智通财经APP讯，正海生物(300653.SZ)公告，公司近日取得由国家药品监督管理局下发的《医疗器械注 册证》，产品名称为：钙硅生物陶瓷口腔骨修复材料。 ...

（文章来源：每日经济新闻） 每经AI快讯，1月9日，正海生物(300653.SZ)公告称，公司于近日取得国家药品监督管理局下发的《中 华人民共和国医疗器械注册证》，产品名称为钙硅生物陶瓷口腔骨修复材料，注册证编号为国械注准 20263170015，有效期至2031年1月6日。该产品适用于牙槽骨缺损修复，采用三维打印方式成型，具备 定制化生产潜力。此注册证的取得将丰富公司口腔领域产品线，提升市场竞争力。但产品上市后实际销 售情况取决于市场推广效果，对公司未来业绩的影响无法准确预测。 ...

Core Insights - Biobeat Technologies has completed a $50 million Series B funding round, approximately 350 million RMB, led by Ally Bridge Group, OrbiMed Advisors, and Elevage Medical, with participation from a strategic investor. The funds will primarily be used for the commercialization of its core product, the Biobeat non-cuff dynamic blood pressure monitoring system in the U.S. market [2] - The increasing number of hypertension patients highlights a shift in the clinical practice of dynamic blood pressure monitoring technology, with Biobeat being the first FDA-approved system for 24-hour continuous monitoring [2] Product Research Background - Hypertension is one of the most common chronic diseases, with over 100 million patients in the U.S. Despite the maturity of antihypertensive medications, adjustments in drug dosage heavily rely on physicians' assessments of patients' blood pressure [3] - Unlike diabetes management, which utilizes continuous glucose monitoring (CGM) for real-time insulin guidance, hypertension treatment lacks a similar continuous data foundation due to limitations in blood pressure monitoring methods [3] Current Monitoring Solutions - Traditional cuff-based ABPM is the most widely used device in clinical settings, consisting of a cuff, main unit, and data analysis software. While it is technically mature and included in clinical guidelines, it has limitations such as patient discomfort and low real-world usage rates [5] - Home electronic blood pressure monitors, including arm and wrist devices, are convenient but do not qualify as ABPM since they provide intermittent measurements triggered by patients, lacking continuous coverage of blood pressure variations [6] - Biobeat represents a new path with its patch-based, cuffless ABPM, allowing continuous monitoring without the discomfort of cuff inflation, aligning more closely with wearable device usage [7] Product Introduction - Biobeat's patch-based, cuffless blood pressure monitoring system enables 24-hour continuous monitoring by simply wearing a patch on the chest [8] - The system consists of a cuffless monitoring patch and accompanying mobile and computer applications, allowing patients to engage in daily activities and sleep without disruption. After monitoring, the patch can be disposed of by the patient, and reports are automatically generated and uploaded to electronic medical records [11] Company Overview - Biobeat Technologies is an innovative medical device company with operations in Tel Aviv, Israel, and Boca Raton, Florida, focusing on dynamic blood pressure monitoring. The company aims to enhance the application of ABPM among hypertension patients by capturing continuous blood pressure data while ensuring patient comfort and sleep quality [15] Conclusion - The integration of continuous blood pressure monitoring into standard clinical practices for hypertension management depends on clinical practice, physician acceptance, and payment environments. Biobeat has introduced a new technological option for dynamic blood pressure monitoring, and its practical application in clinical settings warrants ongoing attention [16]

| | | 近日， 上海微密医疗科技有限公司 自主研发的 MeshCoil ® 瘤内扰流装置 正式获得国家药品监督管理局（NMPA）批准上市 （注册证号： 国械注准 20263130001 ，注册品名：自膨式动脉瘤瘤内栓塞器)。 据悉，该产品是 我国首款获批用于治疗颅内血管分叉部宽颈动脉瘤的国产瘤内扰流装置 ，是国产神经介入器械中，少数 直接面向复杂分叉部宽颈动脉瘤适 应证 获批上市的产品之一，具有明确的适应证指向性。 | 索引号 | XZXK-2026-10006 | 主题分类 | | --- | --- | --- | | 标题 | 自膨式动脉瘤瘤内栓塞器获批上市 | | | 发布日期 | 2026-01-08 | | # 临床痛点：分叉部宽颈动脉瘤仍是介入治疗难点 在颅内动脉瘤介入治疗中，分叉部宽颈动脉瘤长期被视为高难度亚型，其挑战主要集中在以下几个方面： 在此背景下，临床始终存在一种现实需求：在保证瘤颈覆盖效果的同时，尽量减少对正常血管结构的长期干预，并降低手术路径的复杂度。 # 产品介绍：以"瘤内扰流"为核心的技术 路径技术思路与器械定位 MeshCoil ® 采用的是瘤内扰流的技术路径。与需要跨越 ...

