News Digest 06.11.2026 — 13.11.2026
Regulators
CNIIOIZ Presents Methodological Guidelines for Implementing AI-Powered Medical Devices
The Central Research Institute for Health Organization and Informatics (CNIIOIZ) of the Russian Ministry of Health has developed methodological guidelines for the implementation of medical devices that utilize artificial intelligence (AI) technologies. The document covers two categories of devices: those that process diagnostic imaging results via central medical image archives (CMIA) and those that work with data from integrated electronic medical records (IEMR). The guidelines provide a "roadmap" for implementing such solutions, outline safety requirements, and offer various recommendations for their operation.
The document is intended for healthcare administrators and applies specifically to the use of state information systems within the constituent entities of the Russian Federation. According to the authors, the implementation process can be carried out by medical organization staff, the developers of the medical devices, or their partners.
The implementation plan consists of three stages: first, preparation (forming a working group, defining measurable goals, creating a "project passport," and auditing infrastructure and personnel); second, installation, configuration, and user training, followed by an assessment of user competency; and third, pilot-to-production operation. During this final stage, the AI’s output is not necessarily used in actual clinical practice immediately; rather, it serves as a trial period, concluding with the issuance of a formal document confirming the system's readiness for full-scale operational deployment.
For devices that process diagnostic imaging results via a CMIA, the authors propose five implementation scenarios: centralized (AI integrated into the regional state information system), decentralized (AI installed at the level of an individual medical organization), hybrid, and two options utilizing the "MosMedAI" platform—either as a standalone solution or in conjunction with a regional state information system. Three scenarios are outlined for the implementation of medical devices designed to work with the Integrated Electronic Medical Record (IEMR) system: sending anonymized patient data to an AI system to create a digital profile; providing decision support based on that profile; and offering support based on a specific electronic medical document.
Architectural recommendations include keeping medical images at their point of origin—such as in a local archive—while using a Centralized Medical Imaging Archive (CMIA) to facilitate search, routing, and access. According to the authors, this approach reduces the load on communication channels, eliminates redundant storage costs, and maintains centralized management of medical examinations.
Russian Ministry of Health Clarifies Procedures for Electronic Waybills for Medical Waste Transport
New regulations for electronic transport waybills, which took effect on September 1, 2026, also apply to the removal of medical waste. In the absence of a separate contract, a waybill—either in paper or electronic format (submitted to the relevant state information system)—must be issued for every vehicle used.
These new rules for electronic transport waybills apply to the removal of Class B, C, and D medical waste. Further details are provided in a letter from the Russian Ministry of Health (No. 30-5/3602, dated September 2, 2026), which has been published in the "Consultant" legal database.
The regulatory authority notes that a transport waybill is required for the removal of medical waste whenever the transport is carried out under a formal freight carriage agreement. In accordance with Federal Law No. 140-FZ of June 7, 2025, starting September 1, 2026, such waybills must be generated in electronic format and submitted to the State Information System for Electronic Transport Documents (GIS EPD).
If no separate contract for the transportation of medical waste is concluded—and the removal is instead carried out under a broader contract covering various services related to the management of medical waste—the owner or operator of the vehicle is required to issue a waybill, either in paper or electronic form. A waybill must be prepared for each individual vehicle and must also be submitted to the GIS EPD. These requirements apply to all types of cargo transport, including urban, intercity, and suburban routes.
Market news
Medpribor Acquires Russian Partner of Siemens Healthineers
St. Petersburg-based JSC Medpribor—affiliated with the Central Medical Base (CMB) group of companies and the ICLINIC network—has acquired VTS LLC, a major Russian supplier of medical equipment and an official business partner of Siemens Healthineers in Russia, as reported by *Kommersant*. According to the SPARK database, the deal was closed on October 19, 2026.
Since 2003, VTS has been supplying and servicing CT, MRI, and ultrasound systems across Russia. In 2025, the company reported revenue of 1.67 billion rubles and a net profit of 346 million rubles. Technical maintenance and repair of medical equipment accounted for 431.7 million rubles, or approximately one-quarter of the company’s total revenue.
For the CMB group, this acquisition strengthens its capabilities in the comprehensive outfitting of medical facilities. The group will now be able to offer an integrated package covering the supply, commissioning, and maintenance of diagnostic equipment.
