News Digest 05.08.2024 — 07.08.2024
Regulators
Disposal of medical waste by class will be divided between three operators
The Federation Council approved amendments to the regulation of medical waste management. Changes are made to Federal Law No. 89-FZ of 24.06.1998 "On Production and Consumption Waste", Federal Law No. 323-FZ of 21.11.2011 "On the Fundamentals of Health Protection of Citizens in the Russian Federation" and Federal Law No. 52-FZ of 30.03.1999 "On the Sanitary and Epidemiological Welfare of the Population".
The amendments establish the identity of class "A" medical waste with solid municipal waste, and also define the features of disinfection of classes "B", "C" and "G" (except for especially hazardous waste) before their transfer to the regional operator for the management of MSW. Federal operators will handle the disposal of other waste. Disinfection can be carried out by the organizations themselves or by third-party companies included in special regional registries. The requirements for such companies will be established by the government.
In addition, waste from medical device manufacturers will be exempted from special regulation.
The changes are expected to come into force on September 1, 2026.
Read about the new procedure for handling medical waste in the article “Svedine”
FDA Updates Guidelines for Combating Misinformation about Drugs and Medical Devices
The US Food and Drug Administration (FDA) has issued updated guidelines for pharmaceutical companies and medical device manufacturers to combat misinformation about their products on the Internet.
As the agency notes, not all information available online about medical products can be trusted. Because there is a potential for poor decisions to be made based on inaccurate data, which can have negative consequences for patients’ health, the FDA has released a draft guidance document titled “Fighting Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.” In the document, the US regulatory agency recommends that companies use “specially designed response communications solutions” to combat the spread of misinformation online. This allows a manufacturer to publish an official message, for example, in response to a social media post made by a celebrity, health care professional, or influencer that contains false, inaccurate, and/or misleading information about a particular FDA-registered product. At the same time, the regulator emphasized that it will not impose any requirements on companies for their response publications.
Companies are allowed to combat misinformation only through online channels, including through online advertising materials. However, the FDA guidance does not apply to television and radio broadcasting. The new document replaced the regulator's previous draft guidance on this issue from 2014, known as "Web platforms and social networks: correcting inaccurate information from third-party sources about prescription drugs and medical devices." It addressed the issue of pharmaceutical companies and medical device manufacturers correcting incorrect information about their products on the Internet. However, over the past 10 years, it has not been approved.
Market news
Six projects will receive grants of up to 7 million rubles for the development of medical rehabilitation
The Skolkovo Innovation Center has summed up the results of the "Innovations in Rehabilitation" accelerator, during which new technological solutions for the restoration and improvement of the quality of life of people with disabilities were selected. During the voting, industry experts identified six winning projects that will be able to apply for a special grant for graduates of corporate acceleration programs to refine the product, protect intellectual property, and test developments. The grant amount can reach 7 million rubles.
According to Skolkovo, more than 450 proposals from manufacturers and developers of rehabilitation and habilitation products were submitted to participate in the accelerator. During the competition, more than 50 cooperation agreements, agreements of intent, and memorandums of understanding were signed, five supply agreements were concluded, and three sales were made.
The winners of the accelerator were the Brainstart, HyperCortex, Parkinson's Expert System, Walking School on Prostheses, Osteo-Cyber, and the ComboSpas hemostatic.
The Brainstart project was founded in 2022 to develop software that allows you to instantly track changes in brain activity to manage its activities. The iNeurofeedback neurointerface was developed by scientists from the HSE Center for Bioelectric Interfaces, the AIRI Research Institute of Artificial Intelligence, and the FMBA Center for Brain and Neurotechnology. The technology is planned to be used in post-stroke and sports rehabilitation, correction of age-related cognitive disorders and in the process of assistance with other pathologies.
The hardware and software complex "HyperCortex" is being developed by the company "Neurosputnik". The technology offers a method of neurorehabilitation in the form of a game for patients who have suffered a stroke and head injury. The program requires a non-invasive neural interface, a mobile application and a connection to a server with AI.
The developer of Parkinson's Expert System is "Intelligent Medical Technologies". The program will be used to diagnose neurodegenerative diseases, support medical decisions and predict the development of the patient's disease.
"ComboSpas" is a hemostatic based on 3D-structured sodium hyaluronate with increased reactivity, created by a team of scientists from Ryazan. The drug, according to the developers, is able to stop bleeding in 15 seconds. The authors expect to introduce the hemostatic into practical surgery for operations on the liver or brain.
The company "School of Walking on Prostheses" is developing an information complex that should help patients with lower limb amputation to restore walking skills close to natural, at home.
"Osteo-Siber" is a completely degradable magnesium implant. According to Skolkovo, there are currently no analogues of the product being developed in the world. The implant can be used in the bone healing process and does not require further extraction, which, according to the developers, will reduce the patient's hospitalization time.
The Skolkovo Foundation's "Innovations in Rehabilitation" program was initiated in June 2024. The innovation center reported that during the accelerator, participating projects will be able to receive an expert assessment, conclude contracts for the purchase of products and attract investment.
In early August 2024, the Russian government introduced a bill to the State Duma to amend the federal law regulating the work of Skolkovo. If the amendments are adopted, the powers to manage various types of activities of the innovation center, including medical ones, will be transferred from the federal level to the Moscow mayor's office.
