新闻内容:[ { "id": 32, "pubishDate": null, "title": "喜讯|药明康德中国医疗器械测试中心通过CNAS评审", "locale": "zh-CN", "published_at": "2021-12-17T06:03:50.000Z", "created_at": "2021-12-17T05:51:01.000Z", "updated_at": "2021-12-17T06:03:50.000Z", "content": null, "date": "2019-11-06", "test": null, "newsContent": "\n11月2日和3日,药明康德中国医疗器械测试中心(苏州)接受了中国合格评定国家认可委员会现场评审并顺利通过,此次评审主要集中在医疗器械测试中心的能力扩项,审查员推荐包括生物相容性、化学、微生物方向的在医疗器械、药品包装材料、药品和药用原辅料三个领域共计32项的检测能力。", "url": "https://mp.weixin.qq.com/s/hwq0m_USDg04BZXAyfh_bw", "image": { "id": 536, "name": "喜讯_药明康德中国医疗器械测试中心通过CNAS评审.png", "alternativeText": "", "caption": "", "width": 310, "height": 175, "formats": { "thumbnail": { "name": "thumbnail_喜讯_药明康德中国医疗器械测试中心通过CNAS评审.png", "hash": "thumbnail_CNAS_ba91aa078b", "ext": ".png", "mime": "image/png", "width": 245, "height": 138, "size": 96.22, "path": null, "url": "/uploads/thumbnail_CNAS_ba91aa078b.png" } }, "hash": "CNAS_ba91aa078b", "ext": ".png", "mime": "image/png", "size": 114.24, "url": "/uploads/CNAS_ba91aa078b.png", "previewUrl": null, "provider": "local", "provider_metadata": null, "created_at": "2021-12-13T03:40:27.000Z", "updated_at": "2021-12-13T03:40:27.000Z" } }, { "id": 33, "pubishDate": null, "title": "喜报 | 药明康德零缺陷通过!顺利获得A2LA的USFDA GLP和ISO17025认证证书", "locale": "zh-CN", "published_at": "2021-12-17T06:03:52.000Z", "created_at": "2021-12-17T05:51:36.000Z", "updated_at": "2021-12-21T07:43:44.000Z", "content": null, "date": "2021-06-17", "test": null, "newsContent": "2021年6月4日,药明康德测试事业部苏州药明康德医疗器械测试中心顺利获得了A2LA的USFDA GLP和ISO17025资质证书。\n苏州药明康德医疗器械测试中心于2021年5月10日至5月14日,接受了美国认可机构A2LA的评审,此次评审覆盖了测试中心体系运行及测试能力的各个方面,最终以零缺陷通过,这是对苏州药明康德医疗器械测试中心的相关检测能力和运营体系的极大肯定。苏州药明康德医疗器械测试中心将继续致力于为客户提供高水准的医疗器械产品测试和咨询,为全球医疗器械行业的发展服务。\n\n\n\n 至此,苏州药明康德医疗器械测试中心已取得了欧盟成员国比利时OECD GLP、CMA、CNAS的ISO17025、ISO13485、及A2LA的USFDA GLP和ISO17025的资质认定,进一步夯实了出具同时满足NMPA、FDA、CE和OECD成员国注册申报的测试报告能力,实现“一份报告,全球申报”。", "url": "https://mp.weixin.qq.com/s/-U1d7sfw5X7WY-IxItPMmg", "image": { "id": 480, "name": "640-3.webp", "alternativeText": "", "caption": "", "width": 213, "height": 153, "formats": null, "hash": "640_3_e622a3f407", "ext": ".webp", "mime": "image/webp", "size": 5.63, "url": "/uploads/640_3_e622a3f407.webp", "previewUrl": null, "provider": "local", "provider_metadata": null, "created_at": "2021-12-12T03:24:05.000Z", "updated_at": "2021-12-12T03:24:05.000Z" } }, { "id": 34, "pubishDate": null, "title": "医疗器械创新研发智造-张江生命科学沙龙成功举办", "locale": "zh-CN", "published_at": "2021-12-17T06:03:55.000Z", "created_at": "2021-12-17T05:52:33.000Z", "updated_at": "2021-12-17T06:03:55.000Z", "content": null, "date": "2021-05-13", "test": null, "newsContent": "2021年5月12日,由上海国际医学园区主办,药明康德测试事业部、康德弘翼、药明津石和张江医谷孵创联合承办。