Workflow
全自动细胞形态学分析仪
icon
Search documents
深圳市市场监管局谱写监管领域综合改革创新示范新篇章
Group 1 - Shenzhen has launched the first national data intellectual property registration service platform and issued the first AI digital human data intellectual property certificates [1][9] - The market supervision bureau has established a mechanism for cultivating innovative products and has been approved for the first AI medical device for cell morphology analysis [1][3] - Shenzhen's market supervision system has implemented five comprehensive reform pilot tasks and has promoted 11 specific reform initiatives nationwide [2][11] Group 2 - The establishment of the first data intellectual property service trust in Shenzhen aims to activate the value of intellectual property and data assets through financial innovation [2][9] - Shenzhen has created a five-in-one overseas intellectual property protection system, providing one-on-one guidance to 2,320 enterprises and recovering over $16 billion in market losses [3][7] - The city has also established a "Hong Kong-Macao drug and device通" real-world research platform, with 75 urgently needed drug and device types approved for implementation [3][6] Group 3 - Shenzhen's market supervision bureau has organized a city-wide roadshow for key innovative medical device projects, with 27 projects participating [4][5] - The bureau has achieved significant results in the approval process for AI medical devices, including the approval of the first AI medical device for cell morphology analysis [5][6] - The city has built a WHO-PQ certified laboratory and established a precise service mechanism for drug supervision and inspection, enhancing its capabilities [6][7] Group 4 - Shenzhen has made significant advancements in the inspection level of biological products, with over 20 new qualifications for cell and gene therapy products [7][8] - The city has optimized the clinical trial mechanism, reducing the average time from project initiation to launch to just 73.27 days [8][11] - The establishment of the first national data intellectual property registration service platform has resulted in the issuance of 1,725 certificates and facilitated 106 million yuan in financing [9][10] Group 5 - The AI medical device industry in Shenzhen is rapidly developing, with over 20% of national AI medical enterprises located in the city [12] - Shenzhen is expected to continue generating replicable and promotable innovative experiences, contributing to high-quality urban development and modernizing market supervision [12][11] - The city has established a collaborative mechanism with Hong Kong's health authorities to explore cross-border data recognition and regulatory cooperation [11][12]
最新!2款创新器械获批上市!
思宇MedTech· 2025-08-26 07:26
Core Insights - The article highlights the approval of two innovative medical devices in China: the "Fully Automatic Cell Morphology Analyzer" by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and the "X-ray Computed Tomography Equipment" by Neusoft Medical Systems Co., Ltd. [1][2] Group 1: Product Overview - The Fully Automatic Cell Morphology Analyzer is designed for classifying and counting white blood cells and nucleated red blood cells from human peripheral blood samples, enhancing accuracy in identifying abnormal samples through advanced imaging and deep learning technologies [3]. - The X-ray Computed Tomography Equipment, NeuViz P10, is noted as China's first photon counting CT and the world's first 8cm wide photon counting CT, utilizing a novel detection method for improved resolution and lower radiation doses [9][11]. Group 2: Company Profiles - Mindray Medical, established in 1991 and headquartered in Shenzhen, is the largest medical device manufacturer in China, with a global presence in 31 countries and a strong focus on patient monitoring, in vitro diagnostics, and medical imaging systems [5]. - Neusoft Medical, founded in 1998, is a core medical imaging equipment company under Neusoft Group, providing a wide range of imaging solutions and services, and has products in over 110 countries [12]. Group 3: Financial Performance - In 2024, Mindray reported an annual revenue of 36.73 billion yuan, a year-on-year increase of 5.1%, with a net profit of 11.67 billion yuan, reflecting a growth of 0.7% [7]. - For the first quarter of 2025, Mindray's revenue was 8.24 billion yuan, showing a decline of 12% year-on-year, with a net profit of 2.63 billion yuan, down 16.7% [7].