News Digest 13.12.2024 — 20.12.2024
Regulators
Several orders of the Ministry of Health will lose their force due to new rules for registration of medical devices
The Ministry of Health proposed to recognize as invalid Order No. 300n of 16.05.2013 "On approval of requirements for medical organizations conducting clinical trials of medical devices, and the procedure for establishing compliance of medical organizations with these requirements." The document is undergoing public discussion until January 2, 2025.
The Ministry of Health also proposed to recognize as invalid its own Order No. 58n of 08.02.2013 "On approval of the Regulation on the Ethics Council in the Sphere of Circulation of Medical Devices." The draft of this document is also undergoing public discussion until January 2 of next year.
As follows from the explanatory notes to both documents, they were developed in connection with the adoption by the government of Resolution No. 1684 of November 30, 2024 "On approval of the Rules for state registration of medical devices." If approved, the orders will come into force on March 1, 2025.
The new Rules for State Registration of Medical Devices will come into force on March 1 next year. According to them, manufacturers of low-risk medical devices will be able to make changes to the dossier without an examination if they voluntarily undergo an assessment of quality management systems in production. As Dmitry Pavlyukov, Deputy Head of Roszdravnadzor, previously reported, the new rules do not require an examination as part of the state registration service - all assessments are carried out before applying to a government agency.
A bill on monitoring cartel agreements has been submitted to the State Duma
The government has submitted to the State Duma bill No. 801033-8 on amendments to the Federal Law "On Protection of Competition". As follows from the explanatory note, the document was created to establish the legal basis for the creation and operation of a state information system for the prevention, detection and suppression of cartel agreements.
The bill proposes to create a system for identifying cartels, the operator of which will be the federal antimonopoly authority. This system will contain information on the risks of concluding and implementing cartels based on the processing of information on tenders.
The authors of the document believe that daily automatic scanning of information about all tenders conducted using artificial intelligence and a risk-oriented approach will help to significantly save budget funds in billions of rubles "due to the decartelization of state and municipal purchases and the creation of competitive conditions for tender participants." If the law is adopted, it will also be necessary to adopt a government resolution "On approval of the Regulation on the state information system for the prevention, detection and suppression of agreements restricting competition." The Federal Antimonopoly Service (FAS) of Russia will be the executor of the document. The preparation period is six months from the date of adoption of the bill.
Earlier, the government commission on legislative activity approved the bill on the digitalization of the antimonopoly service. The document envisages the creation of the GIS "Anti-cartel". The launch of the system and its integration with the databases of departments and legal entities is scheduled for 2025.
Market news
Eiliton expanded production of vacuum tubes in the Dubna SEZ for 60 million rubles
The Ministry of Investment, Industry and Science of the Moscow Region reported that Eiliton (part of the Cerebrum-Unimed Group of Companies) launched the fourth automated line for the production of vacuum tubes for collecting venous blood at its site in the Dubna SEZ. The amount of investment in the expansion of the facility exceeded 60 million rubles.
According to the head of the ministry, Ekaterina Zinovieva, the capacity of the new production line is about 5 million tubes per month, and the total capacity of the enterprise has grown to 12 million tubes per month. "Thus, the company's output volumes have increased by almost 70%," Zinovieva said.
The company's serial production director Marina Kharchenko noted that in the near future the plant plans to organize its own production of polymer components using injection molding technology. This will create a full-cycle production.
The Eiliton company, part of the Cerebrum-Unimed Group of Companies, became a resident of the Dubna SEZ in 2013, opening a production complex and becoming the anchor project of the Medical and Technical Cluster of the Moscow Region. According to SPARK-Interfax, Eiliton LLC was registered in 2003 in Dubna. The owner of the company is Oleg Shalin. In 2023, the revenue of the LLC amounted to 500 million rubles, net profit - 103.2 million rubles.
The Primorsky distributor of Cerebrum concluded a deal with Unimed in the spring of 2022. The combined group of companies concentrated on the supply, development and production of equipment and consumables for clinical laboratory diagnostics. In the summer of 2022, Cerebrum closed a deal to acquire the main production asset of Unimed - the Eiliton plant, which produces tubes for collecting venous blood and hematology analyzers. The amount of the deal was not disclosed.
Earlier, in June 2020, Eiliton announced its intention to increase the production capacity of vacuum tubes and open the first automatic line in Russia for the production of double-sided needles for collecting blood. It was assumed that after modernization, the line's capacity will be 170 million tubes per year, which, according to the company's estimates, will allow it to become the largest manufacturer of specialized products. To implement the project, the company used a preferential loan from the Industrial Development Fund in the amount of 50 million rubles.
In October 2022, Eiliton began producing the Gemadiff 3 automatic hematology analyzers. The company's total investment in the development and production of medical devices exceeded 700 million rubles.
A research and production technopark was opened at Samara State Medical University to develop high-tech medical devices
A research and production technopark was opened at the Advanced Medical Engineering School (AMES) of Samara State Medical University (SamSMU). It plans to develop high-tech medical devices, hardware and software systems, and other innovative and import-substituting products.
The total area of the technopark is 300 sq. m. The division houses more than 20 units of specialized equipment. The institution will also conduct exploratory research, carry out rapid modeling, express prototyping, prepare samples for preclinical and toxicological studies, produce experimental and pilot batches, including for external customers. In addition, the technopark provides opportunities for high-precision 3D scanning, modeling and printing, silicone casting and turning and milling.