论坛汇聚了近300位医疗器械行业精英,围绕“医疗器械创新研发智造”进行了深入的交流,为园区、行业及企业间的融通合作营造了良好氛围。会议同时也得到了中国医疗器械行业协会、上海市医疗器械检验研究院、上海胸科医院、颐道资本、睿刀医疗科技、捷迈邦美、蓝帆医疗和康沣生物科技等鼎力协助,从技术前沿、技术成果转化、一站式配套服务、资本机遇及政策法规等方面进行了精彩的分享。\n\n 上海国际医学院园区戴月明副总经理做致辞,上海国际医学园区作为张江科学城生命健康产业的重要组成部分,形成以“医”为核心,以“医疗、医养、医药、医械、医学”为一体的“五医融合”发展模式,园区重点布局高端医疗服务与医疗器械及生物医药产业,其高端医疗服务、精准医疗、高端医械研发制造对的技术领先度和发展势头均在上海乃至全国前列。园区现已汇集医疗器械企业超过400家,积累了良好的产业基础,全力以赴打造具有世界影响力的生命健康产业集群,最后戴总祝愿本次沙龙取得圆满成功。", "url": "https://mp.weixin.qq.com/s/TXgLf_Ownd6odNrmrKcLww", "image": { "id": 483, "name": "640-1.webp", "alternativeText": "", "caption": "", "width": 1080, "height": 459, "formats": { "thumbnail": { "name": "thumbnail_640-1.webp", "hash": "thumbnail_640_1_4097b2ffb3", "ext": ".webp", "mime": "image/webp", "width": 245, "height": 104, "size": 6.78, "path": null, "url": "/uploads/thumbnail_640_1_4097b2ffb3.webp" }, "large": { "name": "large_640-1.webp", "hash": "large_640_1_4097b2ffb3", "ext": ".webp", "mime": "image/webp", "width": 1000, "height": 425, "size": 42.31, "path": null, "url": "/uploads/large_640_1_4097b2ffb3.webp" }, "medium": { "name": "medium_640-1.webp", "hash": "medium_640_1_4097b2ffb3", "ext": ".webp", "mime": "image/webp", "width": 750, "height": 319, "size": 30.32, "path": null, "url": "/uploads/medium_640_1_4097b2ffb3.webp" }, "small": { "name": "small_640-1.webp", "hash": "small_640_1_4097b2ffb3", "ext": ".webp", "mime": "image/webp", "width": 500, "height": 213, "size": 18.05, "path": null, "url": "/uploads/small_640_1_4097b2ffb3.webp" } }, "hash": "640_1_4097b2ffb3", "ext": ".webp", "mime": "image/webp", "size": 48.76, "url": "/uploads/640_1_4097b2ffb3.webp", "previewUrl": null, "provider": "local", "provider_metadata": null, "created_at": "2021-12-12T03:27:19.000Z", "updated_at": "2021-12-12T03:27:19.000Z" } }, { "id": 35, "pubishDate": null, "title": "药品/医疗器械相关微生物测试", "locale": "zh-CN", "published_at": "2021-12-17T06:03:58.000Z", "created_at": "2021-12-17T05:53:17.000Z", "updated_at": "2023-03-09T07:12:45.000Z", "content": null, "date": "2021-05-17", "test": null, "newsContent": "2021年第五届PIMF将于5月20-21日在杭州宝盛水博源大酒店举办。药明康德将在B-15展位恭候您的莅临参观与交流。PIMF论坛是中国制药工业微生物学术领域中参会规模,学术水平和专业性水准较高的行业会议。\n\n药明康德 - 医疗器械测试中心微生物实验室拥有ISO 13485、CNAS、CMA、FDA GLP及OECD GLP资质,可为药品、医疗器械和生命科学客户提供全方位微生物测试:", "url": "https://mp.weixin.qq.com/s/GAMXbMV-luLwWfoP-0jFlg", "image": { "id": 482, "name": "640.webp", "alternativeText": "", "caption": "", "width": 1080, "height": 292, "formats": { "thumbnail": { "name": "thumbnail_640.webp", "hash": "thumbnail_640_b805c54486", "ext": ".webp", "mime": "image/webp", "width": 245, "height": 66, "size": 4.73, "path": null, "url": "/uploads/thumbnail_640_b805c54486.webp" }, "large": { "name": "large_640.webp", "hash": "large_640_b805c54486", "ext": ".webp", "mime": "image/webp", "width": 