Global First Femtosecond Laser for Glaucoma Receives CE Mark; Abbott and Medtronic Partner on CGM Integration

1. China's National Medical Products Administration announced 36 batches of non-compliant cosmetics, of which 21 batches were facial mask products.

Recently, the National Medical Products Administration announced that 36 batches of cosmetics were found non-compliant, including two counterfeit products under the brand "Guyu." Among the 36 batches, 21 batches of face mask samples were found to have excessive levels of mold or yeast and bacterial colony counts. According to the announcement, during the 2023 national sampling inspection of cosmetics conducted by institutions such as the Tibet Autonomous Region Institute for Food and Drug Control, it was found that SAMKUS Shangguan's Arbutin Brightening Ampoule Mask and other 36 batches of cosmetics produced by Guangzhou Pujiana Biotechnology Co., Ltd. did not meet the regulations. Relevant persons in charge of Guyu stated, "All products manufactured by our company comply with national regulations. The substandard products mentioned in the notification are not produced by our company. The Market Supervision Administration of Huangpu District, Guangzhou City, has confirmed that the sampled products are counterfeit." (National Medical Products Administration)

2. China's National Medical Products Administration Cancels Registration Certificates for 2 Medical Devices

Recently, the National Medical Products Administration (NMPA) announced that, in accordance with the Regulations on the Supervision and Administration of Medical Devices, based on the enterprise's application, the NMPA has now canceled the medical device registration certificates for a total of 2 products from the following 2 companies:

One product of Hunan Hande Minimally Invasive Medical Technology Co., Ltd.: Laparoscopic High-Frequency Surgical Instruments, Registration Certificate No.: China Medical Device Registration Approval 20163010651. One product of Tsuneko Co., Ltd.: Dry Immunoassay Analyzer POCT ANALYZER MODEL, Registration Certificate No.: China Medical Device Import Registration 20192222424. (National Medical Products Administration)

3. Sichuan Province Officially Opens Full Online Processing Channel for Drug and Medical Device Advertising Review Matters

Recently, to further the "Streamline Administration, Delegate Power, and Improve Services" reform, comprehensively enhance the quality and efficiency of government services, and promote the implementation of the "Maximum One Visit" reform under the premise of "One Network for All Services," achieving "Zero Running" for more matters and providing greater convenience for businesses and the public, the Sichuan Provincial Drug Administration announced the opening of a fully online processing channel for the review of drug and medical device advertisements. Starting from August 7, 2024, applicants can log in to the Sichuan Government Service Network, complete identity verification, and submit applications online. (Sichuan Drug Administration)

4. Gansu Province: TCM Services to Cover County-Level Medical Institutions Within Three Years

Recently, the Gansu Provincial Administration of Traditional Chinese Medicine formulated and issued the "Gansu Province 'Strengthening TCM at the Grassroots Level and Revitalizing TCM in Grassroots Areas' Action Plan (2024-2027)." The action plan aims to implement eleven initiatives to build a grassroots TCM service system that integrates prevention, healthcare, disease treatment, and rehabilitation. This system will be led by county-level TCM hospitals, with grassroots healthcare institutions as the main body, supplemented by TCM departments in county-level general hospitals, specialized hospitals, and maternal and child healthcare institutions. It emphasizes a rational layout, clear division of labor, and complementary functions, striving to create a favorable situation where TCM services account for "half of the grassroots healthcare landscape" and truly strengthen TCM services at the grassroots level. The Action Plan proposes building a comprehensive grassroots TCM service system. (Daily Gansu)

5. Abbott and Medtronic Collaborate in Diabetes Care Field

Recently, Abbott and Medtronic jointly announced a significant partnership in the field of diabetes care. This collaboration aims to integrate Abbott's FreeStyle Libre CGM (FreeStyle Libre 3) product with Medtronic's automated insulin pump (MiniMed 780G) and smart insulin pen (InPen system) to co-develop a comprehensive system. This system will provide the world’s most widely used CGM, focusing on simplifying diabetes management and enabling a seamless transition to automation for those seeking greater advancements in diabetes care. As Abbott and Medtronic shift from pure competition to coopetition in the diabetes care sector, the existing market landscape is set to experience a significant impact. (CPhI Online)

6. World's First Glaucoma Femtosecond Laser Receives EU CE Approval

Recently, ViaLase's ViaLase laser has received EU CE mark approval. This laser is designed to treat adult patients with primary open-angle glaucoma. The ViaLase laser utilizes the precision of femtosecond lasers combined with micron-level image guidance for non-invasive glaucoma treatment, referred to as "flying femtosecond laser, image-guided, high-precision trabeculotomy." This technology offers patients a non-pharmaceutical, incision-free option for glaucoma treatment. Commercialization is expected later this year in selected European markets. ViaLase has established strategic distribution partnerships with Teleon Surgical in Germany and Austria, and Global Surgical Services in Spain and Portugal. Currently, the ViaLase laser is not approved for use in the United States. (Vascular Network)

7. R&D Design Services Accelerate the Clinical Transformation of Medical Scientific Research Achievements

Medical Device R&D is a complex and rigorous process involving multiple aspects such as technology, regulations, and clinical trials. Oseyda has a 20,000㎡ Science and Innovation Center and has established a Medical Device Research Institute dedicated to the clinical transformation of medical research achievements. It boasts a high-level, international, multidisciplinary professional team proficient in the entire process of R&D, regulations, clinical trials, registration, and production, capable of conducting R&D and production for various complex and innovative products. With extensive project experience and industry resources, it has built a standardized, regulated, and digitalized full-process service system. It provides one-stop services from initial market research, product concept generation, product design and development to prototype production and testing. To date, Oseyda has had over 200 projects enter the review stage, more than 100 projects under development, with a 100% success rate in transformation. (Compiled by Oseyda)

8. New AI Model for Predicting Protein Sequences Unveiled

Recently, the Swiss Federal Institute of Technology Lausanne (EPFL) developed a new artificial intelligence (AI)-driven model named CARBonAra. This model can predict protein sequences based on the backbone scaffolds constrained by different molecular environments, which is expected to bring significant advancements in protein engineering and various fields including medicine and biotechnology. The findings were published in the latest issue of *Nature Communications*. CARBonAra was trained on a dataset containing approximately 370,000 subunits. The model not only performed excellently in synthetic benchmark tests but also underwent experimental validation. Its flexibility and accuracy open new avenues for protein engineering and enhance the capabilities for future drug discovery. (Jintai News)