News Digest 06.02.2026 — 13.02.2026
Regulators
The regulator will change its approach to compiling the list of medical devices for the modernization of radiology departments
The Russian Ministry of Health has proposed updating the List of Medical Devices and Other Equipment Intended for Modernization, Retrofitting, or Refurbishment in Clinics Under the Executive Bodies of the Subjects of the Russian Federation and Providing Medical Care Using Radiological Methods. According to the published draft order, the structure of the list itself may be expanded by two columns.
In the current version of the document (Order No. 676n of November 18, 2025), the table consists of four columns: serial number, name of the medical device, its code, and type name according to the nomenclature. Currently, the table is being supplemented with two more columns: "Name of the Clinic's Structural Unit" and "Implementation Parameters."
For example, for a single-photon emission computed tomography (SPECT) scanner, the structural unit will be the SPECT room, and the implementation parameters will include the creation of a new department, refurbishment, retrofitting, and modernization. For a cadaver refrigerator (with an injected radiopharmaceutical drug), the structural unit will be the radionuclide therapy unit and the creation of a new department.
As in the previously approved order, the list will consist of 14 medical devices and 37 other equipment items. The list has been prepared in accordance with the current Procedure for the Provision of Medical Care to Adults with Oncological Diseases.
The decisive role of humans in AI decision-making will be enshrined in Russian legislation
Russia is preparing a law that will enshrine the priority of humans in the use of AI in socially significant areas – healthcare, education, legal proceedings, and public safety. The document is scheduled to be submitted to the Russian government for approval by the end of February.
The Russian government intends to limit the capabilities of artificial intelligence (AI) in decision-making in key social spheres. A provision on the "decisive role of humans" in the use of neural networks in healthcare, education, legal proceedings, and public safety is planned to be included in the law regulating this area, Izvestia reports.
This initiative is intended to reduce the risks of discrimination and algorithmic errors when using models trained on incomplete or biased data. Experts also point to the problem of "blurring of responsibility," when it is unclear who is responsible for the consequences of a decision – the developer, the system owner, or the user.
The document, prepared taking these comments into account, is scheduled to be submitted to the Cabinet of Ministers for approval by the end of February. It is expected to become the basis for further regulation of the use of neural networks in the Russian economy and social sphere.
The problem of insufficient regulation of AI in medicine is relevant for many developed countries. As Reuters has discovered, manufacturers are relaxing their quality standards to expedite the entry of AI-enabled medical equipment into the US market, while regulatory authorities are overwhelmed by the influx of approval applications. These factors combined make medicine more dangerous: at least two cases of stroke associated with AI-enabled medical devices have already been reported.
Market news
Samara is preparing to produce self-absorbing bone screws for osteosynthesis
Scientists at Samara State Medical University (SamSMU) have developed fundamentally new allogeneic bone screws for traumatology and orthopedics. This technology could change the standard of treatment for fractures and complex injuries, eliminating the need for repeat surgeries, the university's press service reported.
The innovative product, called "Lioplast-Screw," is intended for osteosynthesis—the surgical connection of bone fragments in traumatology, orthopedics, and maxillofacial surgery. Unlike titanium screws, allogeneic screws do not require repeat surgery for their removal after bone healing; over time, they completely dissolve and are replaced by the patient's bone tissue.
The safety of the product is ensured by careful monitoring of the donor material, multi-stage processing that removes potential antigens, and final radiation sterilization. To this end, specialized CNC machine programs were developed and patented that convert the 3D screw model into commands with micron accuracy.
The project is being implemented with a grant from the Foundation for the Support of Technological Entrepreneurship. A pre-production batch of products is already ready, and the technological package is fully developed for production. Biological and clinical trials are planned for 2026 to obtain a registration certificate from Roszdravnadzor.
Other
Manufacturers' rush to introduce AI could make medical equipment more dangerous
Proponents of AI in medicine believe that artificial intelligence (AI) will help develop new drugs, speed up diagnostics, reduce doctors' workload, and protect surgeons from errors. However, a Reuters review found that manufacturers of AI-enabled medical devices (MDs) are rushing to bring their products to market, neglecting patient safety. At least two cases of stroke have been reported during AI-guided procedures.
In 2021, Acclarent (a division of Johnson & Johnson) announced the integration of AI into the TruDi sinusoplasty device. Machine learning algorithms were used to navigate the sinuses during the procedure. At least ten people have been injured after the AI was integrated into the device, according to reports from the US Food and Drug Administration (FDA):
- One patient experienced a cerebrospinal fluid leak from the nose;
- in another case, a surgeon mistakenly punctured the base of the skull;
- two patients suffered strokes and sued Acclarent, with one surgeon damaging their carotid artery after being misled by the navigation system.
The company claims it did not develop or manufacture the TruDi system, but merely distributed it. However, one of the surgeons stated that he warned Acclarent of the risks. The company subsequently relaxed its safety standards, setting the AI technology's accuracy at 80% sufficient for implementation.
