News Digest 20.09.2023-21.09.2023
Regulators
GOST for AI services in medicine came into force in Moscow
Developed with the participation of Moscow radiologists, GOST, necessary for the safe design and maintenance of artificial intelligence systems in clinical medicine, has come into force.
The new GOST is already the 11th standard for testing artificial intelligence created in Russia; it has no analogues in the world. The document defines the requirements for each process in the life cycle of artificial intelligence systems. The use of standards will ensure the implementation of only proven, reliable solutions in practical medicine, will help in the development of new neural networks and testing of existing ones.
It is noted that the new standard complements the existing GOST IEC 62304-2022.
Source: https://ria.ru/20230920/ii-1897449499.html
Market news
In Russia, disruptions began in the supply of products for the treatment of diabetes in children
In Russia, the availability of continuous glucose monitoring (CGM) in patients with diabetes has decreased. Some of the components for this system were included in the restrictive list published by the United States in May 2023, and now their import into Russia is difficult.
Sensors from Medtronic have become unavailable. Chinese systems are inadequate, and Abbott's remaining products on the market are not intended for children under four years of age with diabetes.
Sales of non-branded blood pressure monitors grew sixfold over the year
RNC Pharma reported that the Russian retail market for blood pressure monitors exceeded RUB 7.62 billion from January to August. In total, 3.85 million units were sold during this time. At the same time, sales of “no-name” devices on the Russian retail market increased sixfold over the year.
Other
GE Healthcare localizes production of medical equipment in Kazakhstan
A framework agreement on cooperation was signed during the visit of the President of Kazakhstan Kassym-Jomart Tokayev. The project involves localizing high-tech medical equipment throughout the country, modernizing infrastructure through the creation of a centralized national archive of clinical images, as well as expanding service capabilities.
The volume of investments that Kazakhstan plans to attract during the implementation of the project is estimated at $60 million. The range of equipment is not disclosed, but GE previously explored the possibility of localizing ultrasound and computed tomographs.
Source: https://t.me/vademecum_live/11469
New registered medical devices
We publish a list of new medical devices registered from 15.09.2023 to 21.09.2023
https://cont.asiamc.ru/uploads/blogs/2023-09-27/6513efd609f5f.pdf
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