News Digest 18.09.2024 — 20.09.2024
Regulators
Medicine provision in the Belgorod, Kursk and Bryansk regions will be carried out in a special manner
The government has approved the specifics of preferential provision of medicines, medical devices and therapeutic nutrition products for disabled children from 2024 to 2025. We are talking about residents of the Belgorod, Kursk and Bryansk regions who were forced to leave their homes. The corresponding resolution No. 1276 of September 18, 2024 was published on the legal information portal.
According to the document, preferential medicine provision is to be financed from the federal budget. The government instructed the Ministry of Health to approve the application form for the transfer of inter-budget transfers from the federal budget to the budgets of the constituent entities of Russia to compensate for expenses within 30 days. Regions must submit such an application twice a year no later than June 15 and November 15 of the current year.
Market news
A case was opened in Khabarovsk on a cartel worth 373 million rubles in the supply of medical devices
The Office of the Federal Antimonopoly Service (UFAS) for Khabarovsk Krai discovered a cartel agreement and opened a case against seven companies that, as the regulator assumes, supplied medical devices at inflated prices to clinics in the region and the entire Far Eastern Federal District. The total value of 648 contracts is 373.5 million rubles.
According to the Federal Antimonopoly Service, the anticompetitive agreement was concluded by Spektr-DV LLC, Vector-Best-Amur JSC, Medias LLC, ALEF LLC, VostokMedBusiness LLC, Dalmedical Company LLC, and Medtekhnika-Service LLC. If found guilty, the organizations face turnover fines.
According to SPARK-Interfax, all companies are registered in Khabarovsk. The main activities of the legal entities are wholesale trade in pharmaceuticals and medical devices, repair of electronic and optical equipment.
The owner of Spektr-DV LLC is Valeria Dunayevskaya. The company's revenue for 2023 amounted to 739.3 million rubles, net profit - 86.9 million rubles. Vector-Best-Amur is 90% owned by Vector-Best JSC and 10% by three Russian citizens. The legal entity's revenue for 2023 reached 337.6 million rubles, net profit - 12.9 million rubles.
OOO Medias is owned by Oleg Karpov. The company's revenue for 2023 amounted to 331.3 million rubles, net profit - 15.4 million rubles. The owners of OOO Alef are Sergey Folyushnyak (98%) and Bogdan Sarancha (2%). In 2023, the company earned 128.03 million rubles with a net profit of 14.3 million rubles.
OOO VostokMedBusiness is owned by Elena Strukova (66.6%) and Elena Knyazkina (33.4%). The company's revenue for 2023 amounted to 81.8 million rubles, net profit - 1.3 million rubles. In addition, Elena Knyazkina owns Dalmedical Company LLC, whose revenue for 2023 was 47.7 million rubles, net profit - 1.04 million rubles. Elena Strukova owns Medtekhnika-Service LLC, where Knyazkina is the CEO. The company's revenue for 2023 was 31.4 million rubles, loss - 5.03 million rubles.
The Khabarovsk UFAS suspected a cartel agreement in June 2024. At that time, it was reported that the cartel was identified based on the results of inspections of more than 600 purchases for a total of over 300 million rubles.
Other
Neuralink implant for vision restoration received the status of a technological breakthrough in the USA
The US Food and Drug Administration (FDA) has assigned the status of "technological breakthrough" to the Blindsight device from the American company Neuralink, founded by Elon Musk. The technology is an implant that, according to the developers, will allow patients to restore vision even in the absence of both eyes and the optic nerve.
Musk announced the start of the development of the implant on social networks in March 2024. Then the entrepreneur emphasized that the device had already been tested on monkeys.
At the moment, Neuralink does not provide details about the device. According to the Reuters news agency, Blindsight is equipped with a chip that processes and transmits neural signals, which can also be output via a computer or phone. The developers could not give an exact answer about the planned period for the start of human trials. The FDA has been assigning the “breakthrough technology” status to medical devices since 2017. It is issued before permission for the mass introduction of technologies that can provide more effective treatment or diagnosis of life-threatening diseases or disorders. Developers of devices with such status are entitled to consult with the FDA on the implementation of the project, the regulator considers such technologies on priority applications, in addition, the approval process for devices with such status can take place through a simplified 510(k) procedure, and permission for its sale can be characterized as De Novo, that is, permission for the first of its kind e product.
To obtain the “technological breakthrough” status for their device, developers need to prove to the regulator that the device meets at least one of four requirements: the medical device is a “breakthrough” technology; there are no approved alternatives on the market; the device offers significant advantages over existing approved alternatives; the availability of the medical device is in the interests of patients.
Neuralink was founded by Elon Musk and a group of engineers in 2016. The company, among other things, is developing a brain implant that will allow people who “have lost control of their limbs” to interact with a computer using the power of thought. The neurochip was first implanted into a human brain in January 2024. In August of the same year, Elon Musk announced the successful implantation of the device into the brain of a second patient. The entrepreneur stated that in the next 10 years, the company plans to increase the number of implant users to several million.
Newly registered medical devices
We publish a list of new medical devices registered from 09.13.2024 to 09.20.2024
Link to the list: [see table in the attachment]
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