FDA reports on medical device failures do not allow for proving a causal link between patient harm and the use of AI-enabled devices. The documents often lack detail and are redacted to protect trade secrets. This was stated by Integra LifeSciences, which acquired Acclarent in 2024.
At least 1,357 AI-enabled medical devices have already been approved in the US. This is twice the number of applications in its entire history up to 2022, and the FDA is struggling to cope with the influx of applications. In 2025, the agency laid off a third of its staff (some of whom quit voluntarily) testing algorithms in various clinical situations. The layoffs were related to the policies of the Office of Government Effectiveness (DOGE), created by Elon Musk. This has complicated the FDA's work, agency sources told Reuters.
In Russia, oversight of AI-enabled medical devices was tightened in 2025. Roszdravnadzor (the Federal Service for Surveillance in Healthcare) required manufacturers to transmit error data on AI-enabled medical devices to an automated information system for real-time monitoring of the effectiveness and safety of the equipment. Previously, the Russian Ministry of Health developed a Code of Ethics for the Use of Artificial Intelligence at All Stages of its Development and Application.
Taiwanese authorities will offer citizens "health coins" for vaccinations and cancer screenings
The Taiwanese government is preparing to launch a "health coin" rewards system, which will be integrated into the government-run My Health Bank national health insurance app. Users will be able to earn digital rewards for vaccinations, medical checkups, and cancer screenings and spend them on healthy eating, soft drinks, and fitness services from program partners, including insurance companies, convenience stores, health monitoring apps, and sports brands, according to Deputy Minister of Health and Welfare Chuang Chen-hsiang, according to the Taiwanese newspaper Taipei Times.
The national "health coin" system will be launched this year. This initiative is part of a broader program to encourage preventive care: Taiwan's Ministry of Health previously announced a system of "health points" for vaccinations, medical checkups, and cancer screenings, which can be exchanged for healthy lifestyle products and services. The mechanism relies on the National Health Insurance (NHI), which covers approximately 99% of the population and is actively used as a platform for incentive programs and immunization.
In 2011, ten US states, under the Medicaid Incentives for the Prevention of Chronic Diseases (MIPCD) program, offered cash and in-kind rewards (cards, vouchers) for participation in preventive programs and behavioral changes, such as smoking cessation, weight loss, and blood pressure and sugar control. Financial incentives for preventive care are also currently in place in the country.
In Europe, health insurance companies are also facing the challenge of motivating clients to prioritize prevention over treatment. Most preventive programs offer discounts on gym memberships and send reminders for annual medical checkups, but only 23% of Europeans actively participate in employer-sponsored wellness campaigns. Therefore, digital "health coins" have also been introduced in Europe.
In Russia, a number of programs aimed at promoting a healthy lifestyle are in place. For example, a social tax deduction for sports activities was introduced in 2022: you can recoup a portion of the money spent on memberships and training sessions at accredited organizations. The "Active Longevity" and "Older Generation" programs are being implemented, along with regional practices that provide conditions for sports and rehabilitation for the elderly.
In 2021, amid the COVID-19 pandemic, lotteries and prize draws were held among those vaccinated against the coronavirus: Renault Logan cars were raffled off in Moscow, and apartments were given away in the Moscow region. The federal vaccination lottery offered cash prizes of 100,000 rubles to 2,000 winners. However, a sustainable "health points" system is not yet in place in the country.
An AI translator for medical forums and conferences has been developed in Russia
Medtech company Lab4U announced to Vademecum that it has developed and presented Russia's first real-time medical translator and prompter powered by artificial intelligence (AI). The platform is positioned as a web service for events, meetings, and broadcasts that converts live speech into text and translates it in real time without installing additional software. A pilot implementation of the solution took place at the 12th All-Russian Priorov Forum on Traumatology and Orthopedics.
The Lab4Speak system runs directly in the browser: a microphone or system audio can be connected to the service, after which a transcription and translation into the selected languages is generated for display on the hall screen, in an online broadcast, or on participants' devices via a link or QR code. It supports multiple languages simultaneously and supports custom glossaries for more accurate rendering of medical terminology, drug names, and professional abbreviations.
To improve stability during lengthy presentations and two-way discussions, the developers refined the context management mechanism, improving translation accuracy in real time. The model was trained on extensive medical and scientific texts, materials from specialized forums, and professional documents related to the event's topic. Both publicly available sources and materials on medical terminology recommended by the Ministry of Health were used.
The platform supports the creation of parallel rooms and separate language channels for sections and workshops, as well as a two-way communication mode for bilingual discussions. At the end of sessions, the system automatically generates summaries of presentations, expanded summaries with key points, and final reports. A Telegram bot is available for further processing of the materials.
New registered medical devices
We publish a list of new medical devices registered from 02.06.2026 to 02.13.2026
Link to the list: [see table in the attachment]
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