News Digest 19.02.2024 — 22.02.2024
Regulators
The Supreme Court upheld the purchase of compatible medical equipment indicating the trademark
The tender that caused the conflict was placed by the Office for Regulation of the Contract System in the Procurement Sphere of the Voronezh Region on December 9, 2022. The auction involved the supply of electrocardiographs for the needs of clinics in the region for a total amount of 10.94 million rubles, while the terms of the purchase stipulated compatibility with the Cardiotechnika-07 ECG interpretation and analysis complex installed in clinics.
The winner was an individual entrepreneur who supplied a compatible wearable ECG and blood pressure monitoring complex "Decorda-8" from the same manufacturer - the Inkart company. The second company, which competed for the contract, filed a complaint with the regional OFAS, citing the fact that, in the company’s opinion, the customer did not have the right to establish additional requirements indicating the trademark.
The OFAS recognized the complaint as unfounded, however, in its decision it referred to the norm on the purchase of spare parts and consumables, and also considered the controversial medical equipment (the Cardiotechnika-07 complex produced by Inkart LLC and the wearable recorder Decorda) to be from the same manufacturer, but produced by a legal entity NJSC "Inkart", products from different vendors.
Medicom appealed the decision to the Arbitration Court of the Voronezh Region, but in April 2023 the court sided with the regulator. The Nineteenth Arbitration Court of Appeal and the Arbitration Court of the Central District in July and October 2023 upheld the first instance decision. In February 2024, the Supreme Court put an end to the case, deeming the purchase of equipment legal.
According to the courts, the clinic had the right to establish a restriction, since only such equipment could be used in the conditions of the customer’s current technical equipment at the time of purchase in compliance with the requirements of legislation in the field of healthcare, which cannot be considered as a limitation of the circle of potential procurement participants. Otherwise, the life and health of patients would be at risk. No restrictions on competition were found in the actions of the medical institution.
As of February 2024, it is allowed to purchase medical products with the indication of a trademark if they are purchased for the needs of a specific patient. The basis for this is individual intolerance or vital indications; the decision must be confirmed by a medical commission.
In January 2024, the Government of the Russian Federation approved a profile list of medical products for the purchase of which a trademark may be indicated. The list includes two products - a glucose reagent for in vitro diagnostics (its manufacturer is not disclosed), included at the request of the Ministry of Health of the Moscow Region, as well as a one-component closed colostomy bag for intestinal stoma.
Medicom is a Russian manufacturer of medical devices for heart rate recording. The company's portfolio includes multi-channel recorders Holter IN-33, Holter IN-33M and Holter IN-33T, as well as ABPM and combined monitors. According to SPARK-Interfax, in 2022 the company's revenue amounted to 135.3 million rubles, net profit - 54.9 million rubles.
FMBA will receive 440 million rubles from the federal budget for the development of bone marrow donation
The Russian government will allocate funds to the FMBA in 2024. The funding is intended to organize the work of laboratories subordinate to the agency. They collect blood from donors and type bone marrow samples.
At the moment, laboratories have already accumulated 40 thousand samples awaiting typing. Once the procedure is completed, they will be sent to the Federal Bone Marrow Donor Registry.
In connection with information about cases of deaths in the United States after the use of Philips ventilators, Roszdravnadzor reports the following
Recently, the world media reported that 561 deaths of patients were registered in the United States due to unsafe ventilators manufactured by Philips using PE-PUR foam.
The Federal Service for Surveillance in Healthcare constantly monitors the safety of medical devices in circulation on the territory of the Russian Federation. Back in 2021, when the first reports began to appear in different countries about the occurrence of fatal adverse events in different countries when using BiPAP and CPAP ventilators manufactured by Philips, Roszdravnadzor immediately informed participants in the healthcare system about a recall campaign regarding the mentioned devices Ventilation
Information about the measures necessary to prevent harm to the life and health of citizens was published on the official website of the Service dated December 3, 2021 No. 01i-1568/21.
Thus, thanks to timely measures taken by Roszdravnadzor, not a single patient receiving medical care in the Russian Federation was harmed by the use of BiPAP and CPAP ventilators manufactured by Philips.
Source: https://t.me/roszdravnadzor_official/2295
The government has expanded the list of medical devices implanted at the expense of compulsory medical insurance funds
The government has added one more medical device to the list of devices implanted into the patient’s body at the expense of compulsory medical insurance funds. The order was published on the Cabinet website.