1000, "height": 270, "size": 32.43, "path": null, "url": "/uploads/large_640_b805c54486.webp" }, "medium": { "name": "medium_640.webp", "hash": "medium_640_b805c54486", "ext": ".webp", "mime": "image/webp", "width": 750, "height": 203, "size": 23.19, "path": null, "url": "/uploads/medium_640_b805c54486.webp" }, "small": { "name": "small_640.webp", "hash": "small_640_b805c54486", "ext": ".webp", "mime": "image/webp", "width": 500, "height": 135, "size": 13.61, "path": null, "url": "/uploads/small_640_b805c54486.webp" } }, "hash": "640_b805c54486", "ext": ".webp", "mime": "image/webp", "size": 35.34, "url": "/uploads/640_b805c54486.webp", "previewUrl": null, "provider": "local", "provider_metadata": null, "created_at": "2021-12-12T03:26:29.000Z", "updated_at": "2021-12-12T03:26:29.000Z" } }, { "id": 36, "pubishDate": null, "title": "药明康德医疗器械测试参展2021(第十一届)植入介入医疗器械创新峰会", "locale": "zh-CN", "published_at": "2021-12-17T06:04:01.000Z", "created_at": "2021-12-17T05:53:59.000Z", "updated_at": "2021-12-17T06:04:01.000Z", "content": null, "date": "2021-07-17", "test": null, "newsContent": "荣格植入介入医疗器械创新峰会一直专注于医疗器械细分领域的骨科植入,心血管介入,口腔种植市场,已经成功举办十届。今年,会议将于7月22-23日在苏州举行,重点围绕产业政策、市场机遇、研发与材料、生产制造等专题展开讨论,帮助企业在后疫情时期调整研发策略,优化产品性能,提升生产效率,实现从“量变”到“质变”的突破。\n\n\n\n 今年药明康德医疗器械测试事业部将会有现场展台展示(展位号#31),并且在大会22号上午的政策与市场主会场请到了药明康德医疗器械测试中心生物相容性实验室及法规事务部主任左楠先生分享题为《基于生物学风险管理的医疗器械生物学评价》的主题演讲。药明康德医疗器械测试事业部期待与您相聚在苏州!", "url": null, "image": { "id": 478, "name": "640.webp", "alternativeText": "", "caption": "", "width": 842, "height": 575, "formats": { "thumbnail": { "name": "thumbnail_640.webp", "hash": "thumbnail_640_f96db1a874", "ext": ".webp", "mime": "image/webp", "width": 228, "height": 156, "size": 9.04, "path": null, "url": "/uploads/thumbnail_640_f96db1a874.webp" }, "medium": { "name": "medium_640.webp", "hash": "medium_640_f96db1a874", "ext": ".webp", "mime": "image/webp", "width": 750, "height": 512, "size": 43.26, "path": null, "url": "/uploads/medium_640_f96db1a874.webp" }, "small": { "name": "small_640.webp", "hash": "small_640_f96db1a874", "ext": ".webp", "mime": "image/webp", "width": 500, "height": 341, "size": 26.19, "path": null, "url": "/uploads/small_640_f96db1a874.webp" } }, "hash": "640_f96db1a874", "ext": ".webp", "mime": "image/webp", "size": 50.25, "url": "/uploads/640_f96db1a874.webp", "previewUrl": null, "provider": "local", "provider_metadata": null, "created_at": "2021-12-12T03:22:17.000Z", "updated_at": "2021-12-12T03:22:17.000Z" } }, { "id": 37, "pubishDate": null, "title": "药明康德医疗器械测试参展第二十五届中国国际口腔器材展览会 DenTech China 2021", "locale": "zh-CN", "published_at": "2021-12-17T06:04:04.000Z", "created_at": "2021-12-17T05:55:28.000Z", "updated_at": "2021-12-17T06:04:04.000Z", "content": null, "date": "2021-10-27", "test": null, "newsContent": "由中国国际科技交流中心、上海交通大学医学院附属第九人民医院和上海博星展览有限公司共同举办的“第二十五届中国国际口腔器材展览会暨学术研讨会”(DenTech China 2021),即“上海口腔展2021”将于2021年11月3日至11月6日在上海世博展览馆举办。