News Digest 25.10.2024 — 01.11.2024

Regulators

Roszdravnadzor has included 11 items in the list of alcohol-containing products

The Roszdravnadzor commission has updated the list of alcohol-containing medical products that are not covered by the Federal Law "On state regulation of the production and circulation of ethyl alcohol, alcoholic and alcohol-containing products and on limiting the consumption (drinking) of alcoholic products". Decision No. 1 of 11.10.2024 is published on the service's website.

The list includes 11 medical products out of 15 proposed. Eight of them are reagents for PCR studies and DNA/RNA extraction developed and manufactured by the Central Research Institute of Epidemiology of Rospotrebnadzor. The other two medical products are kits for DNA/RNA extraction from biomaterial "AmpliTest" manufactured by the Central Scientific Research Institute of the Federal Medical and Biological Agency of Russia and a reagent for fixing cytological preparations "MLT-Fixator-spray" manufactured by MLT LLC.

Two products manufactured by Neocor CJSC were refused inclusion in the list due to their inappropriateness. These are the KemPlus universal xenopericardial surgical mesh and the NeoRing support ring for annuloplasty.

Eight medical products were recommended to be excluded from the list (out of 40 proposed). Seven of them are test systems for conducting PCR studies to detect RNA of hepatitis viruses, borrelia, chlamydia, influenza viruses A and B, as well as auxiliary reagents produced by the Central Research Institute of Epidemiology of Rospotrebnadzor. Another medical product is reagents from the Chinese vendor Hunan Lituo Biotechnology, a subsidiary of Lituo Biotech.

Source: https://pharmvestnik.ru/content/news/Roszdravnadzor-vkluchil-v-perechen-spirtosoderjashih-izdelii-11-pozicii.html

Market news

Analysts announced stabilization of price growth for medical equipment in September

RNC Pharma presented data on inflation in the medical equipment market for September 2024. There is a price increase for January-September at the level of 9.2% compared to the same period in 2023. The maximum growth was recorded in the category of glucometers. Price dynamics in other categories of medical equipment, including test strips for glucometers, nebulizers, thermometers and tonometers, also showed various trends with differences between online and offline sales channels.

Source: https://pharmvestnik.ru/content/news/Analitiki-zayavili-o-stabilizacii-rosta-cen-na-medtehniku-v-sentyabre.html

Participants in a cartel on the drug and medical products market in Yakutia were released from punishment

A Yakutsk court found four defendants guilty in a case of fraud and cartel collusion in the supply of drugs and medical products to clinics in the region in 2016-2019. The illegal income of the convicted persons was estimated at 350 million rubles. The names of the defendants are not disclosed. They were given suspended sentences of 4 to 5 years with release from punishment due to the expiration of the statute of limitations for criminal liability.

Source: https://vademec.ru/news/2024/11/01/uchastnikov-kartelya-na-rynke-lekarstv-i-medizdeliy-v-yakutii-osvobodili-ot-nakazaniya/

Other

In Moscow, a neural network has learned to detect gallstone disease

An artificial intelligence (AI) service has been launched in the capital that detects signs of gallstone disease on computed tomography (CT). The neural network can find stones in the gallbladder and measure them. It is planned that this will automate and speed up the diagnostic process, the Center for Diagnostics and Telemedicine of the Moscow Department of Health reported.

Before starting work in real conditions, the service was tested to detect stones in the gallbladder. The algorithm does not recognize other changes as deviations. The Telemedicine Center stated that the use of computer vision technologies in this area will help reduce the time for diagnosis and increase its accuracy.

Source: https://medvestnik.ru/content/news/V-Moskve-neiroset-nauchilas-vyyavlyat-jelchnokamennuu-bolezn.html

Ophthalmic surgeons have implemented a service with AI to calculate lenses for cataract surgeries

A module for a medical information system (MIS) based on artificial intelligence (AI) has been implemented in the Volgograd branch of the S.N. Fedorov National Medical Research Center for Scientific and Technical Complex "Microsurgery of the Eye" to select the optical power for an intraocular lens, which is used to replace a clouded lens of the eye with a cataract. The use of the LensCalc service can increase the effectiveness of such surgical interventions to 91%, Alexander Zubkov, head of the Visdom laboratory at the Volgograd State Technical University (VolSTU), told TASS.

Source: https://medvestnik.ru/content/news/Oftalmohirurgi-vnedrili-servis-s-II-dlya-rascheta-linz-dlya-operacii-pri-katarakte.html

Scientists from Science Corp. completely restored vision to patients with the help of an implant

Developers of the brain-computer interface (BCI) from the American company Science Corporation announced the preliminary results of clinical trials of their Prima retinal implant. It allowed to completely restore vision to patients.

The Prima implant was implanted in 38 participants in the trial a year ago. All of them had lost their central visual field due to geographic atrophy. As a result, the subjects were able to read and clearly recognize faces. On average, patients were able to see 23 letters on the chart (red line), and the maximum improvement was 59 letters (blue line). Scientists are already working on bringing the implant to market.

Source: https://t.me/medicalksu/5315

Newly registered medical devices

We publish a list of new medical devices registered from 10.25.2024 to 11.01.2024

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