News Digest 28.03.2025 — 04.04.2025

Regulators

The Ministry of Health has approved a new composition of the Ethics Council

The Ministry of Health of the Russian Federation has changed the composition of the Ethics Council, which was approved in 2022. Among others, it includes Zhanna Galeeva, an expert analyst at the Department for the Implementation of Functions of the National Medical Research Center for Geriatrics of the Pirogov Russian National Research Medical University; Vladimir Gureev, chief researcher at the Laboratory of Drug Toxicology at the Institute of Experimental Cardiology named after Academician V.N. Smirnov, the National Medical Research Center for Cardiology named after Academician E.I. Chazov; Andrey Zaborovsky, head of the Department of Pharmacology at the Russian University of Medicine; and other specialists. In total, seven people are included in the new composition, nine are excluded.

Source: https://vademec.ru/news/2025/04/02/minzdrav-utverdil-novyy-sostav-soveta-po-etike/


Market news

MTL to launch second plant for X-ray equipment production by 2026

President of Medical Technologies Ltd. (MTL) group Anatoly Dabagov announced at a meeting with Russian Prime Minister Mikhail Mishustin that a plant for the production of components for the company's X-ray equipment is planned to be launched in Russia in 2026. X-ray generators, complex tripod devices, digital detectors and other devices will be manufactured there. According to Dabagov, the project is being implemented in the context of the strategy to achieve technological sovereignty.

Source: https://vademec.ru/news/2025/04/03/mtl-k-2026-godu-zapustit-vtoroy-zavod-po-vypusku-rentgenovskogo-oborudovaniya/

The April plant will produce 79 million medical products per year in Kuban

The enterprise LLC April, the project of which is being implemented in the Seversky district of Kuban, will produce 79.9 million medical products per year by 2030. This was reported to Vedomosti Yug by the Ministry of Industrial Policy of the Krasnodar Territory.

We are talking about the production of absorbent underwear, urine and ostomy bags, catheters, as well as self-catheterization kits. The volume of investment in the project is 1 billion rubles.

The investor has already built a medical products workshop with an area of 1,500 square meters, and a specialized clean zone for the production of sterile catheters is currently being installed and launched. A 3,000 sq. m. workshop for the production of absorbent underwear and a disposable diaper line has also been reconstructed.

An agreement on the implementation of this project was concluded between April LLC and the administration of the Krasnodar Territory at the St. Petersburg International Economic Forum in 2024. An agreement of intent was also signed there with the Krasnodar Ortho-Market LLC to create a production facility for prosthetic components. The investment volume will also amount to about 1 billion rubles, the design capacity is 9,750 products per year.

To date, the company has conducted a study of knee modules and prepared technical documentation.

“The design documentation for an advanced single-axis knee with rotary hydraulics is at the final stage, and the design documentation for hydraulic cylinders for microprocessor knee modules is at the initial stage,” the ministry’s response says.

As reported by Vedomosti Yug, in March, the Kuban Ministry of Industry and Trade announced the implementation of four more projects in the pharmaceutical and medical sectors with a total investment of 1.5 billion rubles.

Source: https://south.vedomosti.ru/south/news/2025/03/28/1100104-meditsinskih

Smolensk ex-deputy receives real term for fraud in the supply of medical devices to a hospital

On April 1, the Zadneprovsky District Court of Smolensk sentenced former City Council deputy Vladimir Burduli under Part 4 of Article 159 of the Criminal Code of the Russian Federation (fraud on an especially large scale). He was found guilty of three episodes of fraud in the supply of medical devices (MD) for the needs of Clinical Hospital No. 1 in Smolensk and sentenced to 3.2 years in a general regime penal colony.

According to the court's decision, he was also fined 500 thousand rubles. Previously, the defendant fully compensated for the damage caused by the crime - more than 16 million rubles.

The court and investigation established that Vladimir Burduli actually managed the financial and economic activities of several companies. By inflating the initial price of contracts for the supply of medical supplies for the needs of Clinical Hospital No. 1, he committed theft in the amount of over 16 million rubles.

