News Digest 02.10.2026 — 09.10.2026
Regulators
The Government has updated the point-based system for assessing the localization of medical devices
The Russian Government has amended Resolution No. 719 (dated July 2015), which regulates the procedure for confirming the manufacture of industrial products within Russia. The resolution was signed by Prime Minister Mikhail Mishustin. The new document tightens requirements for the localization of medical device production. The amendments update the criteria for confirming Russian origin for a wide range of products, including implants, prostheses, consumables, laboratory reagents, and others. The minimum threshold for recognizing products as Russian-made will be raised in stages through 2031. The amendments will come into force 10 days after publication.
Changes to the annex of Resolution No. 719, "On Confirming the Production of Russian Industrial Products," update localization criteria for dozens of types of medical devices. These include osteosynthesis implants, joint endoprostheses, limb and blood vessel prostheses, cochlear implant systems, hearing aids, dental instruments, vacuum blood collection tubes, in vitro diagnostic reagent kits, wheelchairs, orthopedic footwear, and many others. In total, Section VII ("Medical Devices") will be expanded to include nearly 100 additional items.
The document also approves new lists of technological operations required to confirm the Russian origin of products. For each product category, the resolution specifies the production processes and the use of domestic components and materials that earn localization points. Specifically, the criteria take into account the manufacture of blanks, machining and heat treatment, casting, molding, assembly, coating application, and sterilization, as well as the use of raw materials and components produced within the territories of Eurasian Economic Union (EAEU) member states. Mandatory conditions include holding valid rights to technical documentation for a period of at least five years; preparing design and manufacturing documentation in accordance with the Unified System for Design Documentation and the Unified System for Technological Documentation standards; possessing a registration certificate specifying a manufacturing address within the Russian Federation; and complying with the GOST ISO 13485-2017 standard.
Furthermore, the document establishes minimum point thresholds required for products to be recognized as Russian-made. For the majority of medical devices, these requirements will increase in stages between 2026 and 2031. For instance, between 2026 and 2029, the threshold will rise from 50 to 70 points for uncoated polymer or ceramic osteosynthesis implants (including instruments); from 80 to 140 points for limb joint endoprostheses made of steel and alloys (including instruments and coatings); and from 120 to 230 points for upper and lower limb prostheses featuring functional components and cosmetic coverings.
Compliance with all requirements set forth in Resolution No. 719 is necessary for manufacturers to participate in public procurement and access specific state support measures in the Russian Federation.
Market news
Helix Opens Automated Laboratory Complex in Moscow Worth 4.8 Billion Rubles
The Helix Group has launched a new laboratory complex covering an area of 10,000 square meters. The project involved an investment of 4.8 billion rubles. Its stated processing capacity is up to 300,000 tests per day. According to the owners, the complex is capable of performing a full spectrum of analyses. The laboratories are equipped with machinery from Swiss-based Roche Diagnostics, US-based Beckman Coulter, and China’s Mindray; Russian manufacturers DNA-Technology and Vector-Best; and systems developed by Labomatix, a subsidiary of the Helix Group.
Company representatives stated that the complex features a world-first equipment configuration comprising two autonomous processing lines and vertical track systems from Roche. Helix notes that these vertical tracks allow for the movement of biological samples between the complex's floors, significantly boosting operational efficiency. The Roche production lines are fully automated and capable of processing over 130,000 tests daily.
The complex also utilizes equipment from Beckman Coulter, Mindray, DNA-Technology, and Vector-Best. Furthermore, it houses the world’s first automated system for the pre-analytical stage: incoming biological samples are loaded into automatic sorters that handle test tubes and other types of containers. This technology was developed by Labomatix, part of the Helix Group.
The new Helix complex will serve as a clinical trial center for testing and launching new equipment and reagents from both domestic and international manufacturers onto the Russian market. It opened at the Neopolis business district in the southwest of the capital and simultaneously became the company's Moscow office.
Other
Virtual patients to help identify medical device risks missed by conventional studies
Researchers from the University of Manchester, in collaboration with the regulator MHRA, have presented a framework in the journal *Device* that makes computer simulations—or *in silico* methods—sufficiently reliable for regulatory decisions regarding the safety and efficacy of medical devices. Digital evidence is intended to complement, not replace, laboratory, preclinical, and clinical studies.
Traditional medical device testing relies on laboratory experiments, animal studies, and clinical trials. However, bench and animal data do not always predict how a device will behave in the human body, and clinical studies often underrepresent women, ethnic minorities, pregnant individuals, and children. Published estimates suggest that only about three out of ten new high-risk devices tested on humans reach the US market, and among devices that progress to major pivotal trials, approximately four out of ten fail to gain approval. Computer models of virtual patients, based on real anatomy, can help bridge these gaps but must supplement rather than replace laboratory and clinical data.
