News Digest 29.08.2025 — 05.09.2025
Regulators
Bionic prostheses included in the "second extra" list
The Russian government has added 11 new types of prostheses to the "second extra" list for public procurement, including feet, knee, hip and elbow modules, as well as hand units, including those with microprocessor control. In addition, for some products, including medical furniture, surgical clothing, gauze products, the use of the ST-1 certificate has been extended until the end of 2025. A transition period has also been introduced into the national regime for medical products included in the register without specifying points before the entry into force of the localization point assessment. This period will last until the end of 2026.
The "second extra" establishes protectionist measures for domestic products in public procurement: if at least one offer with an EAEU product appears in the tender, all offers with imported products are automatically rejected.
The changes were introduced by Government Resolution No. 1326 of August 29, 2025. In particular, 11 new items were added to Appendix No. 2 to PP No. 1875, which regulates protectionist measures for products from the EAEU in public procurement: polyurethane and composite foot, knee modules with mechanical, pneumatic and hydraulic, as well as microprocessor control, hip modules, passive and active hand units, including those with microprocessor control, as well as a passive elbow unit.
For medical products made of gauze and medical clothing, including disposable surgical kits, medical furniture, the possibility of validating the country of origin based on the ST-1 certificate has been extended until December 31, 2025. Previously, the deadline expired on August 31, 2025.
Source: https://vademec.ru/news/%3E/news/2025/09/02/bionicheskie-protezy-popali-v-perechen-vtoroy-lishniy/
The schedule for creating megascience facilities and nuclear medicine complexes will change
The Ministry of Education and Science of the Russian Federation presented a draft government resolution with amendments to the Federal Scientific and Technical Program for the Development of Synchrotron and Neutron Research and Research Infrastructure. The adjustments concern the timing of projects to create unique megascience facilities and nuclear medicine and hadron therapy complexes.
According to the project, the completion of design and survey work on the creation of a "fundamentally new promising source that surpasses the existing and planned international sources of synchrotron radiation in technical characteristics" in Protvino, Moscow Region, will be postponed from December 2025 to December 2026. The deadlines for the delivery of technological equipment and the completion of construction work have also been changed - from September and December 2032 to 2035. Commissioning of the facility has been shifted to the end of 2036.
The changes also affected the creation of a prototype of a standard domestic clinical center for ion (carbon) therapy "LUCH-TYPE-ION". The delivery of equipment and the completion of construction and installation work are planned to be postponed from 2030 to 2031. The completion of work on creating a prototype may also be shifted by a year. The commissioning of the project is scheduled for the end of December 2031, the registration of the medical device is planned for the end of 2032.
The commissioning date of the LUCH-OKO onco-ophthalmological complex remains fixed at December 2025. However, it is assumed that obtaining a registration certificate for the medical device will be postponed from December 2026 for another year. It is also proposed to postpone all activities for the creation of a radioisotope complex for obtaining a wide range of radioisotopes for the diagnosis and therapy of oncological, cardiovascular, neurological and ophthalmological diseases "IZOTOPE". The commissioning of the facility, according to the draft resolution, will take place in December 2026.
Market news
An updated version of the domestic ECMO device Ex-Stream is getting ready to enter the market
A new version of the first Russian extracorporeal membrane oxygenation (ECMO) device Ex-Stream is getting ready to enter the market. The development allows for prosthetic heart and lung functions for various indications: cardiopulmonary failure, sudden cardiac death, operations in high-risk patients and donation.
Source: https://t.me/vademecum_live/19069
The simulator of the developers of Samara State Medical University for diagnosing balance disorders received a regulatory certificate
The ReviStabix simulator, developed at the Institute of Innovative Development of Samara State Medical University, is designed to diagnose balance disorders and to restore motor activity, balance and coordination of movements.
The technology was created for the treatment and rehabilitation of patients after acute cerebrovascular accidents, neurosurgeries, traumatic brain injuries, joint replacement. The simulator can also be used after lower limb prosthetics, at different stages of rehabilitation and training in the use of a permanent prosthesis. In addition, it can be used to develop individual patient rehabilitation programs with a gaming component.
According to Sergey Chaplygin, Director of the Institute for Innovative Development and the Federal Center for Technology Transfer in Medicine at Samara State Medical University, ReviStabix is a high-tech rehabilitation complex that fully complies with the import substitution strategy and was created jointly with leading industry experts.
This year, the developers have planned the serial production of ReviStabix.
Source: https://t.me/vademecum_live/19050
The domestic hydrogen analyzer Gastro One was issued a registration certificate
The Russian hydrogen analyzer Gastro One received a registration certificate. It is designed to study the syndrome of excessive bacterial growth (SIBO) in stationary conditions. The developers were a multidisciplinary team of scientists from Sechenov University, Moscow State University. M. V. Lomonosov and Izhevsk Radio Plant. They claim that the device has become the first such analyzer registered in Russia.
It is based on a highly sensitive sensor for measuring hydrogen in exhaled air, consisting of domestically produced components.
SIBO is a disease characterized by a violation of the composition of the small intestine microbiota, changes in intestinal motility, and the development of malabsorption. It is accompanied by a violation of the local and systemic immune response.
At the moment, about 23 million patients in Russia need monitoring of this condition. The most common method for diagnosing SIBO is a non-invasive hydrogen breath test. The new development will help increase the availability of disease diagnostics and the effectiveness of medical care.
The developers also plan to release a portable version of the device that patients can use at home. The device was developed during the implementation of the Priority 2030 program and the Clinic Without Borders strategic technology project.
Source: https://t.me/vademecum_live/19044
Other
Scientists have developed a stethoscope with AI to detect heart disease in 15 seconds
Specialists from Imperial College London, together with Eko Health, have presented a new generation stethoscope with artificial intelligence, capable of diagnosing heart failure, heart valve disease and arrhythmia in 15 seconds.
The device analyzes the smallest deviations in heart rhythm and blood flow, and also simultaneously performs an express ECG. The data is sent to the cloud, where AI algorithms determine the risks and return the result to the doctor's smartphone.
A study involving 12,000 patients from 200 British clinics found that the use of a stethoscope with AI made it possible to detect heart failure twice as often, atrial fibrillation three times more often and diagnose heart valve disease almost twice as often.
According to scientists, a "smart" stethoscope can significantly speed up diagnosis and help prescribe the necessary treatment at an early stage, when the disease has not yet progressed to a severe form, which will reduce the number of hospitalizations.
At the same time, the researchers emphasize that the technology is not intended for mass screening of healthy people and should only be used in patients with suspected heart pathologies, since there is a high probability that people will be misdiagnosed.
Source: https://t.me/vademecum_live/19027
A device for daytime sleep apnea therapy has been created in the UK
Signifier Medical Technologies has introduced the eXciteOSA device, which offers a new approach to the treatment of mild obstructive sleep apnea. The device is used during the day and affects the cause of the disease using neuromuscular electrical stimulation.
Clinical studies have shown that the use of the device can reduce the apnea-hypopnea index (AHI) to 52% and achieve a level of adherence to therapy of more than 80%. According to Professor Akhil Tripathi, one of the authors of the development, the idea was to create an alternative to cumbersome and inconvenient night treatments that often interfere with sleep.
Today, eXciteOSA is used by more than 10 thousand patients. The manufacturer plans to expand cooperation with medical organizations to make the device available to a wider audience.
Source: https://t.me/vademecum_live/19084
New registered medical devices
We publish a list of new medical devices registered from 08.29.2025 to 09.05.2025
Link to the list: [see table in the attachment]
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