Over 500! The List of Hospital Construction Projects in 23 Provinces Released

Recently, medical new infrastructure construction continues to advance in various regions. The national medical investment keeps increasing, with hospital new infrastructure focusing on the expansion of large hospitals.+The quality improvement and renovation of grassroots hospitals are underway, fully unleashing expansion demands, and related medical industries are welcoming a huge incremental market. At the same time, a new round of medical equipment configuration demand is also brewing. According to incomplete statistics,2024Year already has23Province Announcement Exceeds500Key hospital construction projects, including hundreds of key projects in public medical institutions and health care facilities. Some regions have disclosed specific construction scales and investment amounts, and a number of construction projects are expected to be completed this year. (CPhI China)

2Shandong Provincial Drug Administration Issues Guidelines to Guide the Selection and Audit of Contract Manufacturing Enterprises

Recently, the Shandong Provincial Drug Administration issued two reference documents: "Shandong Province Guidelines for the Selection of Contract Manufacturing Enterprises by Marketing Authorization Holders (MAH)" and "Shandong Province Guidelines for MAHs on the Audit of Contract Manufacturing Enterprises." The "Selection Guidelines" summarize key points for selection from five aspects: general requirements, overall enterprise operations, production scale, production experience, and compatibility of similar types and dosage forms, past inspection acceptance and risk management, and other factors. The "Audit Guidelines" are mainly used to guide...BCertificate Holder to the Entrusted Production EnterpriseGMPTo review the implementation and the performance capability of relevant agreements on drug contract manufacturing, ensuringBThe quality system of the certificate holder and the entrusted production enterprise maintains continuous and effective alignment. (Shandong Drug Administration)

3Sichuan Provincial Health Commission Releases 6 Licenses for Class B Large Medical Devices in the 14th Five-Year Plan

Recently, the Health Commission of Sichuan Province announced2024Year7Month17Date2024Year7Month31Daily Administrative Approval Results. This batch of permits allows Mianyang Central Hospital to newly configure a laparoscopic surgery system.1Taiwan, Licensed Medical Linear Accelerator3Platform, LicenseXPositron Emission Tomography Scanner1Taiwan, Licensed Helical Tomotherapy Radiation Therapy System1Platform. Self2023Year6In the monthly announcement by China's National Health Commission, the 14th Five-Year Plan for the allocation of large medical equipment was revealed, with additions.559Taiwan Laparoscopic Surgery System, which was obtained in Sichuan Province during the 14th Five-Year Plan period24Zhang surgical robot configuration certificate. Sichuan has cumulatively issued the 14th Five-Year Plan surgical robot configuration certificates.7Zhang, Yu17The configuration certificate for the Zhang surgical robot has not been issued. China559Under the configuration certificate for surgical robots, currently, according to publicly available data, more than200Zhang, less than remains370Zhang not issued. (Medical Device Innovation Network)

4Johnson & Johnson's First Active Spine Robot FDA Approved

Recently, Johnson & JohnsonDePuy SynthesAnnounced the launch of a dual-purpose robot and independent navigation platform, which uses itsVelys Robotic Spine Surgery: Johnson & Johnson's Robotic Orthopedic Surgical System Velys The latest progress, the system was launched in 2021 First obtained in [Year] FDA Approval for Total Knee Surgery. This Year 6 Month,VelysObtained FDA Unicompartmental Knee Arthroplasty Approved.Velys Active Robotic Assistance System (Velys Spine), used for planning and performing spinal fusion surgeries, treating areas including the cervical spine, thoracolumbar spine, and sacroiliac spine. This dual-purpose system provides independent navigation and an active robotic platform for flexible handling and planning. The active robot can offer customized surgical guidance based on the surgeon's preferences. (Vascular.net)

5The First Artificial Intelligence Pathology Large Model PathOrchestra Released

Recently, it was learned from the Air Force Medical University that the university's pathology research team, in collaboration with Tsinghua University and SenseTime Healthcare, jointly released the first large-scale pathology model in China——PathOrchestra. This model is trained on the largest digital pathology image dataset in China and enables the widest range of clinical tasks globally, achieving a breakthrough leap in the field of AI pathology research from "single-modal specific disease" to "one-model multiple diseases." The model combines visual models with large language models, utilizing the nearly largest scale in China.3010,000 sheets, nearly300TBThe whole-slide digital pathology image dataset with a large amount of data has been trained, and multi-modal training data such as text and video have been integrated. Currently, the model has covered lung, breast, liver, esophagus, etc.20More than 100 clinical tasks, including pan-cancer classification, lesion identification and detection, and multi-cancer subtype classification, can be applied to various organs. (Science and Technology Daily)

6. FDA Releases Fee Schedule for Fiscal Year 2025, Fees Continue to Rise

Recently, the United StatesFDAPublished the "2025Fiscal Year Rate Announcement: New Drug Review Fees Increase Again30Million USD. This year10Month1As of the date, the fee for pharmaceutical companies to submit new drug applications based on clinical data will reach430Million US dollars, more than10It increased more than twofold before the year. However, for new drug applications that do not require clinical data,FDAThe cost, although only215Million US dollars, but also compared to2024Annual200Million USD has increased. Although the new drug application fee will rise, butPDUFA(Prescription Drug User Fee Act) project fees will increase from2024Year's41.67Million USD decreased to40.39Million USD. This report can be regarded as aFDAThe annual report not only summarized in the announcementFDAThe cost and number of projects for review and approval also includeFDAPersonnel compensation and the upcoming recruitment plan. (EPharmaceutical Manager)

7R&D design services accelerate the clinical transformation of medical research achievements

The research and development of medical devices is a complex and rigorous process, involving multiple aspects such as technology, regulations, and clinical practices. OssDsign has2A 10,000-square-meter Science and Innovation Center has been established, which includes a Medical Device Research Institute dedicated to the clinical transformation of medical research achievements. The institute boasts a high-level, international, multidisciplinary professional team proficient in the entire process of R&D, regulatory affairs, clinical trials, registration, and production, capable of developing and producing various complex innovative products. With extensive project experience and industry resources, it has built a standardized, regulated, and digitalized full-process service system, providing one-stop services from initial market research, product concept generation, product design and development to prototype production and testing. As of now, Osmunda has...200Multiple projects enter the review,100Multiple projects under development, with a high success rate of transformation100%.(Collected by Ossdah)

8Shenzhen officially launches online medical insurance drug purchases 

Recently, Shenzhen Medical Insurance Bureau announced the official launch of online medical insurance personal account drug purchase service. Currently, this service has covered the entire city.400Yu's Pharmacy. From placing online orders for medicines, to individual medical insurance account payments, and then to home delivery via food delivery services, this new "buy-and-get immediately" option for purchasing medicines with medical insurance will bring more convenience to Shenzhen residents. As one of the first platforms approved to launch online medical insurance medicine purchasing services, Meituan Medicine has rapidly expanded its service scale in collaboration with chain brands such as Neptunus and Dingdang Kuaiao, achieving full coverage across Shenzhen. When insured individuals in Shenzhen select medicines on Meituan Medicine, they can look for products marked with a blue "Medical Insurance Payment" label. After submitting their order, they simply choose "Medical Insurance Payment" to easily complete the purchase using their medical insurance. (Shenzhen Medical Insurance Bureau)