The proposed framework selects potential types of harm based on three criteria: relevance to a specific regulatory decision; the existence of a plausible causal link between a design change and the harm; and the modeling's ability to provide evidence that complements or extends bench and clinical studies. For each selected harm, the framework assesses the extent to which the regulatory decision relies on the model and the severity of the consequences should an error occur.
This determines the depth of model validation required: the correctness of its construction, its alignment with real-world measurements, and the certainty of its predictions—including the impact of assumptions and natural patient variability. The authors believe this risk-based approach helps manufacturers generate reliable digital evidence and facilitates the international acceptance of such data. The framework was tested using a hypothetical example involving the redesign of a transcatheter aortic valve implantation (TAVI) device. Modeling was applied to three scenarios: valve deployment and seating, the impact on cardiac electrical signals, and paravalvular leakage. The model indicated a medium-to-high risk for the first two scenarios and a medium risk for the third, necessitating both bench and clinical validation. According to the authors, this approach fosters safe innovation, reduces development costs, expands patient access to new technologies, and—in the long term—enables smaller clinical trial cohorts through the justified incorporation of digital evidence.
FDA Approves First-of-Its-Kind Size-Adjustable Pediatric Heart Valve
The U.S. Food and Drug Administration (FDA) has approved the Autus heart valve from Edwards Lifesciences, the first size-adjustable pediatric heart valve of its kind. This new surgical pulmonary heart valve is designed for children with congenital heart disease. According to the manufacturer, a key feature of the device is its ability to expand as the child grows, thereby reducing the need for repeat open-heart surgeries.
According to FDA data, the Autus valve measures 13 mm at initial implantation—a size corresponding to the heart valve diameter of toddlers and preschool-aged children. Over time, the device is expanded via a minimally invasive transcatheter procedure using a balloon catheter. Ultimately, the valve can reach a maximum size of 22 mm, comparable to the diameter of an adult pulmonary valve.
Furthermore, Autus is the first valve with polymer leaflets to receive FDA approval. Traditionally, such devices are made from animal-derived tissues, which, according to the regulator, tend to harden and degrade more quickly within the body. Consequently, the FDA granted the Edwards device "breakthrough device" status. Autus also became the first pediatric medical device to receive approval under the FDA’s Total Product Life Cycle Advisory Program.
According to the FDA, congenital heart defects are among the most common types of birth defects in the U.S., affecting approximately one in every 100 newborns. Such conditions include pulmonary valve anomalies—specifically pulmonary valve stenosis, where the valve is narrowed, and pulmonary valve atresia, where the valve fails to form properly; both conditions restrict blood flow from the heart to the lungs. According to the Centers for Disease Control and Prevention, pulmonary valve atresia and stenosis combined affect approximately 4,200 infants in the United States each year.
Nobel Prize in Medicine Awarded for the Development of Optogenetics
The 2026 Nobel Prize in Physiology or Medicine has been awarded to Karl Deisseroth of the Howard Hughes Medical Institute and Stanford University (USA), Peter Hegemann of Humboldt University (Germany), and Georg Nagel of the University of Würzburg (Germany). The prize recognizes discoveries related to light-sensitive ion channels and the development of optogenetics—a method that uses light to control the activity of nerve cells and study brain function.
The prize amount is 12 million Swedish kronor ($1.2 million). This sum will be shared equally among the three scientists.
Work on the method began with research conducted by Peter Hegemann and Georg Nagel. In the early 2000s, the scientists studied the single-celled alga *Chlamydomonas*, which is capable of moving toward a light source. They discovered a protein called channelrhodopsin in its cell membrane that forms an ion channel. When exposed to blue light, the channel opens, allowing charged particles to pass through and generating an electrical impulse within the cell.
The researchers established that transferring the gene encoding channelrhodopsin into other cells made them sensitive to light. This discovery enabled the use of the protein as a tool to control the electrical activity of cells.
Karl Deisseroth applied this principle to rat nerve cells. In 2005, he demonstrated that blue light could be used to activate neurons containing channelrhodopsin. In 2007, he successfully utilized this light-controlled switch directly within the brains of living mice. The developed approach has been named "optogenetics." This method has enabled researchers to study the functioning of specific neural circuits with high precision and to establish causal links between nerve cell activity and behavior. Previously, brain research methods primarily allowed for correlating the activity of specific regions with particular functions but did not offer a way to directly test for causality.
Using optogenetics, scientists investigate neural circuits associated with memory formation, emotions, and various behavioral patterns. This facilitates, among other things, the study of the mechanisms underlying neurological and psychiatric disorders. Furthermore, the method is being applied in clinical research: scientists are exploring the potential of using the optogenetic approach to restore vision in individuals with visual impairments.
According to the Nobel Committee for Physiology or Medicine, the development of optogenetics laid the foundation for a new era of brain research, enabling the study of brain function through the controlled manipulation of individual nerve cells and neural circuits.
New registered medical devices
We publish a list of new medical devices registered from 10.02.2026 to 10.09.2026
Link to the list: [see table in the attachment]
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