantage of particular significance in countries like the US, where it is not uncommon to travel for two hours to see a specialist."
Listen to all activity in the body
"We have developed a device that allows accurate and rapid diagnosis without the need for advanced technologies that are available only in large hospital departments, and without the need for advanced expertise in cardiology," says Dr. Doron Adler, CEO and founder of Sanolla. "VoqX greatly upgrades the attending physician's diagnostic abilities and saves the patient a great deal of hassle in hospitals. It shortens the process the patient undergoes until a diagnosis is reached, and brings it within the reach of the physician in the community. Even a nurse in a nursing home will be able to operate the device. VoqX can detect whether lung function is normal, and if not, what is wrong: fluid congestion, pulmonary edema, pneumonia. It can even distinguish between asthma and lung damage due to the coronavirus. It is possible to use VoqX to listen to the activity of the entire body, including movements that do not produce sound, like those of the joints. In the future, we may be able to hear the sound of worn-out cartilage and other indications that have sound signatures. VoqX can even detect the movement of a fetus in the amniotic fluid in the uterus."
“You mentioned corona. Has VoqX been used already to identify corona patients?”
"Yes. The device listens to sounds, processes them, and within seconds produces an assessment of whether the person has COVID-19, and if yes, how severe the disease is. One of the challenges the coronavirus presented was to differentiate between normal pneumonia and pneumonia due to COVID-19. It turned out that in corona patients the inflammation is not in the lung itself, but in the tissue that surrounds it. The sounds the disease makes are different and can be heard distinctly. Thus, the product can identify and classify cardiac insufficiency and chronic pulmonary diseases. Today these conditions can be identified only by a physician at the clinic or in the emergency room. We will make it possible for a doctor to identify them already in the community or a home examination."
Obtaining critical medical identification early
In developing VoqX, the researchers at Salona were guided by the understanding that the techniques of listening to sounds generated by the body needed a significant upgrade. The sounds of the human body that can be heard by the naked ear are partial, and the older the physicians become the less they hear. We knew that it was possible to obtain more extensive sound information than is currently available. "It seemed absurd to us that such important clinical information exists, but it is not used by the medical community, although it is so effective and saves invasive testing," Dr. Adler notes. “In the past, only NASA dealt with infrasound research. Yet medicine can make extensive use of this technology. VoqX uses it to test and diagnose a long list of parameters: vital signs, heart rate and electrical signals emitted by the heart, blood oxygen level, respiratory cycle and its character, even body temperature. The device can reach conclusions that until now required performing an ECG or a blood test. In the home of a person who feels tightness in the chest, an ambulance crew can use the device and detect a heart attack with 90% accuracy. Pneumonia can be detected in 92% of the cases, without the need for an X-ray examination. A physician with a standard stethoscope detects only 50%-60% of cases."
"The importance of the device lies not only in diagnosing disease but also in identifying healthy conditions," adds Prof. Banai. "It is important to make sure that even if you hear a murmur in the heart, it has no medical significance and there is no need to refer the patient for further tests at the hospital. Using artificial intelligence, and based on many instances that the system learns from healthy and pathological conditions, it can identify and separate normal conditions from abnormal ones. At Ichilov Hospital, we collect a lot of data about patients who undergo sophisticated cardiac tests. We listen to their bodies with VoqX and teach the system how a normal heart sounds and what sounds are emitted by the heart in various pathological cases. Mathematical models of big data make such learning possible, and eventually the system can analyze the data itself and display on the stethoscope a record of the sounds produced by the heart, and an interpretation of these sounds."
Dr. Adler: “The results of the artificial intelligence system are excellent, much better than what we estimated when we set up the company. Today we achieve over 90% accuracy in samples of hundreds of subjects. Beyond the convenience and other benefits mentioned, VoqX makes it possible to identify medical issues that until now have been particularly challenging. For example, less than one-third of asymptomatic heart disease is being detected today, and some studies claim that it is less than a quarter. If it is not identified and treated in time, the medical condition only gets worse and its treatment becomes much costlier for the health system. This is why early detection is so critical. If today only 25% are detected during the stages when it is important to make the diagnosis, and we identify over 90%, it means that millions of people around the world will be able to obtain a critical medical diagnosis in time to start treatment in the early stages of the disease. Identifying a worsening condition is another important goal. There are tens of millions of patients worldwide whose treatment would be simpler if their worsening condition were detected in time. Patients’ quality of life will improve and the health systems will save a lot of money."
Giant companies are interested in the device
VoqX is not yet in regular use. The product is in the alpha stage of development, when only a few physicians use it. They challenge the system during their practice and continue to teach it by listening to the patients’ bodies. In cases when developers are not satisfied with the level of accuracy, they continue to teach and tune the system, with the aim of minimizing the possible range of error. In the next step, the product will move to the beta stage, after which it will be released to the market. Various medical organizations around the world are already interested in the device, including a huge international company, which has already successfully validated VoqX and plans to conduct a pilot on thousands of patients in Israel and Europe. "In anticipation of this stage, we are moving toward mass production of hundreds of units. They are expected to arrive in the coming months, after which we can move on to FDA and EU approvals," says Dr. Adler. "The objective is for the product to reach the market at the end of 2021. We already have letters of intent from entities such as Natali in Israel, and Riester, a global company in the field of stethoscopes. We have contacts with other organizations in the US, Europe, Japan, and China. We are setting up a production line designed to manufacture tens of thousands of units per year in the first stage."
Launching a home version
At the next stage, after the launch of VoqX, the company plans to launch a home version of the product, called PyXy. "This product will bring many of the doctor's abilities into the home," Dr. Adler declares. "Today there is at most a thermometer and a blood pressure monitor at home. Suddenly a small device will arrive that is capable of doing dozens of home tests. There is currently no product today that has such a range of capabilities for home testing, all in a device much smaller than a smartphone. PyXy will be able to detect a heart attack and call an ambulance itself, or issue a message to the patient: “You don’t have a heart attack. You’re in the midst of a panic attack.” Physicians will be able to receive a text message from the device informing them that there is suspicion that their patient, who performed a self-examination at home, requires medical attention. We have put a lot of effort into developing the digital back-end support for PyXy. The product will be furnished with an application and the ability to communicate with the patient's database. Two-way communication will allow the device at home to receive indications or information about the patient's history and at the same time automatically update the patient's file with the test results performed at home. The use of the device will be simple enough for any patient to conduct the self-examination.”
"In Europe, there are already plans to attach PyXy to medical teams that conduct home visits, where they need to perform tests and make decisions. It will also play an important role In nursing homes. Last year, Sanolla applied to the Horizon 2020 program of the European Commission for fighting COVID-19, at the head of a consortium of seven Israeli and European companies and entities. The project, coordinated by Sanolla, was one of only 23 winners, out of 454 submissions by 4,616 companies that competed in the area of COVID-19, and won a 5 million Euro grant. Our submission achieved a perfect score of 15/15 granted by each of the four panelists reviewing the proposal. The grant enables us to launch the home product next year, after receiving regulatory approvals from the CE and the FDA. The expectation is that our devices will serve physicians and patients alike, in and outside the home. We envision that our sound diagnostic products will start operating in the emergency room, move on to intensive care, and reach the doctor's clinic, the nursing home, and eventually every home."
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