逾50,000平方米展览面积,来自世界22个国家和地区的850家展商入驻,感受前沿的牙科技术,享受优质的一站式服务。同期学术会议,计划邀请到约200位演讲嘉宾,就行业的热点话题及面临的具体问题展开演讲。\n\n 今年药明康德医疗器械测试事业部将会有现场展台展示(展位号:1号馆,C25、C56),欢迎前来参观。", "url": "https://mp.weixin.qq.com/s/fV_UXEwoJkqXJFUEgdIqFg", "image": { "id": 476, "name": "640.webp", "alternativeText": "", "caption": "", "width": 803, "height": 358, "formats": { "thumbnail": { "name": "thumbnail_640.webp", "hash": "thumbnail_640_0d46de0400", "ext": ".webp", "mime": "image/webp", "width": 245, "height": 109, "size": 6.78, "path": null, "url": "/uploads/thumbnail_640_0d46de0400.webp" }, "medium": { "name": "medium_640.webp", "hash": "medium_640_0d46de0400", "ext": ".webp", "mime": "image/webp", "width": 750, "height": 334, "size": 28.32, "path": null, "url": "/uploads/medium_640_0d46de0400.webp" }, "small": { "name": "small_640.webp", "hash": "small_640_0d46de0400", "ext": ".webp", "mime": "image/webp", "width": 500, "height": 223, "size": 17.62, "path": null, "url": "/uploads/small_640_0d46de0400.webp" } }, "hash": "640_0d46de0400", "ext": ".webp", "mime": "image/webp", "size": 30.97, "url": "/uploads/640_0d46de0400.webp", "previewUrl": null, "provider": "local", "provider_metadata": null, "created_at": "2021-12-12T03:15:06.000Z", "updated_at": "2021-12-12T03:15:06.000Z" } }, { "id": 38, "pubishDate": null, "title": "药明康德医疗器械测试参展第四届骨科应用材料及工艺技术研讨会", "locale": "zh-CN", "published_at": "2021-12-17T06:04:07.000Z", "created_at": "2021-12-17T05:56:22.000Z", "updated_at": "2021-12-17T06:04:07.000Z", "content": null, "date": "2021-07-05", "test": null, "newsContent": "第四届骨科应用材料及工艺技术研讨会将于2021年7月14-15日在江苏省常州市钟楼区中吴宾馆隆重举行。\n今年药明康德医疗器械测试事业部将会有现场展台展示(展位号#55),并且在大会14号下午的检测和法规分会场请到了药明康德医疗器械测试中心生物相容性实验室及法规事务部主任左楠先生分享题为《基于生物学风险管理的医疗器械生物学评价》的主题演讲。\n\n", "url": "https://mp.weixin.qq.com/s/os7nOPni5w6N-uLF24sITQ", "image": { "id": 479, "name": "640-2.webp", "alternativeText": "", "caption": "", "width": 1080, "height": 675, "formats": { "thumbnail": { "name": "thumbnail_640-2.webp", "hash": "thumbnail_640_2_6e5aaae4c6", "ext": ".webp", "mime": "image/webp", "width": 245, "height": 153, "size": 4.05, "path": null, "url": "/uploads/thumbnail_640_2_6e5aaae4c6.webp" }, "large": { "name": "large_640-2.webp", "hash": "large_640_2_6e5aaae4c6", "ext": ".webp", "mime": "image/webp", "width": 1000, "height": 625, "size": 28.49, 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"2021-12-17T06:04:10.000Z", "content": null, "date": "2021-10-12", "test": null, "newsContent": "由国药励展主办,众行业协会、学会、基金会、科研院校等机构支持的第85届中国国际医疗器械(秋季)博览会(以下简称“CMEF”)、第32届中国国际医疗器械设计与制造技术(秋季)展览会(以下简称“ICMD”),定于2021年10月13日至16日在深圳国际会展中心(宝安区)举行。