News Digest 11.03.2024 — 13.03.2024
Regulators
Roszdravnadzor has reduced the period for issuing permits for the import of samples of medical devices for registration
Roszdravnadzor intends to update the administrative regulations for issuing permits for the import of medical devices into the territory of the Russian Federation for state registration. The draft order was published on the portal regulation.gov.ru.
The document must be received in lieu of Roszdravnadzor Order No. 11205 dated November 30, 2020. The main change is the reduction of the period for providing government services: from five working days to eight hours from the moment of registration of the application. To do this, enter preliminary profiling of applicants by filling out a form on the public services portal.
The status of service recipients is also changing. To be able to contact legal entities and owners instead of manufacturers and their authorized representatives.
Order No. 1663-st of December 26, 2023 approved GOST R 52770-2023 “Medical products. System for assessing biological effects. General safety requirements"
Document: https://files.stroyinf.ru/Data/819/81930.pdf
Market news
An oriental medicine center will be built in Buryatia for 140 million rubles
The Republican Agency for Public Procurement of Buryatia has announced a tender for the construction of a clinical treatment and rehabilitation center “Center for Oriental Medicine” in Ulan-Ude. The initial (maximum) contract price is 140 million rubles.
According to the UIS in the field of procurement, the contractor must begin work from the date of conclusion of the contract, and complete it no later than July 2025.
The total area of the center will be 6,048 square meters. m. It will consist of a medical and rehabilitation building, a hotel with 100 beds and a swimming pool. The complex will include a day hospital department, a diagnostic and advisory area (consultations with medical specialists, a laboratory, ultrasound and functional diagnostics), an oriental medicine department (reflexology, massage, manual therapy, etc.), a physical therapy department (gym, kinesiotherapy room, exercise therapy and yoga rooms) and a balneotherapy department (baths, showers).
The uniqueness of the center will lie in the combination of modern medical technology based on the practices of oriental medicine (Tibetan, Mongolian and Chinese), the traditional school of herbal medicine of Buryatia and manual healing techniques. The emphasis will be on self-healing processes.
A clinic will be built in Krasnodar for 1.3 billion rubles
The state government agency of the Krasnodar Territory “Directorate of Public Procurement” announced a tender for the construction of a clinic in the capital of the region. The initial price of the contract is 1.3 billion rubles.
According to the UIS in the field of procurement, the customer set the work completion period at 27 months. The estimated commissioning date for the facility is 2026.
The total area of the land plot for construction is 28,015 sq. m. m, the area of the clinic itself is 11,500 sq. m. m. It is planned that the institution will be able to accommodate 750 people per shift. The outpatient department will include a children's department for 200 visits with a day hospital for 12 beds, an adult department for 400 visits with a therapeutic day hospital for 10 beds, an antenatal clinic for 150 visits with a day hospital for 6 beds, an ambulance station and a trauma center.
In addition to the construction of the building itself, it is planned to improve the territory (landscaping, construction of a children's playground and a covered stroller, parking for official vehicles with 8 parking spaces, for visitors with 30 parking spaces and for employees with 137 parking spaces).
Source: https://vademec.ru/news/2024/03/11/v-krasnodare-postroyat-polikliniku-za-1-3-mlrd-rubley/
In the Moscow region, X-ray equipment will be purchased complete with renovation of premises for 2.5 billion rubles
The Committee on Competition Policy of the Moscow Region announced 10 tenders for work on the preparation of project documentation, major repairs of X-ray diagnostic, fluorography and mammography rooms in medical institutions in the region. The terms of purchase, in addition to construction work, include equipping each of the offices with specialized equipment. The total initial maximum contract price is set at 2.472 billion rubles; the results of the tenders will be announced in March 2024. A year ago, regional authorities resorted to a similar mechanism for purchasing construction services when equipped with computer and magnetic resonance imaging scanners.
In total, since the end of January 2024, the authorities of the Moscow region have announced 10 auctions, which involve the development of design documentation, carrying out surveys, carrying out major repairs and equipping with medical equipment. Deliveries are planned to city and regional hospitals, among the recipients are Dmitrovskaya, Noginskaya, Orekhovo-Zuevskaya, Protvinskaya, Ramenskaya, Shchelkovskaya, Dolgoprudnenskaya, Voskresenskaya hospitals, Podolsk regional clinical hospital, Odintsovo regional hospital, Reutov clinical hospital and other medical institutions.
According to the terms of the competition, the contractor must complete the work within 220 days from the date of conclusion of the contract. They pass under two OKDP2 codes - the performance of work and the provision of services related to the simultaneous performance of engineering surveys, the preparation of design and working documentation, the execution of work on major repairs of a capital construction project and the supply of equipment necessary to ensure the operation of such a facility.
In total, it is planned to purchase 9 sets of fluorographic equipment for 133.29 million rubles, 9 and 5 sets of mammography machines for 188.15 million rubles and 104 million rubles, respectively, 5 fluoroscopic systems for 144.8 million rubles, 12, 15 and 16 x-ray systems of different types, respectively, for a total amount of almost 1 billion rubles. The initial maximum contract price includes the cost of repair work, which accounts for 15–30% of the contract price.
