News Digest 22.05.2024 — 24.05.2024
Regulators
FAS plans to automatically detect cartels in government procurement
The Federal Antimonopoly Service (FAS) has published a bill on the creation of a state information system (GIS) to prevent, identify and suppress competition-restricting “Anti-Cartel” agreements. GIS will conduct a comprehensive data study and daily analysis of 100% of ongoing procurement procedures under 44-FZ and 223-FZ, as well as property auctions.
“When investigating cartels, the FAS Russia previously used an automated information system in pilot mode. GIS "Anti-Cartel" with the help of elements of artificial intelligence involves the introduction of new, broader functionality. It includes automated analysis of trading on a daily basis and a risk-based approach, as well as integration with other information systems and databases of authorities and companies,” the FAS press service said.
The creation of the system will ensure significant savings in budgetary funds through the decartelization of state and municipal procurement and the creation of competitive conditions for bidders.
Market news
MED-XML: obtaining an electronic registration dossier for a medical device according to the EAEU standard in 1 minute
The St. Petersburg company Medpartner has developed software that will allow participants in the medical device market to receive an electronic dossier in XML format in 1 minute that meets the requirements of the EEC Board Decision No. 78 of June 30, 2017. “We were the first in Russia to come up with a comprehensive automated solution for government agencies, government services, and legal entities,” said the company’s general director, Irina Zolotova. A free trial version of the product will be available to users at the end of May. A link to the resource will be published additionally.
“In the course of mastering the processes of registration of medical devices according to the rules of the EAEU, many manufacturers and suppliers are faced with the problem of submitting a registration dossier in XML format, which must comply with the “Requirements for the electronic form of applications and documents of the registration dossier submitted during registration and examination of safety, quality and effectiveness medical devices”, approved by the Decision of the EEC Board of June 30, 2017 No. 78. Our team also encountered this problem when first submitting a dossier for registration of a medical device in Kazakhstan as a reference state. It turned out that there are no programs, all that is offered on the market is “manual” translation of documentation into XML format, which means a waste of time, that is, the most expensive resource, as well as the likelihood of inaccuracies and errors,” says Irina Zolotova. “And then we independently developed the software - an automated system, which currently has 4 operation options.”
What is the MED-XML solution
The MED-XML solution set is designed to automate the creation of a registration dossier according to the EAEU standard in XML format. Implements the tasks set by regulators and simplifies the exchange and processing of dossiers between member countries of the EAEU.
The complex includes:
- Cloud service for creating dossiers in XML format according to the EAEU standard.
- Corporate service CORP-XML – a solution installed on company servers for use in a closed loop.
- Integration solution for government services GOV-XML – a service that connects to the portal and provides operators with access to tools for generating XML according to EAEU standards when submitting registration dossiers electronically through “Government Services”.
- DESC-XML software is a solution for inspection authorities that allows you to validate and convert a document from XML format into a folder with PDF documents.
Innovation of the MED-XML solution
Medpartner has developed software and a service that takes care of generating XML templates, validating and checking XML formats, providing end users with a convenient form for filling out data and uploading documents to create a dossier. The final document is generated using unique software. XML can be downloaded and immediately sent to regulatory authorities.
Pros of using the solution:
- Convenient and simple service for generating complex documents.
- The software takes care of preparing the correct format, and if there is a need to change the rules or the resulting XML document, it quickly makes changes to the template.
- To use the service, registration on the portal is sufficient.
- For private companies and organizations that want to store data on their servers, the solution can be deployed in a corporate environment.
- Inspection authorities are provided with a comprehensive solution for document validation and storage.
Advantages of switching to the EAEU standard
The transition to the XML format for registration dossiers in connection with the requirements of the EAEU provides several key advantages. Here are some of them:
- Standardization and unification of data. The XML format provides a unified standard for data presentation, which greatly simplifies their exchange and processing between member countries of the EAEU. This helps standardize registration processes and ensures better data interoperability.
- Improved accessibility and readability. Data in XML format is easy to read by both humans and machines, making it easier to analyze and process. This also makes it easier to verify and confirm the information in the dossier.
- Automation of data processing. Using XML allows you to automate many data processing processes, which reduces the likelihood of errors and speeds up the registration process. Automation also makes it easier to make changes and updates to the file.
- Better multi-language support. The XML format supports the use of various languages, which is extremely important for a multilingual region such as the EAEU. This facilitates the exchange and understanding of documentation between countries with different language groups.
- High data security. The XML structure allows for greater control over data access and security. You can easily configure different levels of access to the information in the dossier, thereby ensuring its confidentiality.
- Improved integration with other systems. Dunn Data in XML format are easily integrated with various information systems used in the EAEU countries, which contributes to more effective interaction and data exchange between regulatory and supervisory authorities.
- Saving time and resources. Unification of the documentation format and automation of processes significantly reduces the time and resources required for the preparation and processing of registration dossiers, which has a positive effect on the speed of bringing products to market.
“The transition to the XML format within the framework of the EAEU requirements creates the basis for more effective and harmonized regulation in the field of circulation of medical devices and other categories of products in the EAEU member countries, thereby promoting their closer economic and technical cooperation. Currently, our software product is at the stage of being included in the register of domestic software,” sums up Irina Zolotova.
“Circle of Good” spent 120 billion rubles in 2023. to provide assistance to wards
The Circle of Good Foundation presented a report on the results of its activities in 2023. The organization received 145.5 billion rubles, and spent 120.9 billion rubles on the purchase of 113 types of medicines, technical means of rehabilitation, medical products, payment for 9 types of high-tech innovative medical care. At the same time, it was possible to save 12.5 billion rubles on the purchase of drugs not registered in Russia.