本届展会以“创新科技,智领未来”为主题。\n\n 本届CMEF整体展览及会议面积近20万平方米,届时3000多家品牌企业将携数万款产品集中亮相,预计吸引超8万名专业观众到场参观。同期召开的50余场论坛和会议,将会有200余位业界大咖、行业菁英和意见领袖,为全球健康产业带来一场才智交融、观点碰撞的医疗盛宴。\n\n 今年药明康德医疗器械测试事业部将会有现场展台展示(展位号:16号馆,16G39),欢迎前来参观。", "url": "https://mp.weixin.qq.com/s/aXTaBfIIYQRJYKF8-rZKEQ", "image": { "id": 477, "name": "640-1.webp", "alternativeText": "", "caption": "", "width": 1080, "height": 526, "formats": { "thumbnail": { "name": "thumbnail_640-1.webp", "hash": "thumbnail_640_1_62fc7f4d61", "ext": ".webp", "mime": "image/webp", "width": 245, "height": 119, "size": 8.5, "path": null, "url": "/uploads/thumbnail_640_1_62fc7f4d61.webp" }, "large": { "name": "large_640-1.webp", "hash": "large_640_1_62fc7f4d61", "ext": ".webp", "mime": "image/webp", "width": 1000, "height": 487, 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"2021-12-17T06:04:12.000Z", "content": null, "date": "2021-11-20", "test": null, "newsContent": "2021第四届E&L中国年会将于 2021 年 11 月 23-24 日回到中国上海,探讨最新的技术进步、法规更新、药物包装新材料的分析进展、医疗和药物器械组合产品的新发展等更多话题!本次大会将对市场和全球监管新格局进行深入解析,同时为辩论和交流提供大量时间。\n\n 今年药明康德医疗器械测试将设有现场展台展示(展位号#6),欢迎前来参观。", "url": "https://mp.weixin.qq.com/s/v-wAfkb6Tfk1yONL7wI5_g", "image": { "id": 475, "name": "640.webp", "alternativeText": "", "caption": "", "width": 785, "height": 341, "formats": { "thumbnail": { "name": "thumbnail_640.webp", "hash": "thumbnail_640_94ded3d5c1", "ext": ".webp", "mime": "image/webp", "width": 245, "height": 106, "size": 5.02, "path": null, "url": "/uploads/thumbnail_640_94ded3d5c1.webp" }, "medium": { "name": "medium_640.webp", "hash": "medium_640_94ded3d5c1", "ext": ".webp", "mime": "image/webp", "width": 750, "height": 326, "size": 19.53, "path": null, "url": "/uploads/medium_640_94ded3d5c1.webp" }, "small": { "name": "small_640.webp", "hash": "small_640_94ded3d5c1", "ext": ".webp", "mime": 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近日,中共中央办公厅、国务院办公厅印发了《关于加强科技伦理治理的意见》,并发出通知,要求各地区各部门结合实际认真贯彻落实。\n\n《关于加强科技伦理治理的意见》全文如下。\n\n科技伦理是开展科学研究、技术开发等科技活动需要遵循的价值理念和行为规范,是促进科技事业健康发展的重要保障。当前,我国科技创新快速发展,面临的科技伦理挑战日益增多,但科技伦理治理仍存在体制机制不健全、制度不完善、领域发展不均衡等问题,已难以适应科技创新发展的现实需要。为进一步完善科技伦理体系,提升科技伦理治理能力,有效防控科技伦理风险,不断推动科技向善、造福人类,实现高水平科技自立自强,现就加强科技伦理治理提出如下意见。\n\n一、总体要求\n\n(一)指导思想。以习近平新时代中国特色社会主义思想为指导,深入贯彻党的十九大和十九届历次全会精神,坚持和加强党中央对科技工作的集中统一领导,加快构建中国特色科技伦理体系,健全多方参与、协同共治的科技伦理治理体制机制,坚持促进创新与防范风险相统一、制度规范与自我约束相结合,强化底线思维和风险意识,建立完善符合我国国情、与国际接轨的科技伦理制度,塑造科技向善的文化理念和保障机制,努力实现科技创新高质量发展与高水平安全良性互动,促进我国科技事业健康发展,为增进人类福祉、推动构建人类命运共同体提供有力科技支撑。\n\n(二)治理要求\n\n——伦理先行。加强源头治理,注重预防,将科技伦理要求贯穿科学研究、技术开发等科技活动全过程,促进科技活动与科技伦理协调发展、良性互动,实现负责任的创新。\n\n——依法依规。坚持依法依规开展科技伦理治理工作,加快推进科技伦理治理法律制度建设。