Other
X-ray operating rooms are equipped in the capital's clinics and orthopedic robots are working
Two X-ray operating rooms have opened after renovation in the City Clinical Hospital No. 1 named after N.I. Pirogov. Due to this, the capabilities of high-tech X-ray surgical and hybrid interventions have expanded.
In City Clinical Hospital No. 31 named after Academician G.M. Savelyeva, they began to perform knee joint endoprosthetics using a high-tech orthopedic robot. It creates 3D reconstructions of joint surgeries. Developing a plan and the surgical intervention itself take about an hour. Thanks to this method, the patient's recovery is faster.
Russian bracelet to stop bleeding received a registration certificate
The Russian company Newman Technologies, which developed a bracelet to stop bleeding from the radial artery, received a registration certificate for the product. This was reported to TASS by the project leader, candidate of medical sciences Dmitry Ognerubov, at the project and educational intensive "Arkhipelago" held on Sakhalin.
"We received a registration certificate for our medical product, which is a critical achievement for us. <...> We are currently conducting a pilot study at the City Clinical Hospital No. 1 named after N.I. Pirogov, these works are two-thirds complete," Ognerubov said.
The device is a polyurethane bracelet with Velcro and air cushions, which is fixed on the wrist. It helps stop bleeding from the radial artery after cardiac surgery. Unlike foreign analogues, the development does not require checking every hour until the bracelet is removed. The study showed that the development reduces the incidence of blood clots by five times - up to 2.6% of cases, he said.
The project is participating in the in-person stage of the accelerator of the National Technology Initiative "Startup Hub", which is held from July 10 to 20 as part of the "Archipelago" intensive course.
"Archipelago" is an annual project-based educational intensive course for representatives of technology companies and startups, engineering teams, management teams of regions and universities, representatives of scientific organizations that develop projects in the field of new technologies. In 2024, the intensive course is held from July 8 to 21 in the Sakhalin Region. The main venues for the event are Yuzhno-Sakhalinsk and the Pushisty airfield. One of the key areas of the forum is the development of scenarios for the use of drones to build long-term plans for the development of the unmanned aviation industry in Russia.
The organizers of the intensive course are the National Technology Initiative (NTI) Platform, the Government of the Sakhalin Region, the Agency for Strategic Initiatives, NTI Project Support Fund and NTI University 2035.
Source: https://tass.ru/obschestvo/21370491
An express test for examining the oral cavity has been created in Novosibirsk
The Medical and Biological Union (MBS), a resident of the Novosibirsk Akademgorodok technopark, has developed an express test for detecting inflammatory processes in the oral cavity that has no analogues in the world. This was reported to TASS by Mikhail Losev, director of the MBS.
The difficulty in determining inflammatory processes in the oral cavity is due to the fact that the patient goes to a medical institution when the inflammatory process has already started and has led to consequences in the form of destruction of tooth enamel. One of the tests for the oral microbiota is a method based on chromatography-mass spectrometry. For the analysis, a scraping of biomaterial from the oral cavity is performed. The patient can receive the results of such a test only after five days.
"We have now developed a test for one of the major companies to detect inflammatory processes in the oral cavity so that a person can monitor this independently. The development is at the stage of implementation in production. We are developing something that has a low level of competition and high added value due to a high intellectual contribution," the agency's interlocutor said. As Losev explained, the development has no Russian or foreign analogues. According to him, it is based on the definition of inflammation by eight markers, including, in particular, the level of lymphocytes - cells of the immune system. The production of antibodies in the human body depends on lymphocytes. One of the common diseases of the oral cavity, stomatitis, is characterized by a high production of lymphocytes, with the help of which the immune system reacts to irritants. "There are inflammatory processes that are determined by the amount of lymphocytes. It is necessary to carefully monitor the hygiene of the oral cavity and mouth and control, since the inflammatory process can be a consequence of caries, for example," he said, adding that testing takes about 10 minutes. "Medico-Biological Union" is one of the largest Russian manufacturers of reagent kits for ELISA diagnostics of human infectious diseases, as well as a manufacturer of reference materials for quality control of diagnostic studies. The company became a resident of the Novosibirsk Akademgorodok (Akadempark) technopark, considered one of the most successful in Russia, in 2009. Akadempark is a comprehensive scientific and technological park with a unique innovation and business infrastructure. Thanks to the developed ecosystem, Akadempark employs teams of professionals who develop high-tech companies. More than 300 companies have already become its residents.
Sechenov University developed the Nette-MG needle for safe access to the abdominal cavity
Scientists from Sechenov University have developed an innovative Nette-MG needle for safe access to the abdominal cavity before laparoscopic surgeries. This new tool is planned to be introduced into practice after the completion of clinical trials and registration as a medical device, which is expected in 2025.
The main advantage of the Nette-MG needle compared to the traditional Veress needle is its improved accuracy in determining the moment of penetration into the abdominal cavity. The Veress needle can make it difficult for the surgeon to accurately determine this moment due to the lack of clear indicators. When in doubt, doctors resort to drip tests or gas insufflation, which can be inconvenient and not always reliable.
The new Nette-MG needle eliminates the need for additional procedures and expensive modifications equipped with sensors. It significantly simplifies the process and reduces the risk of damage to internal organs.
Preclinical studies are currently being conducted on laboratory animals. After completing all the necessary procedures, including the publication of the experimental results in a scientific journal, the Nette-MG needle will be ready for clinical use.
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