News Digest 15.08.2025 — 22.08.2025
Regulators
Foreign manufacturers of medical devices have had their registration dossier updated postponed
The government has extended the opportunity to update registration dossiers for medical devices by one year. Foreign manufacturers must appoint authorized representatives by September 2026. The deadline for updating registration dossiers for medical devices has been postponed by one year. The Ministry of Health and Roszdravnadzor asked the associations of foreign manufacturers to do this. According to RF Government Resolution No. 1684 of November 30, 2024, foreign manufacturers of medical devices were required to include documents on the authorized representative of the manufacturer (ARM) in the registration dossier by September 1, 2025. This person must represent the interests of the manufacturer in Russia and be responsible for the circulation of medical devices (safety monitoring, analysis of post-registration clinical efficacy of medical devices). In the absence of information on the ARM, Roszdravnadzor had the right to cancel the registration dossier within 90 days. The government extended the update deadline until September 1, 2026.
Market news
Russian medtech earned almost 30 billion rubles in six months
According to the results of the first half of 2025, the Russian medtech market earned 27.6 billion rubles. The fastest growing segment was the device segment, while the largest segment - software development - showed a decline, according to the analytical report by Smart Ranking. Thus, revenue for devices increased by 41%, and for software development decreased by 10%. In addition, telemedicine continued to grow (+19%), its drivers are SberZdorovye, Doctis, as well as psychological services such as Yasno, Alter, SmartMental. In particular, SberZdorovye earned RUB 3.1 billion and took the leading line in the TOP of medical technology companies by revenue for the second quarter of 2025. In second place is the manufacturer of bionic prostheses Motorika, the company's revenue amounted to RUB 1.3 billion. The top three leaders of the rating are closed by the software developer Tsifromed, the company earned about RUB 1.1 billion. The TOP of fast-growing companies was headed by the manufacturer of bionic prostheses Steplife (699% year-on-year). The top three in this rating also included SberMedAI and the psychological center YouTalk. Revenue dynamics are 358 and 142%, respectively. Among the notable trends in the medical technology market, experts note companies' investments in their own digital ecosystems and IT infrastructure, the development of AI assistants, and the strengthening of partnerships. At the same time, the market is facing a lack of venture financing and stricter advertising requirements, which makes it difficult to launch new projects.
Source: https://medvestnik.ru/content/news/Rossiiskii-medteh-zarabotal-za-polgoda-pochti-30-mlrd-rublei.html
ECOlab invested 500 million rubles in expanding production in the Moscow region
ECOlab has commissioned a new production facility in Elektrogorsk, Moscow region. The total investment in the project amounted to almost 500 million rubles, as reported by the Minister of Investment, Industry and Science of the Moscow Region Ekaterina Zinovieva. Previously, the investment was estimated at 297 million rubles. According to Zinovieva, the company opened a sixth workshop, where medicines and medical products will be manufactured. As a result of the expansion, more than 50 jobs were created. In January 2025, the Main Directorate of State Construction Supervision of the Moscow Region reported that the new ECOlab building was 90 percent ready. At that time, the investment volume was estimated at 297 million rubles. The facility with an area of 4.5 thousand square meters was planned to be launched in the first quarter of 2025. It was supposed to produce up to 405 million units of packaged products annually. ECOlab produces diagnostic drugs, enzyme immunoassay test systems and other kits for in vitro research, as well as drugs for immunological and biochemical research. Diagnostic kits are supplied to various clinical diagnostic laboratories in Russia, medical devices - to the Republic of Belarus, Kazakhstan, Uzbekistan, Moldova, Armenia and Azerbaijan.
Other
NASA and Google are testing an AI doctor for astronauts
Regular assistance of artificial intelligence (AI) during colonoscopy reduces the ability of endoscopists to detect precancerous neoplasms without technology support. Such data was revealed by a study published in the journal The Lancet Gastroenterology & Hepatology. The frequency of detecting adenomas during colonoscopy without AI after the introduction of the technology fell from 28.4 to 22.4%. With colonoscopy using AI, the figure was 25.3%. According to the authors of the study, this is the first confirmation that routine work with artificial intelligence algorithms can lead to the loss of key clinical skills. Experts note that the rapid transition to digital assistants requires additional analysis in possible unintended consequences, including a decrease in the qualifications of medical personnel. Experts call for further research and more careful implementation of AI in clinical practice to prevent the erosion of professional competencies of endoscopists. AI helps to speed up and improve the accuracy of diagnostics, reduces the paperwork burden on doctors, contributes to the development of predictive models, and improves access to healthcare services in remote regions, experts say. The volume of the Russian AI market in healthcare reached 12 billion rubles in 2024, and is expected to grow to 78 billion rubles by 2030.
Glucotrack accelerates development of implantable glucose monitoring system American company
Glucotrack presented the results of the second quarter of 2025 and highlighted key progress in the development of a long-term implantable glucometer (CBGM). The device is implanted into the body and provides continuous monitoring of blood sugar levels without external sensors, and the service life of the sensor is up to three years. In the third quarter, the company will begin a CBGM clinical trial in Australia, and in the fourth quarter it plans to submit an application to the US Food and Drug Administration (FDA) to conduct a similar study. Leading endocrinologists have already shown interest in the technology: according to a survey, 73% of them are ready to prescribe CBGM to patients.
Source: https://t.me/vademecum_live/18889
The US has approved a cuffless blood pressure monitor for continuous blood pressure monitoring
The US Food and Drug Administration (FDA) in July 2025 granted approval for a cuffless blood pressure monitor that will be available without a prescription. The device, called Hilo Band, developed by the Swiss company Aktiia, is attached to the wrist and continuously monitors blood pressure using an optical sensor. For correct operation, the bracelet must be periodically calibrated using a classic blood pressure monitor with a cuff, as stated in the description of the device published by the FDA. Aktiia began selling Hilo Band in Europe in 2021, after receiving CE marking. The company plans to introduce the new product to the US market in 2026, which could significantly expand the availability of continuous blood pressure monitoring technologies for patients.
Source: https://t.me/vademecum_live/18868
New registered medical devices
We publish a list of new medical devices registered from 08.15.2025 to 08.22.2025
Link to the list: [see table in the attachment]
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