\n\n——敏捷治理。加强科技伦理风险预警与跟踪研判,及时动态调整治理方式和伦理规范,快速、灵活应对科技创新带来的伦理挑战。\n\n——立足国情。立足我国科技发展的历史阶段及社会文化特点,遵循科技创新规律,建立健全符合我国国情的科技伦理体系。\n\n——开放合作。坚持开放发展理念,加强对外交流,建立多方协同合作机制,凝聚共识,形成合力。积极推进全球科技伦理治理,贡献中国智慧和中国方案。\n\n二、明确科技伦理原则\n\n(一)增进人类福祉。科技活动应坚持以人民为中心的发展思想,有利于促进经济发展、社会进步、民生改善和生态环境保护,不断增强人民获得感、幸福感、安全感,促进人类社会和平发展和可持续发展。\n\n(二)尊重生命权利。科技活动应最大限度避免对人的生命安全、身体健康、精神和心理健康造成伤害或潜在威胁,尊重人格尊严和个人隐私,保障科技活动参与者的知情权和选择权。使用实验动物应符合“减少、替代、优化”等要求。\n\n(三)坚持公平公正。科技活动应尊重宗教信仰、文化传统等方面的差异,公平、公正、包容地对待不同社会群体,防止歧视和偏见。\n\n(四)合理控制风险。科技活动应客观评估和审慎对待不确定性和技术应用的风险,力求规避、防范可能引发的风险,防止科技成果误用、滥用,避免危及社会安全、公共安全、生物安全和生态安全。\n\n(五)保持公开透明。科技活动应鼓励利益相关方和社会公众合理参与,建立涉及重大、敏感伦理问题的科技活动披露机制。公布科技活动相关信息时应提高透明度,做到客观真实。\n\n三、健全科技伦理治理体制\n\n(一)完善政府科技伦理管理体制。国家科技伦理委员会负责指导和统筹协调推进全国科技伦理治理体系建设工作。科技部承担国家科技伦理委员会秘书处日常工作,国家科技伦理委员会各成员单位按照职责分工负责科技伦理规范制定、审查监管、宣传教育等相关工作。各地方、相关行业主管部门按照职责权限和隶属关系具体负责本地方、本系统科技伦理治理工作。\n\n(二)压实创新主体科技伦理管理主体责任。高等学校、科研机构、医疗卫生机构、企业等单位要履行科技伦理管理主体责任,建立常态化工作机制,加强科技伦理日常管理,主动研判、及时化解本单位科技活动中存在的伦理风险;根据实际情况设立本单位的科技伦理(审查)委员会,并为其独立开展工作提供必要条件。从事生命科学、医学、人工智能等科技活动的单位,研究内容涉及科技伦理敏感领域的,应设立科技伦理(审查)委员会。\n\n(三)发挥科技类社会团体的作用。推动设立中国科技伦理学会,健全科技伦理治理社会组织体系,强化学术研究支撑。相关学会、协会、研究会等科技类社会团体要组织动员科技人员主动参与科技伦理治理,促进行业自律,加强与高等学校、科研机构、医疗卫生机构、企业等的合作,开展科技伦理知识宣传普及,提高社会公众科技伦理意识。\n\n(四)引导科技人员自觉遵守科技伦理要求。科技人员要主动学习科技伦理知识,增强科技伦理意识,自觉践行科技伦理原则,坚守科技伦理底线,发现违背科技伦理要求的行为,要主动报告、坚决抵制。科技项目(课题)负责人要严格按照科技伦理审查批准的范围开展研究,加强对团队成员和项目(课题)研究实施全过程的伦理管理,发布、传播和应用涉及科技伦理敏感问题的研究成果应当遵守有关规定、严谨审慎。\n\n四、加强科技伦理治理制度保障\n\n(一)制定完善科技伦理规范和标准。制定生命科学、医学、人工智能等重点领域的科技伦理规范、指南等,完善科技伦理相关标准,明确科技伦理要求,引导科技机构和科技人员合规开展科技活动。\n\n(二)建立科技伦理审查和监管制度。明晰科技伦理审查和监管职责,完善科技伦理审查、风险处置、违规处理等规则流程。建立健全科技伦理(审查)委员会的设立标准、运行机制、登记制度、监管制度等,探索科技伦理(审查)委员会认证机制。\n\n(三)提高科技伦理治理法治化水平。推动在科技创新的基础性立法中对科技伦理监管、违规查处等治理工作作出明确规定,在其他相关立法中落实科技伦理要求。“十四五”期间,重点加强生命科学、医学、人工智能等领域的科技伦理立法研究,及时推动将重要的科技伦理规范上升为国家法律法规。对法律已有明确规定的,要坚持严格执法、违法必究。\n\n(四)加强科技伦理理论研究。支持相关机构、智库、社会团体、科技人员等开展科技伦理理论探索,加强对科技创新中伦理问题的前瞻研究,积极推动、参与国际科技伦理重大议题研讨和规则制定。\n\n五、强化科技伦理审查和监管\n\n(一)严格科技伦理审查。开展科技活动应进行科技伦理风险评估或审查。涉及人、实验动物的科技活动,应当按规定由本单位科技伦理(审查)委员会审查批准,不具备设立科技伦理(审查)委员会条件的单位,应委托其他单位科技伦理(审查)委员会开展审查。科技伦理(审查)委员会要坚持科学、独立、公正、透明原则,开展对科技活动的科技伦理审查、监督与指导,切实把好科技伦理关。探索建立专业性、区域性科技伦理审查中心。逐步建立科技伦理审查结果互认机制。\n\n建立健全突发公共卫生事件等紧急状态下的科技伦理应急审查机制,完善应急审查的程序、规则等,做到快速响应。\n\n(二)加强科技伦理监管。各地方、相关行业主管部门要细化完善本地方、本系统科技伦理监管框架和制度规范,加强对各单位科技伦理(审查)委员会和科技伦理高风险科技活动的监督管理,建立科技伦理高风险科技活动伦理审查结果专家复核机制,组织开展对重大科技伦理案件的调查处理,并利用典型案例加强警示教育。从事科技活动的单位要建立健全科技活动全流程科技伦理监管机制和审查质量控制、监督评价机制,加强对科技伦理高风险科技活动的动态跟踪、风险评估和伦理事件应急处置。国家科技伦理委员会研究制定科技伦理高风险科技活动清单。开展科技伦理高风险科技活动应按规定进行登记。\n\n财政资金设立的科技计划(专项、基金等)应加强科技伦理监管,监管全面覆盖指南编制、审批立项、过程管理、结题验收、监督评估等各个环节。\n\n加强对国际合作研究活动的科技伦理审查和监管。国际合作研究活动应符合合作各方所在国家的科技伦理管理要求,并通过合作各方所在国家的科技伦理审查。对存在科技伦理高风险的国际合作研究活动,由地方和相关行业主管部门组织专家对科技伦理审查结果开展复核。\n\n(三)监测预警科技伦理风险。相关部门要推动高等学校、科研机构、医疗卫生机构、社会团体、企业等完善科技伦理风险监测预警机制,跟踪新兴科技发展前沿动态,对科技创新可能带来的规则冲突、社会风险、伦理挑战加强研判、提出对策。