One medical product has been added to the list - a rod for an internal spinal fixation system using bone screws (code 374900). The product is used in orthopedics: it is intended to provide immobilization and stabilization of spinal segments in the treatment of various instabilities or deformities of the spine, as well as as an adjuvant for spinal fusion (for example, in degenerative diseases of the intervertebral discs).
Patients and insurance organizations regularly have disputes over which medical products can be purchased using compulsory medical insurance funds and which cannot. At the end of 2023, the Supreme Court allowed the issuance of sensors for insulin pumps only by decision of a medical commission. The fact that the use of the system has a positive effect on a citizen’s health “is not of a legal nature,” the Supreme Court ruled.
Market news
United Imaging Healthcare entered the Russian market with a line of “heavy” medical equipment
As follows from the data of Roszdravnadzor, computer tomographs uCT 520, uCT 528, uCT 530, uCT 550, uCT 760 and uCT 780 from 40 to 160 slices have been approved for circulation. According to the manufacturer, the tomographs have an innovative Z-detector that allows for low-dose and higher-quality studies, 2D and 3D imaging capabilities, an Easy-Logic intelligent platform for fast and automatic scanning, a 30° tilting patient table and a more economical energy consumption.
According to Vademecum, two more lines of “heavy” medical equipment are being registered – a magnetic resonance imaging scanner of the uMR series and a PET/CT scanner of the uMI line.
The Russian CT market is estimated at 20–30 billion rubles per year. The Russian market of “heavy” medical equipment, despite the presence of the local manufacturer NIPK Electron, has traditionally been dominated by the big four manufacturers - Siemens Healthineers, GE Healthcare, Philips and Canon Medical Systems. The last three companies hatched plans for the localization of medical equipment, some of them were implemented, as in the case of the assembly of the Optima CT scanner, at the facilities of MTL LLC in Malakhovka, Moscow region; localization of CMS equipment was also being prepared at the facilities of the joint venture R-Pharm and CMS Arpi Canon Medical Systems. The Dutch vendor Philips expected to begin assembling MRI and CT scanners at the facilities of JSC Rentgenprom in Aprelevka, Moscow region.
Since the beginning of the 2020s, brands from Southeast Asia have begun to increase their presence in the market: in 2021 and 2022, the Chinese Anke introduced new multi-slice computed tomographs and a 1.5 Tesla magnetic resonance imaging scanner to the market. In 2022 and 2023, the Russian representative office of the Belarusian medical equipment manufacturer Adani registered in Russia a 32- and 128-slice Ventum computed tomograph, created on the basis of a localized version of the Chinese Insitum series tomographs from Sinovision Technologies. In addition to them, the Dominus computed tomography system from South Korean SG HealthCare is also preparing to be launched on the Russian market.
United Imaging Healthcare is one of the leaders in the production of “heavy” medical equipment and diagnostic equipment for medical imaging, including nuclear medicine in Southeast Asia, which has achieved recognition in the global market. The company's production bases are located in Wuhan and Changzhou, and its headquarters are in Shanghai. Regional headquarters are located in Poland, Malaysia, USA, Japan, Australia, Morocco, South Korea, Japan and South Africa. UIH medical equipment is supplied to 60 countries.
According to the company's financial statements, for the first half of 2023, UIH's revenue amounted to 5.27 billion yuan ($730 million, +26% year-on-year), net profit attributable to shareholders was 0.94 billion yuan ($103 million, +21 % year on year).
The first batch of domestic electronic stethoscopes went on sale
Great news from Skolkovo resident Medhard and chat admin @medtechchat Maxim Gumenyuk. Sales of a stethoscope for telemedicine consultations, assembled in the Russian Federation, have started in Russia - Phonendo! This is the first electronic stethoscope in Russia to receive a registration certificate from Roszdravnadzor.
Its innovation lies in the ability not only to listen to the patient’s heart and lungs, but also to simultaneously see sound in the form of audio and spectrograms. And all this in real time. For example, a patient with cardiovascular pathology living in Tyumen wants to consult a cardiologist in Moscow. The doctor sees the patient, hears the sounds of his heart and at the same time can monitor the heart rhythm spectrogram. The classic mode of face-to-face auscultation and self-recording of sound by the patient are also available.
