格隆汇1月9日丨正海生物(300653.SZ)公布，近日取得由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：钙硅生物陶瓷口腔骨修复材料。公司产品钙硅生物陶瓷口腔骨修复材料 作为一款新型骨替代材料，实现了原料组分及结构工艺的协同创新。该产品作为钙硅基骨修复材料，通 过引入硅离子等功能元素，促进成骨分化和血管化，能够有效引导牙槽骨的修复和再生，显著提升成骨 速率和成骨质量；同时采用三维打印方式成型的制备工艺，能够实现与自体骨相近的多孔结构，这种仿 生设计不仅能够为组织提供更优异的成骨环境，还具备了定制化生产匹配患者需求的潜力，为口腔种植 修复提供了更精准、高效的解决方案。 ...

（记者 曾健辉） 每经AI快讯，安必平1月9日晚间发布公告称，今日，公司收到股东诸暨高特佳、重庆高特佳、杭州高 特佳和杭州睿泓出具的《股份减持结果告知函》，上述主体通过集中竞价交易的方式合计减持935676 股，占公司总股本的1.00%。减持计划实施完毕 每经头条（nbdtoutiao）——独家对话特斯拉FSD跨美第一人：4400公里"零接管"，手没碰过方向盘！作 为激光雷达销售员，他为何站队马斯克的"纯视觉"？ ...

正海生物（300653）(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。 ...

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].