News Digest 11.07.2025 — 18.07.2025
Regulators
Roszdravnadzor has proposed recording errors in medical devices with AI
Roszdravnadzor has developed a draft Procedure for the transfer of information on processed data and the results of actions of medical software using artificial intelligence (AI). The information will be recorded in the automated information system (AIS) of the agency. If approved, the order will be valid until December 31, 2025. According to the draft, regions that use medical devices with AI technologies have the right to send monthly data on the operation of such technologies to the Roszdravnadzor AIS. Information on access to the platform will be posted on the official website of the agency.
After gaining access to the personal account of the system, subjects must connect medical devices to the software interface, which ensures automatic transfer of information. The information will include the name of the medical device, the number and date of the RU, the area of application, data on the period for which the information is provided, the number of processed studies, the results of the medical device, as well as data on the number of errors (network and those that occurred during the processing of studies). In addition, the AIS will reflect the TIN of the medical institution or its unique identifier OID. In March 2025, the Russian Ministry of Health approved the
Code of Ethics for the Use of AI in Healthcare. The main objective of the document is to define the rights and obligations of AI subjects, as well as mechanisms for regulating the application of the code. Vademecum talked to developers of thematic AI solutions, representatives of the medical community and medical universities, asking experts to assess the practical significance of the new regulation for the development of the healthcare industry. Thus, the CEO of Smart Engines, Doctor of Technical Sciences Vladimir Arlazarov believes that “the main problem with using AI technologies in healthcare is the difficulty of determining responsibility in the event of an error.”
Market news
Intex to invest 338.5 million rubles in expanding production of compression medical products
The Russian company Intex will invest at least 338.5 million rubles in launching a new production facility and expanding existing capacities for the production of high-tech compression medical products at the Dobrograd SEZ in the Vladimir region. It is expected that the new equipment will increase production volume by two to three times - up to 15 million units of goods per year. Among the company's new products are an innovative cohesive bandage, a bandage with a pressure indicator, and universal-size medical hosiery.
VTB Bank provided a bank guarantee for the purchase of equipment and the launch of new production for the specified amount, the credit institution said in a statement. The new capacities will increase the production of medical knitwear used for the treatment, prevention and rehabilitation of various complications associated with varicose veins, pregnancy and childbirth, during and after abdominal surgeries and injuries.
Key products include the innovative cohesive bandage "Intex fixing", a bandage with a pressure indicator "Intex PRO" and universal-size medical knitwear "Intex universal". "Intex" is a Russian manufacturer of compression stockings, bandages, elastic bandages and other products.
The agreement on the establishment of production in the SEZ "Dobrograd" was signed in June 2021 at the St. Petersburg International Economic Forum. It was assumed that the enterprise would be built on an area of 2.6 hectares. The volume of investments in the project was estimated at 241 million rubles, the launch of production was scheduled for the fourth quarter of 2022. Later, the volume of investments increased to 250 million rubles. According to SPARK-Interfax, Intex LLC was registered in December 2020 in Dobrograd, Vladimir Region and is 100% owned by Oleg Balashov, the owner of Intertextile Corp. LLC. In 2024, the parent company earned 738 million rubles, with net profit amounting to 303 million rubles.
Rostec has launched a new mobile artificial lung ventilation device "Mobivent ARM"
The state corporation has received a registration certificate for a new mobile artificial lung ventilation device "Mobivent ARM", which is intended for use in medical transport, hospitals, field hospitals and premises with increased requirements for electromagnetic compatibility, including MRI rooms. Serial production is planned to begin by the end of 2025.
The equipment was created by the Ural Instrument-Making Plant, which is part of the concern "Radioelectronic Technologies" (KRET) of Rostec. The line includes two variants: Mobivent ARM-T for transport, Mobivent ARM-M for hospitals.
The corporation emphasized that the devices were created in close cooperation with the medical community. This allowed for the ease of use requirements to be taken into account: the device's touch screen works even when wearing gloves. h. "Mobivent ARM" received the "Best Industrial Design of Russia - 2024" award. In October 2021, the plant received 630 million rubles from the federal budget for the development of a new line of Mobivent ventilators, which also includes the universal Mobivent device, Mobivent Oxy for high-flow oxygen therapy, Mobivent Neo for newborns and the expert class Mobivent Maxi device.
Production of components for endoprostheses to appear in St. Petersburg
The Komsomolskaya Pravda plastics processing plant in St. Petersburg intends to establish the production of components for endoprostheses from domestic ultra-high molecular weight polyethylene (UHMWPE).
The specialists have already developed the first test samples and intend to contact the Ministry of Industry and Trade of the Russian Federation for assistance in implementing the project. The enterprise may begin serial production by July 2026. Elena Orlova, General Director of the Komsomolskaya Pravda Plastics Processing Plant, noted that there is currently a need to produce UHMWPE rods for endoprostheses with a diameter of 45 to 65 mm. In addition to test samples, the enterprise has also developed technological regulations and a technological process, and conducted pilot tests to obtain samples.
According to Orlova, the plant intends to offer the first developments and samples for use at the Military Medical Academy, after which it will be possible to enter state and private clinics. The costs of producing UHMWPE products, working out all the stages of their certification and working out technologies for the production of various types of equipment are estimated at tens of millions of rubles. Among the problems in organizing the plant, they name the lack of an institute for certification of this type of product.
Source: https://spb.vedomosti.ru/business/articles/2025/07/15/1124605-naladyat-proizvodstvo-endoprotezov
Other
A contactless patient monitoring complex has been invented
A complex equipped with sensors, cameras and thermal imagers for contactless monitoring of a patient's condition in a hospital and warning about apnea - breathing stops during sleep - was developed in Novosibirsk. The system is attached above the patient's bed and allows the doctor to receive data automatically in a short time, Igor Mendzebrovsky, Development Director of the Papillon company, told TASS journalists.
"The complex is a set of sensors - a thermal imager, depth cameras, light and air quality sensors and others. It collects a number of parameters from the patient, which we then interpret. We can evaluate a number of parameters that are important when military personnel are injured, how the condition changes in severe cases," he said.
The complex reads changes in body temperature, respiratory rate and respiratory movements of the chest and abdomen, pulse, body position, eye movement and facial expressions. It also determines the level of illumination and the content of carbon dioxide in the room.
The received data is processed using artificial intelligence (AI) technologies. The system allows informing medical personnel about the patient's condition and generating reports for the attending physician. "There are no contactless analogues," the developer emphasized. It is planned that the complex will automatically provide information about the apnea index - a short-term cessation of breathing during sleep, which can be associated with critical conditions for the body, such as a stroke. The technology is currently being tested at the Pirogov Hospital in Moscow.
Source: https://t.me/medicalksu/5790
New registered medical devices
We publish a list of new medical devices registered from 07.11.2025 to 07.18.2025
Link to the list: [see table in the attachment]
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