\n\n(四)严肃查处科技伦理违法违规行为。高等学校、科研机构、医疗卫生机构、企业等是科技伦理违规行为单位内部调查处理的第一责任主体,应制定完善本单位调查处理相关规定,及时主动调查科技伦理违规行为,对情节严重的依法依规严肃追责问责;对单位及其负责人涉嫌科技伦理违规行为的,由上级主管部门调查处理。各地方、相关行业主管部门按照职责权限和隶属关系,加强对本地方、本系统科技伦理违规行为调查处理的指导和监督。\n\n任何单位、组织和个人开展科技活动不得危害社会安全、公共安全、生物安全和生态安全,不得侵害人的生命安全、身心健康、人格尊严,不得侵犯科技活动参与者的知情权和选择权,不得资助违背科技伦理要求的科技活动。相关行业主管部门、资助机构或责任人所在单位要区分不同情况,依法依规对科技伦理违规行为责任人给予责令改正,停止相关科技活动,追回资助资金,撤销获得的奖励、荣誉,取消相关从业资格,禁止一定期限内承担或参与财政性资金支持的科技活动等处理。科技伦理违规行为责任人属于公职人员的依法依规给予处分,属于党员的依规依纪给予党纪处分;涉嫌犯罪的依法予以惩处。\n\n六、深入开展科技伦理教育和宣传\n\n(一)重视科技伦理教育。将科技伦理教育作为相关专业学科本专科生、研究生教育的重要内容,鼓励高等学校开设科技伦理教育相关课程,教育青年学生树立正确的科技伦理意识,遵守科技伦理要求。完善科技伦理人才培养机制,加快培养高素质、专业化的科技伦理人才队伍。\n\n(二)推动科技伦理培训机制化。将科技伦理培训纳入科技人员入职培训、承担科研任务、学术交流研讨等活动,引导科技人员自觉遵守科技伦理要求,开展负责任的研究与创新。行业主管部门、各地方和相关单位应定期对科技伦理(审查)委员会成员开展培训,增强其履职能力,提升科技伦理审查质量和效率。\n\n(三)抓好科技伦理宣传。开展面向社会公众的科技伦理宣传,推动公众提升科技伦理意识,理性对待科技伦理问题。鼓励科技人员就科技创新中的伦理问题与公众交流。对存在公众认知差异、可能带来科技伦理挑战的科技活动,相关单位及科技人员等应加强科学普及,引导公众科学对待。新闻媒体应自觉提高科技伦理素养,科学、客观、准确地报道科技伦理问题,同时要避免把科技伦理问题泛化。鼓励各类学会、协会、研究会等搭建科技伦理宣传交流平台,传播科技伦理知识。\n\n各地区各有关部门要高度重视科技伦理治理,细化落实党中央、国务院关于健全科技伦理体系,加强科技伦理治理的各项部署,完善组织领导机制,明确分工,加强协作,扎实推进实施,有效防范科技伦理风险。相关行业主管部门和各地方要定期向国家科技伦理委员会报告履行科技伦理监管职责工作情况并接受监督。", 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"2022-03-29T01:47:20.000Z" } }, { "id": 50, "pubishDate": null, "title": "华芯医疗完成A+轮数亿元战略融资,鱼跃医疗和盛宇投资共同投资,凯乘资本连续担任独家财务顾问", "locale": "zh-CN", "published_at": "2022-04-07T06:17:12.000Z", "created_at": "2022-04-07T06:17:08.000Z", "updated_at": "2022-04-07T06:17:12.000Z", "content": null, "date": "2022-04-07", "test": null, "newsContent": "近日,湖南省华芯医疗器械有限公司(简称“华芯医疗”)宣布完成数亿元A+轮战略融资,由鱼跃医疗和盛宇投资共同投资。凯乘资本(WinX Capital)连续担任独家财务顾问。\n\n作为产业投资人,鱼跃医疗不仅能为华芯医疗提供资金方面的支持,也能在产业资源和运营管理等方面助力华芯医疗的发展。本轮融资之后,华芯医疗将进一步扩大产能,加快销售渠道的全球化布局,华芯医疗将不断丰富产品管线,未来半年,将会有多款重磅产品全球上市。\n\n华芯医疗是全球一次性内窥镜领导者,奥林巴斯是华芯医疗在美国的总代理商,另还与波士顿科学、TKB等世界知名公司合作,公司产品进入全球数十个发达国家市场并获得爆发式订单。\n\n公司一次性电子支气管镜拥有FDA、CE、NMPA及日本和韩国等全球多国/地区注册证,2021年10月,公司一次性电子支气管镜获得国内首张注册证,意味着华芯产品即将进入国内市场,打造新的增长极。2022年3月1日,公司自主研发的“医用内窥镜图像处理器”于美国获批上市,极大地夯实了华芯医疗全球一次性内窥镜领导者的地位,同时标志着华芯布局全球市场取得了里程碑式的胜利。\n\n经过国际市场检验,华芯医疗一次性电子支气管镜系统主要技术经济指标均已达到国际同类产品先进水平,产品竞争力不言而喻。在新冠疫情反复的当下,可避免交叉感染、采购成本低廉、操作程序简单的一次性电子支气管镜优势凸显,已成为助力抗击新冠肺炎的重要产品。\n\n放眼未来,一次性内窥镜对于重复性内窥镜的取代成为必然趋势,在部分应用场景下一次性内窥镜是刚需,预计到2025年全球内窥镜市场销售额国内千亿级,全球万亿级,在此期间,一次性内窥镜必将占据越来越广阔的市场空间。\n\n华芯医疗始终专注于一次性电子内窥镜产品的研发、生产和销售,产品管线全覆盖呼吸科、消化科、肛肠科、骨科等领域,拥有完善的研发–产品–市场销售闭环体系,借助核心技术突破,在保持全球高端品质的同时,实现了低成本、耗材化,可进行专用性的产品集成和创新迭代,势必将引领内窥镜的技术变革。\n\n对于本次融资,华芯医疗创始人表示:感谢鱼跃医疗和盛宇投资的战略投资,华芯医疗坚持提升关键技术和前端组件自主研发能力,以及全流程的生产能力,同时领先在全球建设销售渠道,未来将推出一系列具有创新性和差异化竞争力的爆款产品。\n\n盛宇投资表示:盛宇投资始终立足于围绕临床获益的科室解决方案布局有内核技术的平台型项目。华芯作为国内一次性内镜的头部平台型企业,其一次性内镜产品覆盖ICU、床旁诊疗、日间手术等场景,提高了基层医院内镜使用可及性。盛宇投资看好华芯所从事的领域,作为战略投资方,盛宇愿意长期陪同公司发展及成长,助力华芯成为国际领先的一次性内镜平台公司。