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Celsus has received a registration certificate of a medical device for the highest hazard class


The system for the analysis of medical radiographic images using artificial intelligence "Celsus "(OOO" Medical Screening Systems") was the first in the Russian Federation to receive a registration certificate for a medical device for radiology in mammography and fluorography (risk class 3 in accordance with the order of the Ministry of Health of the Russian Federation (No. 686n of July 7, 2020). The registration certificate confirms the quality, efficiency, and safety of the solution.

"Celsus" – is a Support Decision-Making System in radiology (SDMS). It is included in the register of national software. The system detects the existence of benign or malignant tumors in X-ray images, highlights their localization, and then interprets the results according to international standards.

According to the chief freelance specialist in radiology and instrumental diagnostics of the Health Department of Moscow and the Ministry of Health of the Russian Federation for CFD, a director of the Center for Diagnostics and Telemedicine, Sergey Morozov: "Celsus" has actually passed the phase of post-registration tests of medical artificial intelligence as part of the Moscow experiment on computer vision:

"Before connecting to the general information circuit of ERIS EMIAS, the service was validated on independent sets of examinations in order to check the diagnostic accuracy, sensitivity, and specificity of the algorithms in the "field" conditions. Then, during 2020, "Celsus" was used in real clinical practice by Moscow radiologists. This allowed the developers to receive expert feedback from doctors and find weaknesses for further training of the service."

Artem Kapninsky, Commercial Director of "LLC Medical Screening Systems":

"Our product has proven its compliance with the current requirements for quality, safety, and efficiency. Already today, doctors together with Celsus are saving people's lives. Of course, artificial intelligence cannot become a full replacement of a specialist, but it greatly simplifies the process of making a diagnosis, allowing you to gain time and diagnose oncology as early as possible, and start treatment faster."

Candidate of Medical Science, Oleg Bronov, Executive Director of the Russian Society of Radiologists and Radiologists (RSRR):

"This is great news! The system of medical decision-making "Celsus" is a high-quality product, and the capabilities of the system permit it to be used not only at the stage of screening examinations, but also to be used in the practice of polyclinics and hospitals, which was confirmed by a joint clinical research. The system allows not only to save the doctor's time for searching for pathological tumors but also to double-check, conduct an audit, which allows you to increase the accuracy of the diagnosis. Such systems already allow us to reach a new level of patient examination."

The use of "Celsus" in practical work during screening will minimize the risks related to the human factor, compensate for the lack of primary care staff, increase the diagnosis of cancer at early stages.

Deputy Minister of Health of the Kaluga Region Alexander Korolev:

"Celsus" became the first solution, thanks to which, doctors really felt the benefits of modern technologies in the field of artificial intelligence, both in reducing the time for diagnosis and in the form of an objective assistant that insures from making mistakes. The region is already ready to use the service."

The effectiveness of "Celsus" Clinical decision support system (CDSS) was confirmed during the pilot and commercial tests in a number of regions, as well as an experiment of the Moscow Health Department on the use of artificial intelligence services in radiology. As a result, Celsus became one of the leaders among the services participating in the experiment – both in terms of the number of processed examinations (more than 350 thousand) and in terms of the accuracy of the interpretation of the results.

"Clinical Research Center "Medsi" was among the first in Russia to successfully test medical software using artificial intelligence technologies, says Anton Silin, Deputy Medical Director of radiology and Instrumental Diagnostics of the Medsi Group of Companies. – Despite the hard conditions for conducting clinical tests, Celsus has demonstrated a high level of accuracy, which makes it a real assistant in the daily work of a radiologist. Digitalization is one of the priority directions of Medsi's development, and we are glad that new high-quality products are entering the market and increase the quality and speed of providing medical services."

"High-quality and accurate diagnosis at an early stage significantly increases the effectiveness of therapy and, as a result, the probability of a favorable prognosis for patients with cancer. That is why diagnostic solutions based on artificial intelligence are so in demand today. The Celsus system is one of the participants of the iLab startup accelerator, organized by "AstraZeneca" together with "Skolkovo". Within it we will be able to evaluate the optimal way of integrating the system into clinical practice, said Evgenia Logacheva, AstraZeneca's Medical Director for Oncology.

In 2020, the company attracted investments from the STI venture fund in the amount of 180 million rubles for the growth of sales and technological improvement of the platform. At the moment, the solution is passing the procedure of evaluating compliance with the requirements of the directives and harmonized standards of the European Union for entering the international market.

Kirill Tishin, Investment Director of the Venture Fund of the State Technology Initiative under the management of Kama Flow:

"Today, the use of artificial intelligence in medicine is one of the most attractive investment directions, and medical images are the direction where artificial intelligence is already actively used. Considering this direction for investment in 2020, we have thoroughly analyzed the projects and teams in Russia that worked in the field of radiology. Among the many companies, Celsus immediately pays your attention. The sensitivity of approaches, technological development, the quality of the final product, the understanding of market needs – not every company can brag about it. We are confident that the registration of Celsus as a medical device for the highest risk class is a real big break that will open up great prospects for the explosive growth of the Russian market for the use of artificial intelligence in medicine."