News Digest 19.06.2024 — 21.06.2024
Regulators
Guidelines for technical and clinical trials of medical devices with AI have been updated
Scientists from the Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Department of Health (SPCC D&T DZM) have supplemented the guidelines for conducting technical and clinical trials of medical software with artificial intelligence (AI) technologies. Accredited testing laboratories and licensed medical organizations in Russia can use the guidelines, the center's press service reported.
According to Ilya Tyrov, Deputy Head of the DZM, following these methods helps maintain a high level of quality control, efficiency, and safety of medical devices in healthcare. Before software becomes part of routine practice, it must undergo both technical and clinical trials to obtain state registration. The methods for conducting such tests play a decisive role in this process.
Market news
A multidisciplinary sanatorium will be built in Pyatigorsk for 3.7 billion rubles
A multidisciplinary sanatorium "Gorny Brilliant" will be built in Pyatigorsk (Stavropol Krai). Financing for the work on the site will be provided by borrowed funds in the amount of 3.7 billion rubles, provided under the preferential lending program of the bank "Dom.rf".
It is assumed that the four-star complex will include 252 rooms, as well as a SPA, medical offices, a swimming pool, a fitness room and a restaurant. They intend to build the sanatorium near the attractions of the region - the underground cave "Proval" and the gazebo "Aeolian harp".
Other
Almost half of doctors did not see a reduction in their workload as a result of the introduction of medical devices with AI
About half of the surveyed healthcare specialists who already use medical devices with artificial intelligence (MD with AI) in their work noted that this led to a decrease in their workload. The other half did not see such changes. These are the results of a survey conducted by the Central Research Institute of Healthcare Organization and Informatization (TsNIIOIZ) of the Ministry of Health of the Russian Federation from June 4 to 10, 2024. The data were presented on June 19 at the All-Russian Congress "ITM Petersburg" by Alexandra Bondarovich, a leading specialist in the strategic development department of healthcare at the Research Institute, the MV correspondent reports. The experts discussed the possible causes of the current situation and ways to eliminate them. Almost 60% of respondents stated a positive attitude towards the introduction of MI with AI. Only 5% gave a negative assessment. Just over 35% are neutral about this, Bondarovich said.
Less than half (44%) of respondents noted a reduction in the workload as a result of the introduction of MI with AI, but 55% noted an improvement in the quality of protocols that are formed based on the results of using such medical devices, according to the survey results.
Newly registered medical devices
We publish a list of new medical devices registered from 06/13/2024 to 06/21/2024
Link to the list: [see table in the attachment]
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