"Today, we have significantly increased the number of new projects. Many of them are generated by departments, PMISh, youth movements, and a startup center. It was decided to create a new structural unit for these projects. It will significantly speed up the process of entering the market, improve interaction with industrial partners, be more free and maneuverable in conducting commercial activities and developing competitive production in the field of medicine and health care," said Samara State Medical University Rector Alexander Kolsanov.
The Samara State Medical University Research and Production Technopark was launched as part of a federal project to create advanced engineering schools. In February 2024, the Council for Grants for the Creation and Development of Advanced Engineering Schools allocated 634.5 million rubles to SSMU for the training of engineering personnel and the creation and commercialization of new technologies. The same amounts were allocated to universities of the first group according to the degree of increasing the ambitiousness of goals and the effectiveness of the project.
In 2023, SSMU also took part in the federal project. Based on its own engineering school, the university opened a master's degree program in "informatics and computer engineering". According to university representatives, their scientists have completed research work under 84 contracts, including the development of new software products for the formation of technological processes for the manufacture of personalized implants and the search for solutions for psychological diagnostics and medical rehabilitation. In addition, in 2023, SSMU continued to develop its own digital telemedicine platform AUTOPLAN.
The federal project "Advanced Engineering Schools" was created in 2022. It is one of 42 initiatives of the Government of the Russian Federation in the state program "Scientific and Technological Development of the Russian Federation". The project was supposed to last until 2026, and the total funding for 4 years would be 60 billion rubles. During a meeting with students and workers of industrial enterprises in the Chelyabinsk region on February 16, 2024, Russian President Vladimir Putin supported the proposal to extend the project until 2030.
Other
Russian company Smart Engines patents AI in the US that reduces radiation exposure to patients during CT scans
Russian company Smart Engines, which specializes in developments in the field of artificial intelligence (AI), announced that it has received a patent in the US for a technology that reduces radiation exposure to patients during computed tomography (CT). The document was issued by the US Patent and Trademark Office on December 17. Smart Engines employees began working on the project in 2018, and an application for a patent in Russia was filed in 2021, but it is still under consideration. According to the developers, the AI allows to reduce the radiation load by 15% on average.
As the company told Vademecum, the neural network monitors the quality of the analyzed image, which is reconstructed from incomplete data, directly during the collection of projections. After receiving each partial reconstruction, the AI analyzes the quality of the 3D image, and if there is enough information to make a diagnosis, the procedure is completed early. Currently, in most cases, a single protocol is used during shooting - the number of images does not depend on the individual characteristics of a person, which can lead to excessive radiation exposure.
The development, as emphasized by Smart Engines, was tested for the diagnosis of pneumonia on the materials of the open COVID-CTset database, which contains clinical data of 377 patients, both healthy and diagnosed with viral pneumonia. The result of the study showed that the patented method, like the procedure carried out according to the standard protocol, allows to achieve high diagnostic accuracy, but using fewer X-ray images. Thus, on average, the proposed approach reduces the radiation load by 15%, but is especially effective in detecting pathology. With early diagnosis, radiation can be reduced by 25%. At the same time, when examining a healthy person, the procedure minimizes the need for a repeat examination, although it does not significantly reduce the radiation dose.
The thematic article was published in the British scientific journal Expert Systems with Applications. Scientists emphasized that AI can be used to improve the accuracy and efficiency of diagnosing cancer, aortic aneurysm, coronary artery pathology and other diseases. Registration of the development in the USA is necessary, as the company explains, so that it is not copied abroad.
According to SPARK-Interfax, Smart Engines Service LLC was registered in January 2016 in Moscow. The founder and majority owner of the company is Vladimir Arlazarov. Smart Engines revenue in 2023 reached 435 million rubles, net profit - 268.4 million rubles.
According to information from the company's website, its developers, among other things, together with representatives of the Russian Academy of Sciences institutes, were engaged in the creation of a software package for reconstructing X-ray tomographic images in real time to replace foreign products in the development of Russian industrial and medical tomographs. Arlazarov explained to Vademecum that everything the company did in the field of CT can be used in medicine. Over the past five years, Smart Engines has invested 200 million rubles of its own funds in this area, without attracting government funds. The first ideas for creating an AI patented in the USA appeared among employees in 2018-2019.
Vladimir Arlazarov also emphasized that developments with identical goals to the Smart Engines solution are being carried out all over the world. "The dose of radiation exposure to the patient can be reduced by making the organizational measures accompanying the CT examination more effective, improving individual means of radiation protection, modifying the design of the CT machine or changing the examination protocol. However, the use of artificial intelligence to reconstruct a 3D image from incomplete data is our innovative development," said the founder of Smart Engines.
"Before a new medical technology is used in real medical practice, it must be tested more than a dozen times, and this takes a lot of time. We are open to cooperation with domestic scientific organizations in the field of medicine, as well as with government agencies, so that our method of computed tomography proves its effectiveness not only in laboratory studies, but also in practice," concluded Arlazarov.
At the end of August 2024, the Spina Bifida Charitable Foundation informed Vademecum about the completion of the development by Yandex and the Academician V.I. Sechenov National Medical Research Center of Obstetrics, Gynecology and Perinatology. Kulakov of another AI – a computer vision service that can help doctors identify symptoms of spina bifida in the fetus using ultrasound of a pregnant woman.
Source: https://vademec.ru/news/2024/12/18/rossiyskie-razrabotchiki-zapatentovali-v-ssha-ii-dlya-kt/
Newly registered medical devices
We publish a list of new medical devices registered from 12/13/2024 to 12/20/2024
Link to the list: [see table in the attachment]
News
