News Digest 14.03.2025 — 21.03.2025
Regulators
The Ministry of Health has approved the Code of Ethics for the Use of Artificial Intelligence in the Industry
The Interdepartmental Working Group under the Ministry of Health of the Russian Federation on the creation, development and implementation of medical products and services using artificial intelligence technologies into clinical practice has approved the Code of Ethics for the Use of AI in Healthcare. The document consists of four chapters and covers various issues, including the need to ensure data confidentiality and comprehensive control over the AI system.
The document is necessary to regulate relations related to the ethical aspects of the development, implementation and use of technologies in the field of health care, and includes a set of principles and recommendations that apply to all stages of the life cycle of such systems, MV previously reported. According to the Ministry of Health, following the provisions of the code will help developers of AI systems create the safe and competitive solutions necessary for the industry and will increase the trust of Russians in this technology.
The provisions of the document must be applied at all stages of the life cycle of AI systems, including planning, design, model building, verification and validation, deployment, operation and monitoring, taking into account the mandatory definition of decommissioning criteria.
Market news
Russian developer creates implantable cardioverter-defibrillator for 293 million
Russian company Palekh Engineering (Skolkovo resident) has developed the first domestic implantable cardioverter-defibrillator (ICD). The process of creating the medical device took 2.5 years, the company invested 292.5 million rubles of its own funds in the development. The ICD has already passed preclinical trials. The operator intends to technically refine the device, and then begin its mass production in Russia and the BRICS countries. In the future, Palekh Engineering intends to invest 1 billion rubles in the certification and registration of the device, its introduction into clinical practice. The ICD continuously monitors the heart rhythm and, in the case of life-threatening arrhythmias, delivers a powerful electric shock, restoring normal heart function. Specialists from the Federal Scientific and Clinical Center (FSCC) of the Federal Medical and Biological Agency of Russia and the Moscow Regional Scientific and Clinical Institute named after M.F. Vladimirsky participated in the creation of the device. The development has been tested on animals, and the technical parameters are currently being optimized. According to the developers, the “unique technological advantage” of the domestic defibrillator over foreign analogues is its software algorithms. The chief engineer of the project, Alexander Chistov, noted that this parameter “has shown effectiveness in the studies conducted, and now we are bringing it to perfection.” One of the promising solutions, he emphasized, will be the use of artificial intelligence (AI) “as a second backup system for discriminating life-threatening arrhythmias and other software algorithms of the device.” Thus, according to Chistov, AI will be able to give recommendations to the doctor on changing certain ICD parameters during a routine check of the device. The specialist noted that in the future it is planned to optimize the dimensions of the device and increase the battery capacity - in this case, the ICD "will work smoothly for at least 10 years."
Moscow Region to purchase medical equipment for oncology dispensaries for 565 million rubles
The Ministry of Health of the Moscow Region intends to contract at least 600 units of medical equipment by the end of 2025 to equip oncology dispensaries and oncology departments in the clinics of the region. According to the head of the regional Ministry of Health Maxim Zabelin, the total purchase bill will be at least 565 million rubles.
The purchase plan includes video endoscopic equipment, as well as surgical, diagnostic and other equipment. The devices will be shipped to the Moscow Regional Oncology Dispensary, Vidnovskaya, Lobbenskaya, Reutovskaya, Shaturskaya and other hospitals.
Source: https://t.me/vademecum_live/17424
Other
FDA has issued permission for an app for epileptics on Apple Watch
The company EpiWatch, which has developed an app for tracking epileptic seizure symptoms, has received permission from the US Food and Drug Administration (FDA) to use the service for medical purposes. During testing, it was found that the program detects seizures with a low rate of false alarms.
Devices such as smartwatches and headphones are increasingly being used to monitor consumers' health indicators and predict potential health problems. In February, tech giant Google received FDA approval for its AI-powered pulse loss detection technology, available in the Pixel Watch 3. The feature checks a person's pulse, and as soon as it detects signs of losspulse, the device activates infrared and red light to search for additional pulse signals. The motion sensor then checks for signs of movement, and if none are detected, the watch calls emergency services and sends data about the user's condition and location to the operator.
New registered medical devices
We publish a list of new medical devices registered from 03.14.2025 to 03.21.2025
Link to the list: [see table in the attachment]
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