“The Fund independently purchases unregistered medicines. Thanks to direct negotiations with manufacturers, we were able to achieve savings of RUB 12.5 billion. on the purchase of medicines,” said the chairman of the board of the fund, Alexander Tkachenko, during a press conference, reports the “FV” correspondent.
In 2023, the fund allocated 50.1 billion rubles for the purchase of registered drugs, 21 billion rubles for the provision of children under the VZN program, and 49.2 billion rubles for unregistered drugs. Financing for the supply of medical devices, including unregistered ones, amounted to RUB 339.2 million. In 2022, more than 40 billion rubles. spent on the purchase of registered drugs and 20.6 billion rubles. – for unregistered drugs.
In total, from the start of the fund’s work in 2021 until the end of 2023, the fund spent 212 billion rubles on the purchase of medicines and other treatments. During this time, 23,580 children received treatment.
“As of May, 25 thousand children with 97 different diseases are already receiving help from us. To date, the fund has spent 239 billion rubles. for the purchase of drugs. We plan to further expand the list of purchased medicines,” Tkachenko said.
According to the fund’s report, the balance of the grant as of April 1, 2024 amounted to 46.9 billion rubles. At the end of 2022, the balance was 131.3 billion rubles. Then the fund explained that the financing scheme is designed to ensure that the fund can guarantee the fulfillment of obligations already taken to families with sick children.
Other
The advantages of robot-assisted cholecystectomy are named
Scientists from Emory University in Atlanta compared the effectiveness and safety of robot-assisted cholecystectomy with laparoscopic gallbladder removal. The results of the study were published on Medpage Today.
The analysis found that about 3.7% of patients who underwent laparoscopy for gallbladder surgery experienced complications leading to permanent disability, organ resection, or death, compared with 2.6% of patients who underwent similar minimally invasive robotic-assisted surgery. technology. The rate of conversion to laparotomy was 2% for the laparoscopic approach and 0.8% for the robotic surgery group.
A hospital stay of more than 24 hours was observed in 48.2% of laparoscopy patients compared with 32.7% of robotic surgery patients. The incidence of death did not differ between the two treatments: it occurred during or after the procedure in 0.2% of patients undergoing laparoscopy and in 0.1% of patients undergoing robotic surgery.
The authors concluded that robotic surgery may make gallbladder surgery a safer procedure. However, more data are needed on the long-term safety of robotic cholecystectomy.
Source: https://medvestnik.ru/content/news/Nazvany-preimushestva-robot-assistirovannoi-holecistektomii.html
Anesthesiologists and resuscitators will be offered a hardware and software ecosystem
At the Samara State Medical University (SamSMU), a unified hardware and software ecosystem of anesthesiology and resuscitation services is being created. Its circuit will include a central monitoring station, anesthesia and respiratory equipment, monitors of the patient’s vital functions, infusion stations and pumps in the operating unit, the department of anesthesiology, resuscitation and intensive care, the press service of the university reported.
According to the developers, an integrated approach will provide a holistic view of the patient’s condition and will help in making medical decisions. The software “Automated workstation of an anesthesiologist-resuscitator” developed at SamSMU consists of several modules: “Anesthesia card”, “Anesthesia protocol”, “Patient indicators”, “Interface of MIS anesthesiologist-resuscitator”. The development has already received a certificate of state registration of intellectual property.
The project provides for the integration of all equipment with digital content available in intensive care and anesthesiology: anesthesia-respiratory machines, artificial lung ventilation devices (ventilators), modern infusion pumps and other equipment that contains information about the patient and can record, store and process it. Some equipment was additionally purchased for SamSMU clinics, which also became an important link in the digital ecosystem.
FDA recognizes 'breakthrough' test for cardiovascular disease susceptibility
The US Food and Drug Administration (FDA) has granted breakthrough device status to Roche's Tina-quant test. This is stated in a press release from the Swiss manufacturer.
The test is designed to determine lipoprotein(a) (Lp(a)) levels from a blood sample. It plays an important role in transporting lipids in the body. High Lp(a) levels may indicate a genetic predisposition to cardiovascular diseases such as atherosclerosis, myocardial infarction and stroke
The purpose of Tina-quant is to help prevent the development of heart disease in the early stages. According to the company, there are currently no FDA-approved tests for Lp(a) levels.
According to Roche, elevated Lp(a) levels affect one in five people worldwide. However, lifestyle changes do not have a significant effect on its concentration in the blood. Elevated Lp(a) can be associated with non-genetic factors, but in more than 90% of cases, high levels are caused by mutations in the LPA gene.
“Breakthrough” devices are those that have demonstrated the ability to more effectively treat or diagnose serious diseases. Medical devices that receive this designation are reviewed by the FDA on an expedited basis. This makes it possible to quickly introduce innovative technology into clinical practice.
Head transplant: AI concept
Neuroscience and biomedical engineering startup BrainBridge has presented a concept for a head transplant system. According to the author, the operation will be performed by a robot with AI, which will minimize the human factor. In addition to head transplantation, the robot will be able to perform plastic surgery - face and scalp transplantation. According to the website, the company will conduct the first procedure within ten years. The project is promoted by German-based molecular biologist, blogger and screenwriter Hashem Al-Ghaili.
Video: https://www.youtube.com/watch?v=3_ZlCD2RYc8
In November 2017, Italian surgeon Sergio Canavero announced that in China, together with a team from Harbin Medical University, he had performed the “world’s first” human head-to-cadaver transplant. The transplant operation lasted 18 hours and resulted in connecting the spine, nerves and blood vessels. It was not possible to verify how successful it was.
Source: https://t.me/delotom/411
New registered medical devices
We are publishing a list of new medical devices registered from 05/17/2024 to 05/24/2024
Link to the list: [see. table in attachment]
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