News Digest 06.05.2024 — 08.05.2024

Regulators

Public procurement will be made easier for medical organizations by reducing the number of professional complainants

Since 2024, the Federal Antimonopoly Service (FAS) has been considering complaints about public procurement only from participants. This measure will reduce the number of professional complainants receiving compensation for non-interference in the procurement process. Customers hope that the work of such companies will become more difficult, and the procedure for purchasing drugs and medical products will not be delayed, according to experts interviewed by the Medical Bulletin newspaper.

Source: https://medvestnik.ru/content/news/Medorganizaciyam-oblegchat-goszakupki-za-schet-umensheniya-chisla-professionalnyh-jalobshikov.html

The Government of the Russian Federation resigned

Until the appointment of a new composition, Deputy Prime Minister Tatyana Golikova and Health Minister Mikhail Murashko will remain in their posts as acting officials.

The issue should be resolved within two weeks. There are rumors in the information field that the post of Deputy Prime Minister will be taken by Anastasia Rakova (the current Deputy Mayor of Moscow). Telegram channels do not say who will replace Mikhail Murashko, but some are sure that he will not keep this post.

Source: https://t.me/delotom/401


Market news

A clinic will be built in the Kemerovo region for 1.25 billion rubles

The Ministry of Construction of the Kemerovo Region is looking for a contractor for the construction of a clinic at the Kiselevsk City Hospital. It is planned to allocate 1.246 billion rubles from the regional budget for the construction of a medical facility. The clinic will serve the adult and child population of the Krasny Kamen microdistrict in the city of Kiselevsk.

According to the UIS in the field of procurement, the contractor must complete all work under the contract by December 15, 2025. The distribution of funds is provided for three years: in 2024, the contracting organization will receive 380.2 million rubles, in 2025 – 466.36 million rubles, and in 2026 – 400 million rubles.

The clinic building will be located on a plot of 0.5 hectares in Western Passage. The medical institution has adult and children's departments, antenatal clinics, departments of dentistry, functional diagnostics, rehabilitation and physiotherapy, radiation diagnostics, as well as a point for dispensing baby food.

The adult department is designed for 250 visits per shift, the day hospital has 8 beds, and the isolation and diagnostic box has one bed. It is planned that 14,464 people will be assigned to the clinic. The children's department will be able to receive up to 65 visitors per shift, there will be a day hospital with 4 beds and an isolation and diagnostic box with one bed. The antenatal clinic and dental department are designed for 50 visits per shift.

In June 2023, the Ministry of Construction of the Kemerovo Region published two tenders - for the construction of a children's clinic for the Belovskaya City Hospital for 514.3 million rubles and a multidisciplinary clinic to serve adults and children in the town of Bachatsky for 732.2 million rubles. Contractors need to build both facilities by December 2024.

Source: https://vademec.ru/news/2024/05/07/v-kemerovskoy-oblasti-postroyat-polikliniku-za-1-25-mlrd-rubley/

Deputy general director of Krasnoyarsk Medtechnika was detained for illegal bonuses

In the Krasnoyarsk Territory, a criminal case has been initiated against the Deputy General Director of Medtekhnika JSC. He is accused of abuse of power out of personal interest, the press service of the regional department of the Investigative Committee reported.

The name of the person involved has not been released. According to the preliminary version of the investigation, in August 2023, he acted as the general director of the joint-stock company and, acting out of selfish interest, ordered the issuance of an order for his bonus based on the results of work for 2022 in the amount of about 440 thousand rubles. Also, this order imposed illegal payments to two more deputy general directors and the chief accountant, also in the amount of about 440 thousand rubles. to each.

The accused did not have the right to make such a decision and violated the procedure for considering the issue of payment of remuneration by the board of directors of the joint-stock company, the investigation believes. As a result, the organization suffered damage in a total amount of more than 1.7 million rubles.

The deputy general director was detained and charged. The issue of choosing a preventive measure will be considered in the near future.

Source: https://vademec.ru/news/2024/05/07/v-kemerovskoy-oblasti-postroyat-polikliniku-za-1-25-mlrd-rubley/

R-Pharm introduced the QuantumEye 789 computed tomograph to the Russian market

The R-Pharm company received a registration certificate for the QuantumEye 789 tomograph (available in the 256/512 slice version) on April 18, 2024. The device is manufactured by China's MinFound Medical Systems and will be supplied with the IntelliAtlas medical imaging workstation.