The results of two competitions have already been summed up - 10 sets of fluoroscopic equipment for 287.8 million rubles will be supplied by the capital's Stroysitikomplekt LLC, and another 13 complexes with repairs went to Zapsibgazprom-Gazification LLC. Both suppliers are not core players in the medical devices market. Another competition for a total amount of 272.4 million rubles was left without applications from participants.
For the first time, the authorities of the Moscow region massively applied the innovative mechanism for the purchase of medical equipment, along with services for the preparation of premises, including design work, surveys and major repairs in already built and operating medical institutions, in 2022. Then the regional competition policy committee announced 16 tenders for the supply of X-ray machines, computer and magnetic resonance imaging scanners, fluorographs, angiographs and mammographs for a total amount of 2.935 billion rubles.
Purchases are carried out under the program for upgrading analog equipment to digital technology in the Moscow region. In 2024, the regional authorities plan to purchase 137 pieces of heavy medical equipment for a total amount of 4.6 billion rubles. The range of medical equipment includes X-ray machines, mammographs, fluorographs, computed tomography machines, MRI and angiographs.
New high-tech equipment has become operational at the Clinical Oncology Dispensary of the Omsk Region
The Federal Service for Surveillance in Healthcare constantly monitors the implementation of the National Healthcare Project. According to the Territorial Authority of Roszdravnadzor for the Omsk Region, new high-tech medical equipment was supplied and put into operation at the Clinical Oncology Dispensary of the Omsk Region within the framework of the implementation of the federal project “Fighting Oncological Diseases” - a remote gamma radiation therapy unit. The unit is intended for stereotactic radiosurgery and targeted radiotherapy for focal lesions and tumors for which radiation therapy is indicated.
The territorial body of Roszdravnadzor for the Omsk region will continue to monitor the pace of implementation of national projects in the region.
Source: https://t.me/roszdravnadzor_official/2340
Other
Cardiac surgeons from Sechenov University have developed the world's first aortic valve from homopericardium
Within the framework of the Innovative Scientific School under the leadership of the Director of the Clinic of Cardiovascular Surgery of the First Moscow State Medical University. I.M. Sechenov of the Ministry of Health of the Russian Federation Roman Komarov developed the world's first biological valve, the basis of which is a homologous (donor) pericardium.
This development is unique in everything: from the processing and shape of the sashes, to the frame and storage solution. Thanks to a special processing method and storage solution, the valve components do not calcify - this is one of the most common problems when implanting biological prostheses. All this, together with the most physiological valve design, suggests that the service life of this product will be 40% longer than that of aortic valve prostheses currently on the market. For patients, this means that the homopericardial valve will most likely be installed for life, without subsequent replacement.
AI has proven its ability to predict potential diseases from patients' electronic medical records
Artificial intelligence can assess the risks of potential diseases using patients’ electronic medical records (EMRs). This hypothesis was confirmed by a retrospective experiment conducted by specialists from the Artificial Intelligence Laboratory of Sberbank and the Ministry of Health of the Sakhalin Region. The AI algorithm processed more than 100 thousand EHRs and gave a forecast for the occurrence of malignant neoplasms (MNT) for 2022. As a result, when comparing predicted and actual values, the artificial intelligence system was able to detect a multiple additional set of patients with confirmed risks of MNT. Representatives of Sberbank reported this to CNews.
The tested technology has the potential to complement the existing mechanism for the selection and prevention of cancer in Russia, which is based on clinical examination protocols. Sber's technology can be used both to rank existing clinical examination lists and prioritize patients by risk level (for the earliest possible detection of cancer), and to expand existing dispensary programs (for the most complete detection of cancer).
The parties are now discussing the possibility of a prospective study to confirm the stated characteristics of the AI model and determine optimal scenarios for its use. Considering the complexity and cost of treating late-stage cancer, the developed AI technology has the potential to make a significant contribution to the early detection and control of cancer. It is precisely such technologically advanced Data Driven solutions that will determine the future of countries leading in terms of level and quality of life.
PSU is working on creating a system of comprehensive rehabilitation for people with mental disorders
Penza State University, subordinate to the Russian Ministry of Education and Science, is working on a large-scale project using virtual reality technologies. The solution will help people with special needs compensate for the negative consequences of disability. The work is being carried out within the framework of government assignments. The cooperation of scientists, young specialists, graduate students and university students has developed and registered more than ten objects of intellectual property. Work continues. TASS reported this.
Source: https://pnzgu.ru/news/2024/03/7/11190775
A “patch” has been developed in the United States that allows people without vocal folds to speak
The device consists of five thin layers. The outer shell is made of soft and flexible silicon material, and in the middle there are micromagnets that generate a magnetic field that changes with the movement of the throat muscles. The other two layers consist of spools of copper wire. They are the ones who convert these changes in the magnetic field into electrical signals, which are then fed into a machine learning algorithm, which in turn converts the impulses into speech.
The development weighs only 7 grams and is resistant to moisture. The results of testing the “patch” on people who do not have speech problems showed that the device is capable of working every day with clear voice output with an accuracy of 94.6%.
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