News Digest 11.10.2024 — 18.10.2024
Regulators
FAS and the Ministry of Health explained the specifics of purchasing medical devices in case of non-compliance with the NCMI code
The nomenclature classification of medical devices (NCMI) by type does not serve as their characteristic. It is unlawful to reject bids from a procurement participant in case of non-compliance with the NCMI code established by the customer, according to a joint letter from the Ministry of Health and the FAS of Russia (available on "MV").
The nomenclature classification of medical devices by type is a six-digit code assigned to a product from a specific manufacturer. On the market, similar products from different manufacturers may have different codes. At the same time, the standards for the provision of medical care indicate lists of equipment that must be purchased to equip medical organizations with specific NCMI.
According to the FAS, regional health authorities often believe that only the manufacturer of a product with a nomenclature classification included in the list can participate in the purchase. This approach limits competition in the market. The letter emphasizes that the NKMI is not a characteristic of a medical device, which means that when purchasing a product, there is no need to focus on the fact that its nomenclature classification matches that specified in the relevant acts.
Market news
The plastic medical device market is predicted to grow
The global medical polymer market will grow by 8% per year in the next five years and will increase by 1.5 times to $60.5 billion by 2029, according to analysts at MarketsandMarkets. The drivers should be the countries of the Asia-Pacific region, primarily China and India, Kommersant writes. The market growth is driven by the compatibility of medical plastics with sterilization, chemical resistance and lightweight design, which makes such plastics indispensable for the development of medical devices and implants. The transition to disposable medical products has further increased demand.
The Russian market for polymer medical products is still largely dependent on imports. At the end of 2022, the Sibur holding estimated the volume of this market at 125 thousand tons, 79% of products were imported from China and Europe.
According to HSE estimates, less than a third of the polymer grades required for the medical industry are produced in Russia. In particular, to meet the demand for disposable syringes by 2028, their production needs to be increased almost threefold, which will require import substitution to 7.5 thousand tons of polymers per year.
Sibur estimates the annual consumption of disposable medical syringes in Russia at 2.5-3 billion pieces per year, which corresponds to 14 thousand tons of raw materials. According to the company, the country's existing capacities are capable of fully satisfying the needs of the state and municipal procurement market, but they are currently underutilized. Thus, the largest syringe manufacturing plants operate at a maximum of 30% of capacity, since the trend of purchasing imported products due to their low price persists. Until recently, Russia did not have a local special grade of polypropylene for syringes that met modern quality and safety requirements. But today, the company notes, there are results of import substitution for disposable medical supplies along the entire technological chain, from the production of specialized grades of polymer raw materials to finished products. Sibur estimates the potential for the production of new special grades of polypropylene, polyethylene, PVC, synthetic rubbers, latex and polystyrene in the pharmaceutical and medical industries at 30-40 thousand tons per year. Market participants say that state support and protectionist measures are needed to develop local production. Thus, in order to create new production facilities for vacuum blood collection tubes in a short time, which would meet the needs of domestic laboratories and medical institutions, the key factor was to limit the participation of imported products in government procurement.
Source: https://medvestnik.ru/content/news/Rynku-medizdelii-iz-plastmass-prochat-rost.html
Moscow budget expenditures on healthcare will be increased by 8% in 2025
Moscow budget expenditures on healthcare will increase by 8% in 2025 — taking into account compulsory medical insurance funds to 1.1 trillion rubles. The program for modernizing city clinics will continue in the next three years, said Moscow Mayor Sergei Sobyanin.
According to him, a new framework for outpatient and inpatient medical care should be formed in Moscow by the end of 2028. Next year, the reconstruction of outpatient clinics will be completed and new buildings of the Moscow City Oncology Hospital No. 62 and the multidisciplinary complex of the St. Vladimir Children's City Clinical Hospital will be completed. Construction of inpatient complexes of the N.V. Sklifosovsky Research Institute of Emergency Care and the V.P. Demikhov City Clinical Hospital will begin. In total, 31 healthcare facilities will be built in 2025-2027.
Expenses on the provision of high-tech medical care at the expense of the city budget will exceed 15 billion rubles in 2025, and taking into account compulsory medical insurance funds - about 36 billion rubles. This will ensure the provision of such care to about all profiles, the press service of the mayor's office clarified.
Budget allocations for the state program "Healthcare Development" are planned in 2025 in the amount of 1.5 trillion rubles - 15% more than in the current year. In total, the federal budget for healthcare in 2025 provides 1.86 trillion rubles.
The expenses of the Federal Compulsory Medical Insurance Fund will increase by 15.4% in 2025 compared to the current ones, MV reported. More than 80% of these funds will be sent in the form of subventions to the regions.
Other
The Technopolis Moscow SEZ will open a tomograph production facility for 200 million rubles
Zanton Medical Systems, a new resident of the Technopolis Moscow special economic zone (SEZ), will invest more than 200 million rubles in the production of domestic tomographs at the Alabushevo site. The enterprise will open in 2025.
Zanton Medical Systems specializes in the production of devices used in medicine, based on the use of X-ray, alpha, beta and gamma radiation. The tomographs produced at the company's enterprises are used to diagnose neoplasms. The existing capacities allow for the annual production of three high-tech devices for radionuclide diagnostics. The new production facility will create 190 jobs. At the initial stage, the localization level will be 87 points. During 2025, it is planned to expand the range of works on equipment setup and assembly. Thus, by 2026, the localization level will increase to 94 points, and by 2027 it will reach 117.