MinFound Medical System was founded in 2011, its main profile is equipment for X-ray computed tomography and positron emission tomography. In February 2017, MinFound Medical System, along with nine companies, led a collaboration to create China's first 256-slice CT scanner, receiving $7.35 million in support from the Chinese government.

In August 2019, MinFound Medical System announced its intention to localize the production of high-tech medical equipment - computer and positron emission tomographs - in the PharmMedPolis RT cluster. The total investment in the project was estimated at 1–3 billion rubles. And R-Pharm was previously involved in the distribution of Canon Medical System heavy medical equipment and even planned to localize the production of its products in Russia.

The Russian CT market is estimated at 20–30 billion rubles per year. Since the beginning of the 2020s, brands from Southeast Asia began to increase their presence in our market: in 2021 and 2022, the Chinese Anke introduced new multi-slice computed tomographs and a 1.5 Tesla magnetic resonance tomograph to the market. In 2022 and 2023, the Russian representative office of the Belarusian medical equipment manufacturer Adani registered in Russia a 32- and 128-slice Ventum computed tomograph, created on the basis of a localized version of the Chinese Insitum series tomographs from Sinovision Technologies.

In February 2024, the first line of medical products from the Chinese vendor United Imaging Healthcare (UIH) was registered on the Russian market. The applicant was the registrar company - LLC "Company BB". The line included six computed tomographs - from the 40-slice uCT 520 to the 160-slice uCT 780. The devices received a registration certificate on February 14, 2024. The registration process for MRI and PET/CT is ongoing.

In addition to them, the Dominus computed tomography system from South Korean SG HealthCare is also preparing to be launched on the Russian market.

Source: https://t.me/MedTechIndustry/1285


Other

SamSMU received a patent for the “smart” orthosis MioOrto

Samara State Medical University of the Russian Ministry of Health received a patent for the MioOrto smart orthosis device. It helps to recover faster and return to normal life after injuries or surgeries on the knee and hip joint. The orthosis was developed by employees of the NTI Competence Center “Bionic Engineering in Medicine” on the basis of Samara State Medical University.

MioOrto is a biological rehabilitation device with a software package based on a passive medical orthosis. It is equipped with sensors for automated monitoring of the rehabilitation process in the postoperative period. The smart orthosis reads the patient's muscle signals and flexion angles of the lower limb, providing accurate data on muscle function and the level of their tension. This makes it an essential tool in the recovery process after injury or surgery.

The use of a “smart” orthosis allows you to take rehabilitation to a new level - Fast track (FT), which speeds up the recovery process and reduces the time to full recovery. Sensors that record the level of muscle tension transmit the received information to a smartphone or computer in real time. Thanks to this, doctors and specialists can more accurately assess the patient’s condition and develop an individual rehabilitation program.

Source: https://samsmu.ru/news/2024/03052/

At the Physics and Technology School named after. Kurchatov came up with a biofuel method for powering heart implants

A biofuel cell for a pacemaker, which converts energy from the oxidation of glucose into electricity, was developed at the Physics and Technology School of Natural, Plasma and Nuclear Technologies named after. Kurchatova. If it is used, there will be no need for a second operation to replace lithium-ion batteries for a heart implant, the university’s website reports.

Source: https://pharmmedprom.ru/news/v-fizteh-shkole-pridumali-biotoplivnii-sposob-pitaniya-serdechnih-implantatov/

Apple Watch's Afib feature can now be used in clinical trials

The Blood Pressure (AFib) function in Apple Watch has received certification from the US Food and Drug Administration (FDA) as a device in the Medical Device Development Tools (MDDT) program, Mobihealthnews writes.

Afib Apple Watch can be used in clinical studies as a biomarker test to non-invasively assess the severity of atrial fibrillation (a type of arrhythmia), as well as to evaluate cardiac ablation devices (procedures to radically treat abnormal heart rhythms).

This move by the FDA is a true digital transformation of clinical research: wearable devices with proven health measurement accuracy can now be used to measure results in groups of subjects.

Source: https://www.mobihealthnews.com/news/fda-approves-apple-watchs-heart-monitoring-tool-use-clinical-trials


New registered medical devices

We publish a list of new medical devices registered from 05/03/2024 to 05/08/2024

Link to the list: [see. table in attachment]

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