News Digest 29.03.2024 — 01.04.2024
Regulators
The list of simplified registration of medical devices exceeded 2 thousand items
For the first time in 2024, the Interdepartmental Commission expanded the list of medical devices for simplified registration according to Decree of the Government of the Russian Federation No. 552 of April 1, 2022. 121 items were added to the list, including hip, knee and ankle prostheses, orthoses, walkers, hearing aids and other products. In the current edition, the list includes 2,166 products.
The Ministry of Industry and Trade intends to supplement the requirements for technical means for marking
The Ministry of Industry and Trade plans to establish requirements for technical means for working in a system for monitoring the circulation of goods subject to mandatory marking with identification means. The corresponding draft resolution is at the stage of public discussion.
Technical means of obtaining information about a product will have to:
- contain an identification key;
- recognize marking code in Data Matrix format;
- identify the type of recognized marking code;
- ensure the transfer of information about the marking code and (or) the identification code of the labeled product to cash register equipment and (or) be part of the cash register equipment;
- have a document on the results of checking compatibility with the operator’s technical equipment; the results of the check will be recorded in the register.
If the innovation is adopted, market participants when selling marked goods at retail will have to use technical means to recognize the marking code (a two-dimensional barcode in Data Matrix format, in some cases EAN) and determine the type of code. In this case, the technical means must be interfaced with cash register equipment, and information based on the scanning results must be sent to the operator.
Market news
Moscow authorities will invest 6 billion rubles in updating obstetric and gynecological services
The Moscow Department of Competition Policy announced in March four tenders for major repairs and retrofitting of four facilities of the obstetrics and gynecology service of the capital's Department of Health - three women's health centers and the maternity hospital of City Clinical Hospital No. 15. Also, the buildings of the State Clinical Hospital named after. V.V. Veresaev and State Clinical Hospital named after. F.I. Inozemtseva. The total starting price for all tenders was 11.8 billion rubles and separately for women’s health and obstetrics facilities – 5.8 billion rubles.
Other
Moscow will pay companies 48 million rubles for analyzing medical images using AI
The Moscow Department of Health (DZM) has approved a list of legal entities that will be paid grants for participating in an experiment on the use of innovative technologies in the field of computer vision for the analysis of medical images. In total, the list includes 18 companies that carried out 51 studies. For this they will be given a total of 48 million rubles.
The largest grant (6.8 million rubles) was allocated by the Department of Healthcare of the Russian Federation to the company AIRA Labs for a machine study of computed tomography of the chest organs for the presence of 11 pathologies. In total, AIRA Labs will receive five grants totaling 14.5 million rubles. According to SPARK-Interfax, this company was registered in May 2020 in Moscow and is owned by Mikhail Belyaev. AIRA Labs LLC closed 2022 with a net profit of 82 million rubles.
Mammography, fluorography, radiography and tomography of the chest and brain conducted by Medical Screening Systems LLC will be paid for. The total amount of financing will be 10 million rubles. SPARK-Interfax states that the company was registered in 2018 in Kaluga. Now it is owned by Igor Chernin through the parent company MSS. In 2022, Medical Screening Systems earned 86 million rubles.
The Department of Health appointed the highest price for the analysis of magnetic resonance imaging of the brain - from 281 to 1,130 rubles per study. For the development of computer vision for analyzing this type of visualization, two companies - Imvision and Intel Diagnostics - will be paid 3.5 million and 4.6 million rubles, respectively. Both companies were registered in St. Petersburg: Imvision LLC - in 2021, Intel Diagnostics - in 2020.
The use of artificial intelligence (AI) technologies in medicine is being actively promoted throughout the country. Thus, in 2023, using funds from the federal project “Creation of a unified digital circuit based on the Unified State Health Information System,” all regions of Russia (except Moscow and new territories) purchased 106 products with AI for 450 million rubles - most of the equipment (70%) is intended for image analysis.
In March 2024, Roszdravnadzor also expanded the list of purposes for which departmental subsidies can be spent. Among the new areas was methodological assistance with the implementation of medical products based on AI technologies in the regions.
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