News Digest 06.12.2023-08.12.2023

Regulators

The Ministry of Industry and Trade announced the development of a development plan for the medical industry until 2030

A Medical Industry Development Plan until 2030 will be developed in Russia. This was announced by Deputy Head of the Ministry of Industry and Trade Vasily Shpak at a meeting with the Ministry of Defense, Ministry of Health, FMBA, VEB.RF, RAS, the Medical Equipment consortium and market participants.

Also, the Ministry of Industry and Trade expects that the share of domestic medical equipment by the end of 2023 is projected to be 29%. To increase such a share and establish a balance between market needs and the production of the necessary high-tech products, a strategic document is also needed. It will improve the mechanism of state and municipal procurement, ensure the creation of a centralized system for ordering medical products and equipment, and indicate the priority role of interaction between the expert community and manufacturers in relation to assessing the real demand of the sector, the press service of the ministry reported.

Source: https://pharmvestnik.ru/content/news/Minpromtorg-soobshil-o-razrabotke-plana-razvitiya-medpromyshlennosti-do-2030-goda.html

The introduction of excise tax on the pharmaceutical substance ethanol was asked to be postponed

Support of Russia" asks to postpone the introduction of an excise tax on the pharmaceutical substance ethanol. The organization proposes to tighten control over the work of the wholesale link, as well as create mechanisms in the SMDLP that signal the risk of these drugs leaking out of control. The Ministry of Finance has already developed a bill introducing an excise tax on alcohol. If adopted, the changes will come into force in April 2024.

Source: https://pharmvestnik.ru/content/news/Vvedenie-akciza-na-farmsubstanciu-etanola-poprosili-otlojit.html

Market news

Developer Celsus acquired Botkin.AI

The Medical Screening Systems company, which is the developer of the medical decision support service (MDSS) Celsus, acquired 100% of the Intellogic company, a provider of a solution for analyzing chest images based on Botkin.AI artificial intelligence technologies. Now Intellogik is headed by one of the co-owners of the Celsus operator, Artem Kapninsky. Previously, the company belonged to a conglomerate of investors, one of the key ones was T-Medica, close to the Tashir group of Samvel Karapetyan.

Source: https://vademec.ru/news/2023/12/08/razrabotchik-celsus-priobrel-botkin-ai/

Other

Artificial intelligence has made it possible to independently detect the cardiotoxicity of chemotherapy

Artificial intelligence-based software has made it possible to detect cardiomyopathy in women receiving anthracyclines for breast cancer at an early stage using ECG monitoring. Using this technique will allow patients to independently monitor their heart condition.

The study included 989 women without cardiovascular disease who received anthracycline chemotherapy for breast cancer without metastasis. In all participants, the left ventricular ejection fraction remained normal before the start of chemotherapy with anthracycline drugs.

Source: https://medcitynews.com/2023/11/breast-cancer-radiology-burnout-rsna/

Developers of AI systems in medicine intend to reduce the risk class for such software

The Association of Developers and Users of Artificial Intelligence Systems in Medicine “National Medical Knowledge Base” (NBMZ) plans to work with Roszdravnadzor in 2024 to eliminate the provision on assigning a 3rd risk class to software with artificial intelligence (AI) upon its registration as a medical product. This was discussed during the annual meeting of the NBMZ, the association’s general director Boris Zingerman told MV.

A risk class is assigned to all medical products depending on the real risk and the likelihood of its occurrence during use, he clarified. The same approach will be valid for solutions using artificial intelligence technology: so that AI is assessed in accordance with the risk of harm to health that it can actually cause, and not on the basis of inflated fears that usually accompany the introduction of everything new, the expert emphasized.

Source: https://medvestnik.ru/content/news/Razrabotchiki-sistem-II-v-medicine-namereny-dobivatsya-snijeniya-klassa-riska-dlya-takogo-PO.html?utm_source=TG_post&utm_medium=Group&utm_campaign=Razrabotchiki-sistem-II-v-medicine-namereny

New registered medical devices

We are publishing a list of new medical devices registered from 12/01/2023 to 12/08/2023

https://cont.asiamc.ru/uploads/blogs/2023-12-08/6573487f14d89.pdf