News Digest 17.07.2024 — 19.07.2024
Regulators
The procedure for confirming the intended purpose of imported equipment for the medical industry has been updated
The Ministry of Industry and Trade approved Order No. 1243 dated March 27, 2024 on the organization of work in the Ministry to confirm the intended purpose of imported equipment for the medical industry.
The Department for the Development of the Pharmaceutical and Medical Industry was instructed to review the following documents from the applicant within 20 working days from the date of receipt by the Ministry:
- an application for the issuance of a conclusion on confirming the intended purpose of equipment for the medical industry;
- copies of contracts providing for the import and intended purpose of the declared goods to the territory of Russia;
- copies of contracts with an intermediary;
- information on the technical characteristics of the goods;
- technical descriptions, product passport;
- information on the estimated dates for putting the goods into operation.
Within five working days after the end of the review of the documents, the Ministry of Industry and Trade must prepare a draft letter confirming the intended purpose of the goods or on the impossibility of the intended purpose. Within five working days after the day of signing such a letter, the authorized Deputy Minister of Industry and Trade ensures that the document is sent to the applicant.
Deputy Minister of Trade and Industry Ekaterina Priezzheva is responsible for monitoring the execution of the order.
According to the document, the previous order of the Ministry of Industry and Trade No. 3766 of September 24, 2018 "On the organization of work in the Ministry of Industry and Trade of the Russian Federation to confirm the intended purpose of imported equipment for the medical industry" is no longer in effect.
Market news
A prosthetics center for the military has opened in Belgorod
The first regional Center for high-tech prosthetics and comprehensive rehabilitation in Russia has opened in Belgorod. At the beginning of this year, the "Defenders of the Fatherland" foundation, the government of the Belgorod region and JSC "CITO" signed an agreement on its creation. And in the shortest possible time it was prepared, equipped with the most modern equipment, provided with highly qualified specialists," the deputy minister said.
The institution is designed to receive 500 people per year. These are both veterans from Belgorod and residents of other regions.
So, according to the deputy minister, the opening of similar centers in St. Petersburg, Leningrad and Omsk regions is in line.
She noted that the center is a branch of JSC "CITO" - one of the leading developers and manufacturers of technical rehabilitation equipment. "There they will not only make prostheses for our heroes, but also provide them with comprehensive rehabilitation. For this purpose, even systems with artificial intelligence have been installed," Tsivileva added.
Source: https://ria.ru/20240717/tsentr-1960290743.html
A department of radionuclide diagnostics has opened at the Lopatkin Research Institute
A department of radionuclide diagnostics has opened at the N.A. Lopatkin Research Institute of Urology and Interventional Radiology, a branch of the NMIC of Radiology, the Center's press service reported on July 17. The project was implemented within the framework of the federal project "Fight against cancer", the amount of investment is not disclosed.
The new department is equipped with expert-class equipment, in particular, a GE Discovery IQ 5r PET/CT scanner with highly sensitive detectors and a wide field of view, as well as a Siemens Evo Excel two-detector gamma camera.
At the N.A. Lopatkin Research Institute of Urology and Interventional Radiology, a branch of the NMIC radiology opened a department of radionuclide diagnostics, the press service of the Center reported on July 17. The project was implemented within the framework of the federal project "Fight against oncological diseases", the amount of investment is not disclosed.
The new department is equipped with expert-class equipment, in particular, a GE Discovery IQ 5r PET / CT scanner with highly sensitive detectors and a wide field of view, as well as a Siemens Evo Excel two-detector gamma camera.
Other
The Moscow Department of Health assessed the prospects of computer vision services
The Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Department of Health (DZM) presented a "maturity matrix" of computer vision services used to analyze medical images. Experts assessed the prospects of artificial intelligence (AI) based on its performance indicators for the first quarter of 2024. The development of such technologies is carried out during the experiment of the Department of Health, and service providers periodically receive grants from the Department of Health (their total amount has already exceeded 100 million rubles).
To evaluate AI, samples were compiled from 80 image studies, selected randomly with enrichment towards studies with pathology. Specialists from the Center for Diagnostics and Telemedicine assessed the stability of the programs, and also gave a clinical assessment of the services, derived from a comparison of AI decisions and the conclusions of radiologists.
In the direction in the "abdominal CT scan" category, experts singled out the integrated services developed by Medical Screening Systems and Third Opinion Platform. The Celsius AI from the first organization had no technical defects in 99.4% of cases and also demonstrated 93.5 units of compliance of its findings with the doctor's conclusions. The Third Opinion Platform demonstrated technical stability in 98.8% of analyses and the second indicator at 92.2 units. The Abdomen-IRA service from Ira Labs, which received the largest grants from the Department of Health of the Russian Federation for research conducted in November 2023 - January 2024 on the development of computer vision technologies, demonstrated technical stability in 98.1% of cases and received 85.9 units for compliance of the results with the doctor's conclusions. In the direction of "CT of the brain", the integrated service "Celsius" had no failures in 99% of studies and received 90.4 points for the accuracy of detecting pathologies. AI, developed by the company "Airim", which also received large grants from the Department of Health of the Ministry of Health, turned out to be more stable in technical terms (99.2% of cases without failures), but lagged behind the competitor in the indicator of coordinating its decisions with the conclusions of doctors, receiving 85.4 points. The greatest difficulties for computer vision services arise when analyzing medical images of the chest organs - X-rays and fluorographs. For AI studies in this direction, the Department of Health of the Ministry of Health sets the highest rates when issuing grants - up to 28.6 thousand rubles for one analysis. Services from Medical Screening Systems, ArtVision, and Third Opinion Platform demonstrate high technical stability (90.8-100%), but rarely coincide with the opinion of doctors in their conclusions - for this indicator, they receive from 58.8 to 75.5 units with an optimal indicator of >81 units.
In the direction of "head X-ray", the AI from Innopolis University was more successful than its competitors - this service for detecting sinusitis works stably in 92.1% of studies, for the ratio of results to the conclusion of doctors, it received 89.7 points.
The AI from Oxygen Technologies Rus copes better with X-ray diagnostics of diseases of the musculoskeletal system than other services. It received 96.9 points for the accuracy of detecting pathologies. In the study of mammograms, computer vision services, as well as in the analysis of chest X-rays and fluorography, cannot yet overcome the threshold of the optimal indicator of the ratio of their findings to the conclusion of doctors at 81 units.
In the direction of "magnetic resonance imaging", the highest indicators are demonstrated by the services of the company "Imvision", coping with the detection of protrusion, herniated discs, stenosis of the spinal canal, multiple sclerosis and intracranial neoplasms by 81-92.6 points.
The Center for Diagnostics and Telemedicine of the Department of Health of the City of Vademecum explained that the institution is organizing an experiment on the use of computer vision technologies for the analysis of medical images, which has been conducted for almost five years. "This is the world's largest prospective clinical study of the applicability and quality of AI technologies in radiation diagnostics," the center reported. For research conducted by private companies during the experiment for November 2023 – March 2024, the Department of Health of the Russian Federation paid more than 114.5 million rubles.
Source: https://vademec.ru/news/2024/07/19/dzm-otsenil-perspektivnost-servisov-kompyuternogo-zreniya/
Newly registered medical products
We publish a list of new medical products registered from 12.07.2024 to 19.07.2024
Link to the list: [see table in the attachment]
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