European Business: The stethoscope has been around for two centuries. Why do you believe it needs an upgrade – and which features has StethoMe added to this famous medical device?
Wojciech Radomski: The stethoscopes we have known for 200 years are acoustic stethoscopes. StethoMe® on the other hand is an electronic stethoscope and offers an incomparably higher sound quality. In contrast to traditional stethoscopes, StethoMe® can be used to record auscultation sounds and send these recordings to physicians who can play them back on their interface, which additionally gives them access to a spectrogram and thus enables them to recognize pathologies easily. StethoMe also features artificial intelligence algorithms, which analyze the recording and can detect abnormal sounds in the respiratory System.
European Business: Many physicians’ associations across Europe are skeptical about any moves to further telemedicine. Some of them argue that devices like a remote stethoscope may even endanger their patients’ health. How do you address such fears?
Wojciech Radomski: We are aware that telemedicine is in its infancy in many countries. However, both our stethoscope and the artificial algorithms that come with it were granted a Category 2a Medical Certificate (CE2274) in the EU. This medical certification of our AI algorithms is the first of its kind in the world. It is important to note, though, that StethoMe® does not make any diagnosis. Our device and our algorithms are intended to support physicians in the diagnostic process and provide them with an instrument that simplifies it. Our algorithms identify abnormal sounds in the respiratory system, but like a thermometer, they do not make a claim as to the nature of any specific illness. It is up to the physician to evaluate whether a child may have pneumonia or another affliction. Our objective is to make it easier for parents to consult a physician by sending recorded sounds to a doctor of their choosing, who can play them back and receive a detailed analysis of them. Through this, we want to help physicians and parents eliminate unnecessary doctor’s visits and speed up those that are indeed necessary.
StethoMe® does not make a diagnosis: That will remain up to the physician. Wojciech Radomski
European Business: It is not just the medical community, but also some regulatory bodies that are skeptical about telemedicine in general. What regulatory obstacles has StethoMe® encountered?
Wojciech Radomski: So far we have not encountered any skepticism on the part of the regulatory institutions and bodies, quite the contrary. In reputable studies it has been demonstrated, one of which was published this year in an edition of the European Journal of Pediatrics, that the StethoMe® algorithms are more sensitive and accurate in the detection of abnormal lung sounds than an examination conducted using a traditional stethoscope. The results of these studies were evaluated positively by an independent clinician from a notified body, which is confirmed by the CE-Certificate we have been granted. The algorithms were also verified with regard to user safety by an independent notified body accredited by the EU, in line with the EU MDD Directive.
The StethoMe® algorithms are more sensitive and accurate in the detection of abnormal lung sounds than an examination conducted using a traditional stethoscope. Wojciech Radomski
European Business: StethoMe® enables patients to cut down on doctor’s visits. Are there other medical procedures or devices that could be modified to be used from the patient’s home without a physician attending – and will we see more of this trend in the future?
Wojciech Radomski: The telemedicine market has been developing continuously on many levels. Besides our wireless stethoscope, glucose meters, spirometers, ECG-Holter monitors, and all kinds of diagnostic tests, which can be used to check our health status at home, have been well-received by the healthcare market. These solutions are very useful, especially in the treatment and monitoring of chronic conditions. They give patients greater freedom and a feeling of safety and comfort, while they enable physicians to provide quicker and more effective diagnostics. They also allow for a more accurate and thorough observation of treatment progress and adverse reactions to medications. All of this leads to a reduction in the number of unnecessary medical appointments, while it significantly improves the comfort of treatment. The market will surely see many more solutions which make it possible to administer healthcare procedures without the patient having to leave the comfort of his own home.
Interview: Julian Miller | Pictures: StethoMe®