截至2026年2月3日 13:14，中证医药及医疗器械创新指数(931484)上涨0.57%，成分股爱美客上涨 4.07%，健帆生物上涨2.36%，新和成上涨2.29%，浙江医药上涨2.09%，新产业上涨1.73%。医疗创新 ETF(516820)上涨0.57%，最新价报0.36元。 消息面上，近日，由武汉经开区企业武汉市龙点睛智能科技有限公司自主研发的"龙点睛穿刺手术导航 设备"，正式通过国家药品监督管理局（NMPA）三类医疗器械审批，获准上市，标志着国内首款人工 智能经皮穿刺导航机器人正式获批上市，国产人工智能技术在临床治疗领域实现了从'辅助诊断'向'辅助 治疗'的又一次跨越。 华金证券指出，AI在智慧医疗领域应用已较为成熟，尤其在医学影像诊断中可辅助医生提高判读效 率；而在医药研发端，AI可通过虚拟筛选加速化合物发现，并预测药效与安全性，降低研发成本与风 险。近期多项AI医疗产品加速落地，如迪安诊断旗下"宫颈细胞数字病理图像辅助诊断软件"于2026年1 月获批三类医疗器械注册证，联影医疗"元智"大模型在复杂病灶诊断任务中精准度超95%，迈瑞医 疗"启元重症大模型"亦已投入临床应用。技术迭代叠加政策支持， ...

华金证券发布研报称，AI已渗透医疗全产业链。智慧医疗，尤其是医学影像，是当前最成熟的应用领 域之一，AI制药能显著提升研发效率。当前，技术迭代与政策支持正共同驱动市场高速增长。随着国 产AI医疗大模型及医疗器械产品加速获批落地，产业景气度持续向上，为相关企业带来发展机遇。 多部委陆续出台政策推动人工智能在医疗领域应用落地，国家药监局2025年6月审议通过《关于优化全 生命周期监管支持高端医疗器械创新发展的举措》，首次将"人工智能医疗器械"列为四大重点发展领 域，各地方政策试点陆续推进。技术端来看，DeepSeekR1等开源大模型推动医疗AI开发成本大幅下 降，加速AI技术商业化落地。据观研数据显示，医疗保健板块人工智能解决方案的全球市场规模预计 将由2022年的137亿美元增至2030年的1553亿美元，CAGR为35.5%。技术催化叠加政策推动，国内 AI+医疗市场有望迎来高速增长。 申万医药表现较强，跑赢沪深300 近两周申万医药指数下跌3.68%，跑输沪深300指数3.14pp。近两周申万医药指数在31个一级行业中排名 第30位。从子板块来看，线下药店、血液制品、原料药表现靠前，近两周变动分别为 4.3 ...

Core Viewpoint - BGI Genomics (688114) has announced that its self-developed pathological slide staining scanner PMIF-20 has passed medical device registration tests, marking a significant step in clinical application and enhancing the integration of pathology analysis with artificial intelligence [1] Group 1: Product Development and Market Impact - The PMIF-20 is an efficient fully automated staining imaging platform that provides comprehensive and accurate spatial proteomics data for tumor immune microenvironment research, showcasing its value in AI pathology analysis and scientific exploration [2] - The PMIF-20 integrates FluoXpert multi-immune fluorescence (mIF) technology, focusing on automating the staining and scanning of tissue slices, maintaining consistent performance with the FluoXpert multi-omics analyzer set to launch in 2024 [3] - BGI Genomics has developed core algorithms for deep learning cell segmentation, multi-round image registration, signal deconvolution, and background fluorescence removal, forming a complete AI analysis system for multi-fluorescence stained images of pathological slices [3] Group 2: Industry Trends and Competitive Position - The AI healthcare sector is experiencing a surge, with significant developments such as OpenAI's ChatGPT Health feature and Ant Group's Alipay reaching over 30 million monthly active users, raising market expectations for the integration of AI and life sciences [1] - BGI Genomics is the only company globally that covers three sequencing technology paths and has evolved into a comprehensive multi-omics tool provider that fully integrates AI technology into life science tools [4] - Recent regulatory approvals for AI-assisted diagnostic tools, such as the cervical cell digital pathology image diagnostic software by Dian Diagnostics, indicate a new phase of large-scale application in pathology AI diagnostics, supported by favorable policies [4]

Group 1 - The core point of the article is that Wanfu Biology announced the approval of its investment in Saiweisen Technology's "Cervical Cell Digital Pathology Image Assisted Diagnosis Software," marking a significant milestone in the field of cervical cytology with the first AI-assisted diagnosis Class III product registration in the country [1] - The AI-assisted reading of slides significantly enhances diagnostic efficiency and accuracy, providing more precise treatment plans for patients [1] - Saiweisen is committed to offering a comprehensive solution for intelligent pathology AI-assisted diagnosis and aims to continue innovating in the pathology AI field, promoting the digital transformation of the industry [1]

Core Viewpoint - The company has made significant advancements in the AI sector, particularly in the field of cervical cytology, with the approval of an AI-assisted diagnostic software, marking a milestone in digital pathology [2] Company Summary - Wanfu Biology (300482.SZ) announced on July 30 that its investment in Saiweisen Technology's "Cervical Cell Digital Pathology Image Assisted Diagnosis Software" has received formal approval, becoming the first AI-assisted diagnostic Class III product registration in the national cervical cytology field [2] - This approval signifies a new milestone for the "Digital Pathology + AI Assistance" model, which enhances diagnostic efficiency and accuracy through AI-assisted slide reading, providing more precise treatment plans for patients [2] - Saiweisen is committed to offering a comprehensive solution for intelligent pathology AI-assisted diagnosis, and with the company's support, it will continue to deepen its focus on the pathology AI field, driving the development and application of more innovative technologies [2] Industry Summary - The approval of the AI-assisted diagnostic software is expected to contribute to the digital transformation of the pathology industry, providing higher quality and smarter pathology solutions for doctors and patients [2]