CMB is a distributor of pharmaceuticals, medical devices, and equipment. The group also operates 14 ICLINIC medical centers in St. Petersburg and Kaliningrad.
Source: https://medvestnik.ru/content/news/medpribor-kupil-rossiiskogo-partnera-siemens-healthineers.html
Global Market for Computer-Assisted Surgery Systems Projected to Nearly Triple by 2034
The global market for computer-assisted surgery systems was valued at $13.88 billion in 2025. According to a forecast by the consulting firm Fortune Business Insights, the market is expected to reach $37.76 billion by 2034—an increase of nearly threefold. The average annual growth rate from 2026 to 2034 is projected to be 11.4%.
Computer-assisted surgery systems integrate robotics, navigation, visualization, digital planning, tracking, and computer-controlled instrumentation. They assist surgeons in planning and performing operations with greater precision, enhancing the reproducibility of procedures, and facilitating minimally invasive approaches. Such technologies are utilized in general surgery, orthopedics, spinal surgery, neurosurgery, urology, and gynecology.
The primary market driver is the increasing number of robotic and minimally invasive interventions; these platforms improve visualization, scale movements, filter out tremors, and ensure precise control of surgical instruments. Furthermore, the market is bolstered by hospital investments in modern operating rooms, surgical navigation systems, and digital preoperative planning.
Other
An electrostimulation-based comb has restored nearly 100% of hair in mice with androgenetic alopecia
A research team from Beihang University in China has developed a bioelectronic system called "Detangle"—a comb-like device designed to treat the scalp during routine brushing. The device features tines equipped with electrodes of varying heights, along with integrated modules for loading therapeutic molecules. This design generates an electric field with an intensity of approximately 260 V/m—2.63 times stronger than that produced by electrodes of uniform height—and enables the delivery of substances to the hair follicle region at a depth roughly nine times greater than that achieved through conventional topical application.
The therapeutic effect relies on a combination of electrostimulation and the delivery of regulatory molecules via electroporation. The system introduces a plasmid encoding vascular endothelial growth factor A (VEGFA) into the follicle cells, alongside an siRNA molecule targeting the *SRD5A2* gene. The former stimulates angiogenesis (the formation of new blood vessels) around the follicles, while the latter suppresses the synthesis of dihydrotestosterone—the primary androgen responsible for hair loss.
Experimental validation demonstrated that the system can deliver surface-applied molecules to a depth of approximately 660 μm within the skin in just one second—significantly deeper than both conventional topical application (about 74 μm) and the use of electrodes of uniform height (about 250 μm). The induced transmembrane potential exceeds 0.7 V, a level sufficient to facilitate effective electroporation and the entry of molecules into the follicle cells. In experiments on mice, the electrical parameters used were 30 V, a pulse duration of 1 ms, a frequency of 10 Hz, and 100 pulses per session. Treatment was administered every three days.
In an experiment using a mouse model of androgenetic alopecia, the group receiving electrical stimulation showed significantly more robust hair growth: hair coverage reached 39.52 compared to 0.90 in the control group, and the hair growth cycle score was 2.60 versus 0.60. The number of hair follicles increased to 151, compared to 49.5 in the non-stimulated group. Additionally, there was an increase in local blood flow, a rise in the number of blood vessels, and a 5.80-fold increase in the expression of CD34—a marker for follicle activation. Combined therapy involving the delivery of VEGFA and SRD5A2 siRNA restored nearly 100% of hair coverage within one month, whereas standard topical treatment with minoxidil in the same model yielded approximately 70% recovery.
The safety of the system was evaluated at the epidermal, cellular, and molecular levels; no significant changes in body weight or levels of inflammatory markers were observed, nor were there any signs of damage to cells or nerve tissue. Repeated application to the same area of skin did not trigger any notable adverse reactions. Mechanistic analysis revealed that electrical stimulation enhances the expression of the PGM3 protein, which activates the Wnt/β-catenin signaling pathway—a pathway that plays a key role in hair follicle regeneration. The authors conclude that "Detangle" represents a non-invasive strategy combining electrical stimulation and electrophoresis, which could improve the efficacy of treatment for androgenetic alopecia.
New registered medical devices
We publish a list of new medical devices registered from 11.06.2026 to 11.13.2026
Link to the list: [see table in the attachment]
News
