News Digest 27.10.2023-30.10.2023

Regulators

Roszdravnadzor will establish a procedure for issuing extracts from the register of medical devices

Roszdravnadzor proposed to establish a procedure for issuing to the applicant an extract from the state register of medical devices and organizations that are involved in their production and manufacturing. The corresponding draft order is posted on the regulation.gov.ru portal. The purpose of the document is to approve the legal regulation of the procedure for issuing information contained in the register, the explanatory note says.

According to the document, individuals, legal entities, individual entrepreneurs, state authorities and local governments will be able to order an extract. The maximum period for its provision is five working days from the date of registration (reception) of the corresponding request. To receive an extract, you will need documents confirming the authority of the applicant’s representative to act on his behalf, as well as a request in any form. The draft order contains a sample of how to fill it out.

Source: https://pharmvestnik.ru/content/news/Roszdravnadzor-ustanovit-poryadok- vydachi -vypiski-iz-reestra-medizdelii.html?utm_source=TGFV_post&utm_medium=Group&utm_campaign=Roszdravnadzor-ustanovit-poryadok-vydachi-vypiski-iz-reestra-medizdelii

Market news

The Ministry of Industry and Trade assessed the share of domestic medical products in dentistry

“Russian manufacturers have registered dental burs, dental implants and components, grinding discs, filling material, cutters, cement. According to independent agencies, the share of domestically produced medical products for dentistry is about 20% of the market volume of medical products of the corresponding range,” the ministry said .

The Ministry of Industry and Trade emphasized that fillings and anesthesia, implants and other consumables used in dental clinics are produced by domestic manufacturers in significant volumes. For example, the total production volume of medical products for dentistry in Russia at the end of 2022 increased by 40.1% in value terms and by 45.2% in physical terms compared to the previous year.

In addition, there are currently 153 registration certificates in force in the country for the production of medical products for dentistry, the holders of which are 47 Russian organizations, which is 29.5% of the total number of registration certificates.

Source: https://ria.ru/20231023/stomatologiya-1904576643.html

Other

Scientists have developed a highly integrated bionic arm with neural control and feedback that can be used in everyday life

In 2020, an international team of scientists developed a bionic hand that can perform 80% of the tasks of a real human hand. In this case, the device completely fuses with the patient’s bone tissue and becomes part of the human body. Recently, researchers published the results of their experiment. They tested the bionic arm on a 50-year-old Swedish woman, Karin, who lost her arm 20 years ago in an accident.

Karin was one of the first patients to participate in the DeTOP project, an extensive European Union-funded study aimed at developing the next generation of bionic limbs. To improve the functionality of the device, surgeons performed osseointegration, which during surgery attached the bone directly to the implant, creating a stronger mechanical connection. They also implanted electrodes into the muscles and nerves of the patient's arm. The result is a robotic limb that is directly connected to Karin's neuromuscular system. Like a real flesh-and-blood hand, it is controlled by Karin's nervous system and provides sensory feedback. Her arm can perform about 80% of the daily tasks that a normal limb can do, which has greatly improved Karin's quality of life.

Source: https://www.science.org/doi/10.1126/scirobotics.adf7360

Aspen Medical Products Introduces Fully Integrated Spinal Trauma Support System

The VRTX system is considered the first cervical to sacral system designed to transform spine care in the acute care setting.

It consists of prefabricated CTO, TLSO, LSO and CTLSO, each of which provides optimal motion restriction that can be adjusted to meet specific patient requirements.

The prefabricated, easily adjustable design helps clinicians fit patients and stabilize the spine.

It is a turnkey solution that can improve time and inventory management by reducing hospital stays, reducing the risk of complications and increasing operational efficiency.

To maximize patient care and staff efficiency, the new modular solution allows for standardization of products and services across the hospital.

Source: https://www.medicaldevice-network.com/news/aspen-integrated-trauma-spinal-support-system/?cf-view