April 12, 2022
The stethoscope picks up low-frequency sound waves that are generated in the body, which may indicate heart-lung disease. The device translates them into sounds that the human ear is capable of hearing
Startup company Sanolla Manshar has announced that the FDA has given 510 (k) approval for clinical use of the smart stethoscope it has developed, which is capable of detecting sub-sounds, which are sound waves at a frequency that the human ear is unable to hear. FDA approval is given after the company has also received an approval from the Ministry of Health in Israel. These approvals enable the start of sales of the device for clinical use in the United States and Israel. Under the current label, the stethoscope is intended to serve as a decision support tool in the diagnosis of heart-lung disease, but the company states that its goal is to replace all outdated technology-based stethoscopes with the new smart stethoscopes.
The human body also produces sounds in the subconscious spectrum, between 3 and 40 Hz, which are formed as a result of physiological processes such as blood flow in the blood vessels and heart or healthy air movement. These tiny mechanical oscillations produce sound waves in the subconscious realm that easily penetrate the tissues in the body, and therefore can be picked up by an external sensor. According to various studies published in the scientific literature, these sounds carry a great deal of clinical information about the function of the heart, lungs, and blood vessels, and abnormal findings in the subcutaneous frequencies may indicate various syndromes. For example, in narrowing arteries, pressure is created which, upon release, produces vortices, which can be “heard” at the subconscious frequencies.
However, these voices have not been accessible until now to the doctor’s ear at the clinic. The Snola stethoscope includes an accelerometer and a microphone, which together are capable of picking up the full range of sound, from the sub-audio to the audible frequency. In addition, through signal processing and dedicated frequency shifting algorithms, the device translates in real time the sounds received at the sub-audio frequencies into frequencies that the human ear can hear.
Snola’s stethoscope, VoqX, helps classify heart-lung diseases including chronic obstructive pulmonary disease (COPD), pneumonia, asthma and heart disease. According to the company, the product also opens the door to diagnosing heart-lung diseases that could not, until today, be diagnosed by listening. The company filed 20 patent applications, 8 of which have already been approved.
Snola was founded in 2016 by Dr. Doron Adler (CEO) and David Linhard (COO). To date, the company has raised $ 16 million: from founders, private investors, the NextLeap Ventures fund, the EU’s Horizon 2020 program and the Innovation Authority. The company plans to enter the A round of recruitment in the coming months in order to accelerate its marketing, sales, regulatory, and further development efforts.
Posted in categories: Start-ups, News, Medical Equipment
Posted in tags: FDA, Heart-Lung, Stethoscope, Snola, Undersea