According to Rusprofile, Zanton Medical Systems LLC was registered in August 2023 in Moscow. The beneficiary is Zhan Zhenyu. The company's revenue in 2023 amounted to 4 thousand rubles, net profit - 3 thousand rubles.
In August 2024, it became known that another resident of the Technopolis Moscow SEZ, Akrus Biomed, invested 460 million rubles in the creation of a production facility for biological and dermal equivalent of skin ("living skin"). The facility was launched at the Pechatniki site, where they plan to annually produce about 70 thousand biomedical cell products based on the developments of the N.K. Koltsov Institute of Developmental Biology of the Russian Academy of Sciences. Investments in the project amounted to 460 million rubles.
A service for analyzing the workload of medical equipment has been developed in Moscow
The Diagnostics and Telemedicine Center of the Moscow Department of Healthcare (DZM) announced the completion of the development of an online service for analyzing the workload of diagnostic equipment. In addition, the platform will be able to evaluate the efficiency of equipment and personnel. According to the DZM division, employees of Moscow polyclinics and hospitals will be able to use the program. Yuri Vasiliev, Chief Specialist in Radiation and Instrumental Diagnostics of Moscow and Director of the Center for Diagnostics and Telemedicine of the Moscow Health Department, clarified that the program uses data from the Unified Radiological Information Service EMIAS, to which diagnostic equipment from 155 medical institutions of the Moscow Health Department is connected.
With the help of the service, as Vasiliev clarified, medical workers will be able to track the equipment load not only of their own institutions, but also of other clinics in Moscow. According to Vasiliev, this function can be useful for planning, redistributing the load on devices, patient flows and making management decisions.
The service processes information on 20 parameters, including the percentage of equipment load, the number of studies, shift work, data on the medical institution and equipment and other aspects. The information, as emphasized in the Center for Diagnostics and Telemedicine, is regularly updated.
The Unified Radiological Information Service (ERIS) project, on the basis of which the new program operates, was initiated by the Center for Diagnostics and Telemedicine of the Moscow Health Department in 2020. The medical equipment of the departments of radiation and radionuclide diagnostics, departments of X-ray endovascular diagnostic methods and treatment of the institutions of the Moscow Department of Health is connected to the system. The archive of radiation studies of patients is also stored in the ERIS.
The Moscow Center for Diagnostics and Telemedicine is also the organizer of an experiment on the use of computer vision technologies for the analysis of medical images. In March 2024, the Moscow Department of Health began publishing data on the provision of grants to private companies participating in it. Thus, in the first half of 2024, the regulator paid 19 companies for specialized research for 150 million rubles.
The Ministry of Health will launch a federal incident on medical products with AI
By the end of the year, the Ministry of Health will launch another federal incident related to the introduction of medical products with artificial intelligence (MI with AI) into practical healthcare. To date, 37 such products have already received registration , Deputy Minister of Health Vadim Vankov said at the plenary session of the conference "Information Technologies in Medicine", the correspondent of "MV" reports.
This year, each region must implement at least three medical devices with AI. According to Vankov, 13 subjects have not yet been able to complete this task. He advised them to take a closer look at the Moscow platform with artificial intelligence services, access to which was opened to the regions this year. So far, only a few territories have taken advantage of this opportunity.
The details of the new federal incident on AI are not yet known. When it will start and its parameters will be announced by the Minister of Health Mikhail Murashko, Vankov told "MV".
So far, three federal incidents have been implemented in the healthcare system. "Incident 38" is aimed at making electronic appointments with a doctor as accessible as possible, "Incident 7" is associated with the introduction of electronic medical records, "Incident 9" is aimed at reducing excess mortality.
Source: https://medvestnik.ru/content/news/Minzdrav-zapustit-federalnyi-incident-po-medizdeliyam-s-II.html
Startup Emteq Labs presented the world's first glasses that recognize emotions
According to Forbes, the wearable technology developer Emteq Labs presented its new glasses called Sense, which are capable of recognizing emotions.
Sense glasses use contactless sensors that record the activation of facial muscles. In addition, the device is equipped with a camera that can instantly record the process of food consumption. Data is collected in real time, and then the information is analyzed using patented artificial intelligence (AI) algorithms. Users have the ability to control their data and share it with medical professionals if necessary.
A study published in the journal Frontiers in Psychiatry found that Emteq’s technology can differentiate between people with and without depression using facial expression data. This could significantly improve the diagnosis and monitoring of mental illnesses like anxiety disorders and autism.
But mental health isn’t the only area where the company believes its product could be useful, CEO Steen Strand told Forbes. It could also be used to monitor eating habits to help people manage their weight, assist with physical therapy for those suffering from facial paralysis, and more.
The company is collaborating with neuroscience researchers, and as it gathers more data, it aims to potentially move it through the regulatory process to use Emteq as a medical device for certain conditions.
Source: https://t.me/medicalksu/5287
New registered medical devices
We publish a list of new medical devices registered from 10.11.2024 to 10.18.2024
Link to the list: [see table in the attachment]
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