近日，美的医疗旗下万东医疗官微发文称，由其牵头主导编制的T/CAMDI163—2025《全幅立式摄影架 技术规范》与T/CAMDI164—2025《医用X射线摄影床技术规范》两项团体标准正式发布实施。 此次实施的两项标准，精准聚焦全幅DR设备的核心基础部件，系统规定了技术要求、试验方法、产品 分类及检验标准。它们深度契合临床实际需求与产业发展现状，有效解决了该领域长期缺乏统一技术规 范的问题，为行业的设计、生产、检验全链条提供了科学依据与行动指南，有力推动我国相关产业 从"自发探索"向"标准引领"的高质量发展模式转型。 （万东医疗公众号） (编辑：杨燕 林辰)关键字： 医疗 ...

Core Insights - JD Health is set to enhance its investment in the medical device sector, focusing on supply, AI, and medical services as core drivers for growth, aiming to become a significant growth engine and launchpad for global medical device brands by 2026 [1][5] Group 1: Strategic Initiatives - JD Health signed agreements with 100 global brands to launch new products in 2026, committing over 100 million in marketing resources to ensure that new products are launched as bestsellers [1][5] - The company aims to create a comprehensive ecosystem that meets user needs across all channels and life cycles, supporting the "Healthy China 2030" strategy [1] Group 2: Market Growth and Product Innovation - The medical device market in China is projected to grow from approximately 300 billion to 500 billion, driven by aging population, health awareness, and consumption upgrades [3] - JD Health plans to deepen global collaborations and enhance domestic supply through initiatives like JDH+N alliance, targeting a 100% growth in trending categories [3] Group 3: Awards and Recognition - JD Health established a rigorous evaluation system for awarding the 2025 Golden Award for new medical devices, recognizing nearly 100 brands for their quality and reputation [5] Group 4: AI and Service Integration - JD Health is leveraging its self-developed AI model "Jingyi Qianxun" to transform product categories and define value through services, moving towards a full-cycle health management solution [7] - The company has launched customized CGM products in collaboration with brands like Yuyue and Sanofi, creating an integrated smart blood glucose management system [9] Group 5: Consumer Engagement and Service Enhancement - JD Health's AI doctor "Xiao Wei" provides comprehensive support throughout the purchasing process, achieving a user satisfaction rate of 98.4% [9] - The company is enhancing its online and offline medical services, integrating them with medical device usage scenarios to create a seamless health management experience [9]

