News Digest 31.07.2024 — 02.08.2024
Regulators
The government has approved a list of key areas of comprehensive rehabilitation
The government has outlined the key areas of comprehensive rehabilitation and habilitation of disabled people, for which standards for the provision of such services will subsequently be developed. Resolution No. 1033 of July 31, 2024, was published on the Cabinet of Ministers website.
We are talking about five areas - prosthetic and orthopedic care, vocational rehabilitation, including vocational guidance for disabled people and disabled children, social rehabilitation, as well as physical rehabilitation, which involves the use of adaptive physical education and adaptive sports. Another area of standards development is early assistance to children and their families.
The Ministry of Health and the Ministry of Labor will be involved in creating standards in various areas, in particular. For example, the departments will work together in the area of prosthetic and orthopedic care. They will have to develop separate procedures for disabled people who need prostheses, orthoses or hearing prostheses.
Research organizations involved in the rehabilitation and habilitation of disabled people should be involved in the creation of standards. The finished projects will be discussed with the participation of developers, public associations of disabled people, and public organizations.
In early July, the government approved the requirements for rehabilitation organizations. The government noted that their adoption is aimed at "improving the quality and accessibility of services for people with disabilities, as well as the level of socialization and quality of life of such citizens." The requirements approved by the resolution will come into force on March 1, 2025 and will apply to all types of organizations providing services in the areas of comprehensive rehabilitation and habilitation.
Putin instructed to prepare proposals on measures to support domestic manufacturers
Russian President Vladimir Putin approved a number of instructions following a meeting of the Council on Science and Education, as well as a meeting with recipients of mega-grants and leading scientists. Thus, the Government of the Russian Federation, together with the Russian Foundation for Technological Development (RFDT), must prepare and submit proposals on measures to support domestic manufacturers implementing the results of scientific research and development in industrial production. The implementation deadline is November 1, 2024.
In addition, the government must ensure the development and implementation of a unified program for mega-grants on the basis of the Russian Science Foundation (RSF). To this end, it is necessary to provide annual subsidies from the federal budget starting in 2025. It is also necessary to submit proposals to determine the mechanisms for attracting private investment to implement the mega-grant program. The deadline for completing the instruction is October 1, 2024.
Together with the Presidential Administration of the Russian Federation, the RSF and regional authorities, the Government of the Russian Federation must develop and implement measures to attract leading researchers and specialists (including foreign ones) to participate in scientific research and development, providing for the creation of favorable conditions for them and their family members (provision of housing, simplification of the paperwork (including electronic visas) required for entry and work in the Russian Federation). The report must be submitted by October 1, 2024, and then annually.
The report on the development of a financial model for the maintenance and efficient use of laboratories created to implement measures to attract leading scientists and young researchers, where the implementation of relevant projects has been successfully completed, must be submitted by the Government of the Russian Federation jointly with the Administration of the President of the Russian Federation by December 1, 2024.
The government must also provide for the formation of individual federal projects by September 1, 2024 for the development of the most important science-intensive technologies and for the advanced training and retraining of qualified personnel in the relevant areas, including target indicators in these projects, and also ensure the inclusion in the national project "Youth and Children" of activities aimed at improving the quality of teaching mathematics, physics, chemistry and biology in schools and colleges. In addition, it is necessary to provide for the coordination of national projects in terms of personnel and scientific support for their implementation with the Commission for Scientific and Technological Development of the Russian Federation.
The mega-grant program was launched in 2010. In September 2023, Vladimir Putin ordered an increase in the maximum size of government mega-grants for state support of scientific research from 90 million rubles to 500 million. Support for foreign specialists is also provided - up to 250 million rubles are planned to be allocated for their developments. The research period has also been increased - from three to five years with the possibility of extension. In May 2024, the Ministry of Education and Science of Russia distributed subsidies to educational and scientific organizations to attract young scientists to participate in research, as well as to implement projects under the supervision of leading scientists. The list of competition winners includes four projects on medical topics. A total of 2 billion rubles will be allocated from the federal budget for their support from 2024 to 2028.
Market news
The government will additionally finance the purchase of equipment for neonatal screening
More than 346.3 million rubles will be additionally allocated from the federal budget for the purchase of equipment for expanded neonatal screening of newborns. The order was published on the government website on August 2.
The procurement plan includes tandem mass spectrometry devices with a nitrogen generator and software for neonatal screening, automatic stations for digging PCR mixtures and equipment for ultrasound DNA fragmentation. It will be received by federal and regional medical organizations.
The program of expanded neonatal screening for 36 rare and hereditary diseases was launched in Russia on January 1, 2023. Previously, children were tested for five diseases. The project is supervised by 11 federal and regional medical organizations responsible for these studies, each of which is assigned certain regions.
According to the results of examinations in 2023, more than 22 thousand children out of 1.23 million examined were at risk. It is assumed that such studies help to identify serious diseases at an early stage, and provide assistance to children faster. It was reported that this will save up to 1 thousand children's lives annually, MV wrote.
Other
An artificial intelligence-based model has made it possible to predict infertility in men
Scientists from Toho University in Japan have developed a predictive model based on artificial intelligence that can predict infertility in men before conducting a spermogram. The results of the study are published on the EurekAlert website.
To make a prediction, the model uses data on the blood levels of five hormones associated with the formation of seminal fluid: luteinizing hormone, follicle-stimulating hormone, prolactin, testosterone, and estradiol. The ratio of testosterone to estradiol is also assessed. The accuracy of the model in detecting male infertility was 74%, and in diagnosing the most severe form of infertility, non-obstructive azoospermia, it was 100%.
Texas Heart Institute Implants Total Artificial Heart
Texas Heart Institute (THI) and BiVACOR®, a clinical-stage medical device company, today announced the successful first human implantation of a BiVACOR total artificial heart (TAH) as part of a U.S. Food and Drug Administration (FDA) preliminary feasibility study (EFS) on July 9, 2024. BiVACOR's TAH is a single-moving-part, titanium biventricular rotary blood pump that utilizes a magnetically levitated rotor to pump blood and replace both ventricles of the heart in cases of heart failure. The aim of the first clinical trial in humans is to evaluate the safety and efficacy of BiVACOR TAH as a bridge-to-transplant solution for patients with severe biventricular heart failure or single-ventricular heart failure for whom left ventricular support is not recommended. Following this first implantation, completed at Baylor St. Luke's Medical Center in the Texas Medical Center, four more patients will be enrolled in the study.
Source: https://www.texasheart.org/the-texas-heart-institute-implants-bivacor-total-artificial-heart/
A robot has been created that replaces a dentist
According to Alexander Gorny's Telegram channel, the American company Perceptive has demonstrated a robot dentist with artificial intelligence (AI), capable of performing manipulations with a patient 8 times faster than a human doctor. For example, the robot spends 15 minutes on placing a filling.
The robot has not yet been approved by the American regulator, and Perceptive has not specified a time frame for its implementation. So dentists can sleep peacefully for now!
Source: https://t.me/medicalksu/5148
Newly registered medical products
We publish a list of new medical products registered from 26.07.2024 to 02.08.2024
Link to the list: [see table in the attachment]
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