News Digest 08.09.2023-11.09.2023

Regulators

Methodological recommendations on the selection of medical devices with artificial intelligence technology for the subjects of the Russian Federation have been published

Key recommendations for acquiring MI with AI:

The acquisition and implementation of MI with AI should contribute to the achievement of the goals and objectives of the National Projects "Healthcare" and "Demography", in particular:

  • reduction of mortality of the able-bodied population from oncological and cardiovascular diseases;
  • increasing the availability of primary health care, including mass preventive medical examinations and screening studies.

The simplified procedure is extended to a laboratory blood gas analyzer for in vitro diagnostics, multiple blood gas analytes, hemoximetry and IVD electrolytes - reagents and control materials, a kit for mixing or injecting orthopedic cement. In addition to them, the list includes reusable compression socks and stockings.

The acquired MI with AI should belong to one of two types:

  • a device that interprets the data of radiation, laboratory or instrumental diagnostic methods. For example, search for zones, key points and contours of anatomical and pathological structures, calculation of linear and volumetric characteristics of structures, automatic generation of draft research protocols;
  • a product that interprets the data of an electronic medical record. For example, the identification of suspicions and risk factors, the prognosis of the development of the disease, the formation of tips to the doctor on further diagnosis and treatment tactics.

Source: https://portal.egisz.rosminzdrav.ru/materials/4401


Market news

Roszdravnadzor has registered another domestic medical device based on artificial intelligence technologies

There is a replenishment in the official list of domestic medical devices based on artificial intelligence technologies approved by Roszdravnadzor. The registration certificate for the software module for processing CT images of Sciberia Lungs was received by the Yakut developer of medical software "Cyberia". Now the company's solution can be used in medical organizations in Russia.

The company "Cyberia" quite often appears in the media. In particular, it is known that its solution is used in the Yakutsk City Hospital No. 3. Also, the company's developments were presented to the Chairman of the Government of Russia Mikhail Mishustin last year.

Source: https://t.me/news_mdr/6068


Other

Russian scientists have developed a new generation dental implant

Specialists of the Ural State Medical University of the Ministry of Health of Russia with colleagues from Tomsk State University have designed an implant and have already conducted a number of necessary tests. The development is based on the Mg-Ca-Zn alloy. The research results are published in the international journal Surface & Coatings Technology(Q1) The invention can be used:

  • In traumatology;
  • Orthopedics;
  • Maxillofacial surgery.

During the tests, experts confirmed that the material does not cause allergies and inflammatory complications, and also retains its properties for a long time. According to Ivan Gordienko, Vice-Rector for Research and Clinical Work at the UGMU of the Ministry of Health of the Russian Federation, work on improving the prosthetics system will continue.

Source: https://usma.ru/we-are-in-the-media/uchenye-iz-tomska-i-ekaterinburga-sovmestno-razotali-implant-novogo-pokoleniya/

Samara scientists are developing a non-drug method for the treatment of Parkinson's disease and cognitive impairment

Specialists of the Research Institute of Neuroscience of Samara State Medical University are conducting research to develop a non-drug method of treating Parkinson's disease using transcranial magnetic stimulation (TMS). The technique allows you to target nerve cells depending on the individual characteristics of the patient and thereby reduce the likelihood of side effects and increase the effectiveness of therapy.

To develop new methods of treatment, the specialists of SamSMU study the working memory of healthy people and the features of its violation in patients with neurodegenerative diseases. In 2022, scientists conducted a study among 30 healthy people. Now this experiment is being repeated with patients suffering from Parkinson's disease. In the future, such a study will be conducted for patients with vascular dementia. The research is carried out using modern neurophysiological research methods — high-density electroencephalography (EEG) and functional near-infrared spectroscopy (fBICS). The EEG registers the electrical activity of the brain, allowing you to diagnose disorders in its work. FBIX visualizes the activity of individual areas of the cerebral cortex by measuring blood oxygen saturation.

According to the results of the experiment, the scientists plan to create a model of the work of neurons that will correspond to cognitive disorders in Parkinson's disease and vascular dementia.

Based on the obtained model, scientists will develop a personalized non-drug treatment method using TMS.

Source: https://samsmu.ru/news/2023/08092/

News

News Digest 11.06.2026 — 19.06.2026
19.06.2026
Roskachestvo has identified issues with the registration and accuracy of blood pressure monitors; The Russian Ministry of Health has developed new instructions on how to handle citizen appeals; Revenue threshold for transition to VAT will be frozen until 2029
More
News Digest 05.06.2026 — 11.06.2026
11.06.2026
The Russian Government has amended the rules for maintaining the state register of medical devices; The Russian Ministry of Health has increased the number of medical specialties to 155; The Russian Government will allocate an additional 5 billion rubles for the purchase of glucose monitoring systems
More
News Digest 29.05.2026 — 05.06.2026
05.06.2026
The rule regarding the cancellation of registration of medical devices without an authorized representative is proposed to be postponed for a year; The Russian Ministry of Health has updated its procedures for monitoring the safety of medical devices and assessing their conformity; Amendments have been made to the Medical Device Safety Monitoring Procedure
More