Core Viewpoint - The medical device sector is experiencing significant growth, with key stocks showing strong performance and substantial capital inflow into related ETFs, indicating a bullish market sentiment in this industry [1][4]. Group 1: Market Performance - The CSI All-Medical Device Index (H30217) rose by 1.59%, with notable stocks such as Di'an Diagnostics (300244) hitting a 20% limit up, and Kingmed Diagnostics (603882) reaching a 10% limit up [1]. - The largest medical device ETF (159883) saw a 1.53% increase, with over 260 million yuan in capital inflow during the afternoon session [1]. - Over the past four days, the medical device ETF has experienced continuous net inflows, totaling 1.232 billion yuan, with an average daily net inflow of 308 million yuan [1]. Group 2: Key Stock Movements - Di'an Diagnostics (300244) closed at 21.72 yuan, with a 20% increase and a transaction volume of 2.198 billion yuan [2]. - Anbiping (688393) rose by 15.33% to 31.83 yuan, with a transaction volume of 308 million yuan [2]. - Kingmed Diagnostics (603882) increased by 10% to 33.66 yuan, with a transaction volume of 1.086 billion yuan [2]. Group 3: Technological and Policy Developments - Shenzhen Hanyu Pharmaceutical and Huawei Cloud launched a "Peptide AI Process Optimization Assistant," reducing R&D cycles by 45% and improving decision-making efficiency by 90% [3]. - Guangzhou's new plan emphasizes biomedicine and health as a key emerging industry, aiming to build high-level innovation platforms around cell and gene technology [3]. - The Beijing action plan for 2026-2027 aims for widespread application of AI products in healthcare institutions by 2027 [3]. Group 4: ETF Characteristics - The medical device ETF (159883) has the highest brain-computer interface content in the market, accounting for over 23%, and is the largest ETF focused on the medical device sector [4]. - The ETF includes a strong representation of innovative domestic companies, with over 80% of its components from the Sci-Tech Innovation Board and the Growth Enterprise Market [4]. - The Hong Kong medical ETF (159366) tracks the CSI Hong Kong Stock Connect Medical Theme Index, providing exposure to high-quality assets in the medical sector [4].

Group 1 - The core viewpoint of the article highlights a strong rebound in the pharmaceutical sector in 2025 after four consecutive years of decline, driven by AI and innovative drugs, reflecting a qualitative change in China's innovation capabilities and the realization of overseas expansion logic [1] - The medical device industry experienced a 3.78% decline in December, but is showing signs of recovery due to policy reforms and the resolution of industry governance challenges, with some sub-sectors reaching a fundamental turning point [1] - The CRO/CDMO sector is witnessing a resonance of domestic and international demand, with a recovery in global investment and financing leading to increased orders, alongside a gradual clearing of supply-side issues, which is expected to restore industry profitability [1] Group 2 - The National Medical Products Administration has released the "Priority Approval List for High-end Medical Devices (2025 Edition)," supporting the innovative development of high-end medical devices, indicating potential opportunities for reversing industry challenges [1] - The investment logic for the pharmaceutical sector in 2026 will continue to focus on innovation growth and the reversal of difficulties, with sub-sectors like medical devices expected to maintain a warming trend [1] - The ChiNext Pharmaceutical ETF (159377) tracks the Innovation Pharmaceutical Index (399275), which has a daily price fluctuation limit of 20%, focusing on innovative pharmaceutical fields and selecting listed companies with high R&D investment and strong innovation capabilities [1]

前有马斯克Neuralink宣布2026年量产计划，脑机接口面临量产临界。后脚国内首张非侵入式脑机接口医疗器械注册证立马跟上，正式"身份证"的落地标志着 赛道将正式从实验室走向临床与市场。 现在整个医疗器械狂掀涨停潮，迪安诊断、金域医学涨停，安必平也快了，祥生、华大、热景涨幅都在7%以上。医疗器械指数ETF（159898）的脑机接口 含量在24%左右，盘中直接被爆买了1.53亿份！！ 我宣布，脑机接口，全新赛道，筹码干净，位置跟卫星、芯片比要低得多，一片星辰大海，绝对是马年最有潜力的马斯克概念！ 目前A股市场里，纯正的"脑机接口"标的凤毛麟角。医疗器械指数ETF（159898）所跟踪的指数中，包含了约24%在脑机接口领域有实质性业务布局的上市 公司，直接提供了一个高效、便捷的指数化工具，可以布局脑机接口这一前沿赛道。 | | 医疗器械指数ETF(159898)标的指数 | | | --- | --- | --- | | 证券简称 | 所属指数权重(%) | 所属热门概念 | | 迈瑞医疗 | 14.67 | 脑机接口 | | 乐普医疗 | 2.83 | 脑机接口 | | 华大基因 | 1.84 | 脑机接口 ...

1月9日，江苏省药品监督管理局显示，麦澜德脑机接口经颅磁刺激仪取得医疗器械注册证。这不仅标志 着麦澜德在前沿医疗技术领域实现了重要突破，也标志着公司在非侵入式脑机接口产业化应用上迈出了 实质性落地的一步，同时，为公司未来的技术拓展和业绩增长打开了新的空间。 ...