News Digest 29.12.2023 — 09.01.2024
Regulators
Main regulatory changes in the field of medical devices from January 1, 2024
By January 1, the deadline for re-issuing licenses for medical equipment services had expired. In November 2021, the Russian Government approved a new regulation on licensing the technical maintenance of medical devices. The document excludes from regulation the service of medical devices with a low risk class, as well as legal entities or individual entrepreneurs engaged in servicing their own medical equipment.
The new version of the regulations specifies a list of equipment necessary for servicing medical equipment for each type. Companies involved in the maintenance of medical equipment had until January 1, 2024 to submit an application to Roszdravnadzor to make changes to the register in connection with updating the list of maintenance work performed.
• A new list of medical devices for the re-equipment of vascular centers will come into force. From the list, which now contains 31 positions instead of the previous 36, computed tomographs with a resolution higher than 64 slices supplied for the needs of regional vascular centers, as well as several types of rehabilitation equipment, are excluded.
• From January 1, the lists of medical products with preferential VAT have been updated. The Government of the Russian Federation has adjusted the lists of codes of medical goods subject to VAT at a tax rate of 10% when imported and sold into the Russian Federation, as well as the list of medical goods, the import and sale of which are not subject to VAT. For a number of items, the problem of simultaneous presence of goods in both lists has been eliminated. Thus, artificial teeth are excluded from the list of medical products taxed at a rate of 10%, and certain types of special absorbent underwear are additionally included in the list of non-taxable medical products.
Market news
National Medical Research Center of Oncology named after. Blokhina will receive government funding for industry research in the field of AI
The government has selected six more research centers in the field of artificial intelligence (AI), which will be actively involved in the scientific agenda for the development of this technology in the country until 2030 and will receive government support. Among them is the National Medical Research Center of Oncology named after. N.N. Blokhin, Samara University. acad. S.P. Korolev, Novosibirsk State University, National Research Nuclear University MEPhI, UNN named after. N.I. Lobachevsky, St. Petersburg State University. All applications underwent a multi-stage scientific and methodological examination.
Each winning organization will receive up to 632 million rubles for the implementation of the industry research center program on AI until 2026. The total amount of allocations for the period of the program, taking into account extra-budgetary funding, will exceed 5 billion rubles. The funds are intended for the development of specialized scientific research in the field of AI, the development of applied AI solutions implemented by industrial partners, the training of industry specialists, as well as the formation of industry data sets.
Muscovites will be given tonometers and glucometers for remote monitoring
In Moscow and the Moscow region, doctors will be able to monitor the health of patients remotely using tonometers and glucometers. This will allow you to control the course of cardiovascular diseases and diabetes. This follows from the draft government resolution prepared by the Ministry of Economic Development (Vedomosti has reviewed the document).
The expert admitted that organ design will become a separate profession in 2026
Organ designer and bioprinting engineer could become independent professions by 2026. Such specialists will develop and produce three-dimensional analogs of tissues and organs for transplantation, says Alexey Komyagin, director of the Competence Center of the National Technology Initiative (NTI) “Bionic Engineering in Medicine” at Samara State Medical University (SamSMU).
Source: https://nauka.tass.ru/nauka/19673783
Other
In the US, the regulator approved AI software for pressure-measuring underwear
Nanowear has received FDA clearance for artificial intelligence (AI)-enabled software that enables its Simplesense smart underwear to measure blood pressure. The startup bills its product as "the first non-invasive, cuffless, continuous blood pressure monitor and diagnostic device," MedTechDive reports.
Simplesense is a fabric-based underwear that wraps around the wearer's torso and one shoulder. The medical device is equipped with two ECG leads and sensors to record heart sounds and activity, as well as measure respiratory rate using thoracic impedance technology. The device allows doctors and researchers to remotely collect patient data without disrupting their lives and addressing the problem of “white coat hypertension.”
The product is equipped with Simplesense-BP software, which estimates systolic and diastolic blood pressure. Before using Simplesense, clinicians need to take a traditional blood pressure measurement to classify a patient's hypertension, and can then assess it remotely without using a traditional cuff.
Nanowear tested the technology on four categories of users, from people with normal blood pressure to those at risk of heart disease and stroke. The device's accuracy met International Organization for Standardization criteria for four weeks after calibration with no evidence of discrepancy.
Eli Lilly launches digital health system
American pharmaceutical company Eli Lilly announced the launch of the digital health system LillyDirect. The system provides patients with diabetes, obesity and migraines access to healthcare providers, educational information and an online pharmacy for select Lilly medications.
In addition, using the platform, patients will be able to find healthcare workers who are nearby. The service also offers a function for ordering medications to your home.
Apple announced the opening of sales of a new mixed reality headset for surgeons
Apple has announced the launch date for its first major product in years, Vision Pro. The mixed reality headset will cost $3.49 thousand and will be sold in Apple Stores: offline and online, according to the technology giant's website.
One of the areas of application of the new product is healthcare. The headset, which looks like ski goggles, can be useful for surgeons when performing operations. US hospital networks have reportedly expressed interest in learning more about the new technology.
Boston Scientific will acquire Axonics for $3.7 billion to develop its urology division
The American biomedical company Boston Scientific Corporation announced the acquisition of California-based Axonics, which specializes in the production of devices for the treatment of urinary and bowel dysfunction. The transaction amount will be $3.7 billion, or $71 per share. Completion of the purchase process is planned in the first half of 2024. Axonics also announced a 34% increase in net profit for 2023, to $366 million. Axonics owns 27% of the US sacral neuromodulation market. On the back of news of the deal, its stock quotes jumped 21% to $69.72 per share.
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