The Investigative Committee of the Russian Federation for the Smolensk Region opened a criminal case under the article on fraud in March 2023. At that time, regional media noted that Vladimir Burduli is the owner of 100% of the shares in the company - the supplier of medical products "Pharmgroup". After the arrest, the ex-deputy was placed in custody. Also in the pre-trial detention center were the head of the commercial department of "Pharmgroup" Yuri Kutko and the former chief physician of Clinical Hospital No. 1 Sergei Kryukovsky. As explained by the press service of the FSB, Burduli was in overall charge, his subordinate Yuri Kutko ensured interaction between the organizations, and the head doctor Kryukovsky ensured the possibility of concluding contracts with the necessary companies. The Investigative Committee did not provide information on the stage of consideration of the cases against Kutko and Kryukovsky.

Source: https://vademec.ru/news/2025/04/02/smolenskiy-eks-deputat-poluchil-realnyy-srok-za-moshennichestvo-pri-postavke-mi-v-bolnitsu/


Other

AI has learned to analyze the cerebellum from MRI images

Scientists from the Polytechnic University of Valencia (UPV) and the French National Center for Scientific Research (CNRS) have developed the world's most accurate artificial intelligence (AI) program for analyzing the cerebellum based on MRI images.

Despite its small size, the cerebellum contains about 50% of all neurons in the brain and plays a key role in cognitive, emotional, and motor functions. However, its complex structure makes it difficult to analyze using traditional MRI methods.

DeepCeres solves this problem by using neural networks to transform standard images into ultra-high resolution. This allows researchers and doctors to obtain detailed images of the cerebellum without the need for expensive equipment.

The developers note that DeepCeres is able to accurately measure 27 different structures of the cerebellum. This opens up new possibilities for diagnosing and studying neurological and psychiatric diseases, and helps to study the role of the cerebellum in the development of neurodegenerative pathologies.

In five months of operation, the program processed data from almost 15,000 patients.

Source: https://www.ferra.ru/news/techlife/ii-nauchilsya-analizirovat-mozzhechok-po-snimkam-mrt-21-03-2025.htm

AI has learned to analyze the entire sleep cycle

Scientists from the Icahn School of Medicine have developed a tool based on artificial intelligence (AI) that can analyze the entire night's sleep. This method uses a transformer architecture similar to that used in models such as ChatGPT. The results of the study were published in the journal SLEEP.

The researchers conducted one of the largest studies, analyzing more than a million hours of sleep. The new method improves sleep analysis, reducing variability and providing a standardized approach for scientific and clinical research. The model was trained on a large data set, including polysomnography, a method that measures key physiological signals.

With the help of AI, specialists will be able to more effectively identify sleep disorders, such as apnea, and assess risks associated with sleep quality. In the future, this tool may become a powerful assistant in the diagnosis and treatment of various diseases associated with sleep disorders.

Source: https://www.ferra.ru/news/techlife/ii-nauchilsya-analizirovat-polnyi-cikl-sna-17-03-2025.htm


New registered medical devices

We publish a list of new medical devices registered from 03.28.2025 to 04.04.2025

Link to the list: [see table in the attachment]

News

News Digest 05.12.2025 — 12.12.2025
12.12.2025
Roszdravnadzor (the Federal Service for Surveillance in Healthcare) regulates the issuance of permits for clinical trials of medical devices in accordance with EAEU rules; The ability to confirm localization of production with the ST-1 certificate may be extended until June 30, 2026; The Ministry of Labor will establish technical specifications for hearing aids
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News Digest 28.11.2025 — 05.12.2025
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The launch of the scoring system for assessing drug localization will be postponed; The volume of major public medical procurement for the first nine months amounted to almost 1.1 trillion rubles; The UK was the first country to receive a full exemption from US tariffs on pharmaceuticals
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News Digest 21.11.2025 — 28.11.2025
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EAEU regulations will expand the permissible cases for the circulation of unregistered medical devices; The Government Expanded Risk Categories for Medical Device Inspections; The government has clarified the labeling parameters for disposable technical rehabilitation devices
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