News Digest 24.04.2024 — 27.04.2024
Regulators
Roszdravnadzor intends to cancel the regulations on receiving notifications in the field of circulation of medical devices
Roszdravnadzor plans to invalidate the order No. 3239 dated April 25, 2019, approving the administrative regulations for the reception and recording of notifications about the start of activities in the field of circulation of medical devices. The rules for submitting notifications were previously changed by the government by its decree: now documents must be submitted through the government services portal.
Market news
Russian companies, amid problems with making payments in China, began to resort to the services of intermediaries from the UAE, Kazakhstan, Kyrgyzstan and other “friendly” countries
Two consultants from Russia who work with intermediaries said that half of the companies experiencing payment difficulties use such services.
According to them, many companies, including those sanctioned, established intermediation schemes a year ago. According to one consultant, about 20% of Russian firms have full access to their bank accounts in China, while another 30% have limited access.
An unnamed Russian textile company reported successful experience using an intermediary: with its help, it opened an account in China and transferred funds from Kyrgyzstan.
Source: https://www.rbc.ru/economics/27/04/2024/662ca9879a794763a43134f8
An offset contract for the production of test strips for glucometers will be concluded in the Primorsky Territory
The Primorsky Territory Public Procurement Center posted an application on the official government procurement portal for concluding an offset contract for localizing the production of test strips for Gmate Life analyzers in the region. The initial contract amount is 1.38 billion rubles.
The tender involves the creation, modernization and development of reagent production in the Primorsky Territory. It is expected that under the contract from 2025 to 2033, the region will purchase 85 million test strips for Gmate Life glucometers. 5 million test strips will be supplied in 2025, then 10 million annually for eight years.
In France, a device has been developed to measure four health indicators
French health device company Withings has developed the BeamO multiscope to measure four health parameters. The device can measure body temperature, blood oxygen levels, heart and lung sounds. In addition, BeamO detects abnormal heart rates and detects atrial fibrillation. The device sends all information to the user’s phone.
In 2024, Withings plans to clinically validate the device and receive CE (European Conformity) marking and US Food and Drug Administration approval. They plan to sell the multiscope for $250.
Source: https://t.me/vademecum_live/12684
Other
LG, Microsoft and GE HealthCare will create hospitals of the future in South Korea
Three technology giants will join forces to create a smart hospital project in South Korea, Mobihealthnews reports. LG will provide smart monitors and org. technology, Microsoft - artificial intelligence technologies and cloud infrastructure, GE HealthCare will provide the latest developments in the field of medical equipment.
Source: https://t.me/medicalksu/4973
The developer of AI solutions for facial recognition received a RU for the use of technology for diagnosing strokes
NtechLab, which develops systems based on artificial intelligence (AI) technologies in the field of security and facial recognition, has received permission to use the NTechMed CT Brain medical decision support system (MDS) for diagnosing ischemic and hemorrhagic stroke based on computed tomography images.
The software can be used in Russian clinics to analyze brain CT images taken in DICOM format, as well as automate routine measurements when diagnosing patients with acute cerebrovascular accident.
New registered medical devices
We publish a list of new medical devices registered from 04/19/2024 to 04/27/2024
Link to the list: [see. table in attachment]
News