Source: https://t.me/medicalksu/4848
The FDA warned medical device manufacturers about the increasing falsification of data by laboratories
The American regulator has identified an increase in the number of applications for registration of medical equipment with unreliable data obtained by third-party testing laboratories, including from China and India. Such laboratories fabricate information and also duplicate information from document packages of medical devices from other manufacturers. All this leads to limited access for patients and healthcare providers to new devices, and also causes disruptions in device supply chains, the department warns.
Therefore, FDA encourages manufacturers to take proactive steps to qualify third-party testing laboratories and carefully review all outsourced testing data.
Source: https://t.me/vademecum_live/13205
Other
Elon Musk said that the first person with an implanted brain chip was able to control a computer mouse “with the power of thought”
According to the head of the American neurotechnology company Neuralink, the patient feels well, and scientists have not yet identified any side effects after the operation. Musk also clarified that now experts are trying to get the test subject to imitate the greatest number of mouse button presses using signals from the brain.
Neuralink implanted the first chip into a human brain on January 28, 2024. The operation was carried out by a specialized robot, which surgically placed the implant in the brain area.
Despite the excitement around the solutions proposed by Neuralink, experts are concerned about the lack of complete information about the company’s neuroimplant. Also, third-party scientists note that the development is not revolutionary, and the only evidence of the successful completion of the operation is Musk’s statements.
Source: https://t.me/vademecum_live/13180
The first classes began at the simulation center of the Volga Research Medical University of the Russian Ministry of Health
Today, highly qualified specialists in the field of dentistry and maxillofacial surgery are already being trained at its base. New training programs for doctors will be developed in the near future.
The goal of the simulation center is for students to master practical skills using modern phantoms and simulators, microscopes.
Dental units are equipped with video visualization systems. This allows teachers to control the accuracy of students’ actions and guide them, and students to carry out manipulations at multiple magnifications. The digital technology laboratory is equipped with 3D printers, 3D scanners and computers with special software.
“Our university uses a three-level educational concept: training students in simulated conditions or on phantoms, mastering practical skills on biological models, and then master classes from leading specialists of the Institute of Dentistry and their direct participation in receiving patients,” noted the director of the Privolzhsky Institute of Dentistry Research Medical University of the Ministry of Health of Russia Evgeniy Durnovo.
Another task of the center is to carry out the practical part of state accreditation (both primary and primary specialized). All classes have high-tech audio and video recording systems that allow you to monitor the certification of graduates' practical skills.
A center for developing the skills of students of the Faculty of Dentistry was created as part of the Priority 2030 program. Doctors from any region of Russia can undergo training at the new simulation center as part of the Academic Mobility program of the Volga Research Medical University of the Russian Ministry of Health.
Rostec has created a prosthetic hand for small children in the form of a toy
The Moscow Production Association (MPO) "Metallist" of the Rostec state corporation has developed a prosthetic arm for children aged 3 to 7 years with a congenital malformation of a limb or its amputation.
The device is used for active grasping, holding objects and performing various movements involving fine motor skills. The product is activated by bending the arm at the elbow. The use of an active attachment by a child allows him to keep his muscles in good shape and ensures easy adaptation in the future to any other type of prosthesis, including bionic.
A distinctive feature of the new prosthesis is its compactness. The length of the product is 10.2 cm, width - 3.5 cm. Modern metalworking technology has ensured the design is light and durable, and stainless steel allows the product to be used in water.
In the future, MPO Metalist plans to diversify the appearance of attachments and produce prosthetics for children in the form of popular characters.
Source: https://rostec.ru/news/rostekh-sozdal-unikalnyy-detskiy-protez-ruki-s-avtorskim-dizaynom/
Sber wants to develop artificial intelligence (AI) for humanoid robots
Sber has started working on artificial intelligence for humanoid robots. It will be based on a large multimodal neural network. It will govern the basic models of navigation, manipulation and movement planning. This is stated in one of the vacancies on hh.ru, which RBC reviewed.
AI will learn new things on its own or from a minimum number of demonstrations. Robot training is part of a project to create your own anthropomorphic robot from Sber.
In 2024-2026, the conglomerate plans to switch to a “human-centric business model” and develop “new generation” artificial intelligence
Source: https://rb.ru/news/sber-ai-robot/
New registered medical devices
We publish a list of new medical devices registered from 02/16/2024 to 02/22/2024
Link to the list: [see. table in attachment]
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