\n\n鱼跃医疗表示:鱼跃医疗始终坚持“帮患者减轻痛苦,助医生提升医术”的使命,积极推动建立惠及人类健康的医疗技术和设备的生态圈。华芯医疗是中国在一次性内窥镜领域的技术先驱,推动和拓展该技术应用在呼吸,泌尿,消化等专科检查和治疗的新应用场景。鱼跃非常荣幸能够在未来携手华芯共同推进新一代内窥镜技术在医学多场景中的协作,推动中国医学事业发展。\n\n凯乘资本创始人邹国文博士表示:华芯医疗是全球一次性内窥镜领导者,获得奥林巴斯等全球顶级厂商合作背书,已经进入欧美日等几十个发达国家市场并获得爆发式订单。出海能力,是衡量企业竞争优势的关键指标,我们很荣幸担任华芯医疗的长期资本合作伙伴。\n\n关于华芯医疗\n\n湖南省华芯医疗器械有限公司成立于2018年,总部位于湖南省湘潭市九华经济技术开发区(湖南省医疗器械产业园)。公司专注于一次性内窥镜的研发、生产和销售,产品主要为呼吸科、消化科、肛肠科、骨科等科室的无菌内窥镜,并已获取数十项专利认证。公司一次性支气管镜获得美国FDA注册证、欧洲CE注册证以及日本和韩国等国家的注册证和ISO13485体系认证。长期以来,公司坚守“精益求精”的医疗追求。恪守“诚信立足,创新致远”公司信念。坚持追求、研发、生产更高质量的一次新内窥镜医疗器械,让健康触手可及。\n", "url": null, "image": { "id": 1039, "name": "th.jfif", "alternativeText": "", "caption": "", "width": 384, "height": 237, "formats": { "thumbnail": { "name": "thumbnail_th.jfif", "hash": "thumbnail_th_d0492ba958", "ext": ".jfif", "mime": "image/jpeg", "width": 245, "height": 151, "size": 8.13, "path": null, "url": "/uploads/thumbnail_th_d0492ba958.jfif" } }, "hash": "th_d0492ba958", "ext": ".jfif", "mime": "image/jpeg", "size": 16.91, "url": "/uploads/th_d0492ba958.jfif", "previewUrl": null, "provider": "oss", "provider_metadata": null, "created_at": "2022-04-07T06:16:08.000Z", "updated_at": "2022-04-07T06:16:08.000Z" } }, { "id": 51, "pubishDate": null, "title": "髋关节置换手术导航定位系统获批上市", "locale": "zh-CN", "published_at": "2022-04-11T05:51:40.000Z", "created_at": "2022-04-11T05:51:38.000Z", "updated_at": "2022-04-11T05:51:40.000Z", "content": null, "date": "2022-04-11", "test": null, "newsContent": " 近日,国家药品监督管理局经审查,批准了杭州键嘉机器人有限公司生产的“髋关节置换手术导航定位系统”创新产品注册申请。发布时间:2022-04-07\n  该产品由机械臂系统、光学定位系统、导航控制系统、术前规划软件、脚踏开关、加密装置、附件组成。仅与经验证的髋关节假体和手术工具联合使用,在成人髋关节置换手术过程中用于手术工具和髋关节假体的导航定位。\n  该产品核心技术主要包括空间配准、机械臂控制、安全边界控制等技术。在髋关节置换手术中应用七自由度机械臂作业并具有安全边界控制功能,辅助医生完成髋臼打磨、股骨截骨、髋关节假体安装等工作,与传统人工髋关节置换术相比,可以保证手术定位精度,减轻不良事件和并发症的发生概率,降低X射线对医生和患者的辐射损伤。\n  该产品属于具有自主知识产权的国内首创医疗器械,各项性能指标达到国际同品种器械水平。\n  药品监督管理部门将加强该产品上市后监管,保护患者用械安全。\n", "url": null, "image": { "id": 1040, "name": "th.jfif", "alternativeText": "", "caption": "", "width": 384, "height": 237, "formats": { "thumbnail": { "name": "thumbnail_th.jfif", "hash": "thumbnail_th_8083803f48", "ext": ".jfif", "mime": "image/jpeg", "width": 245, "height": 151, "size": 5.88, "path": null, "url": "/uploads/thumbnail_th_8083803f48.jfif" } }, "hash": "th_8083803f48", "ext": ".jfif", "mime": "image/jpeg", "size": 11.71, "url": "/uploads/th_8083803f48.jfif", "previewUrl": null, "provider": "oss", "provider_metadata": null, "created_at": "2022-04-11T05:51:32.000Z", "updated_at": "2022-04-11T05:51:32.000Z" } }, { "id": 52, "pubishDate": null, "title": "归创通桥-B(02190.HK):国家药监局批准颈动脉球囊扩张导管在中国上市", "locale": "zh-CN", "published_at": "2022-04-12T02:14:35.000Z", "created_at": "2022-04-12T02:14:31.000Z", "updated_at": "2022-04-12T02:14:35.000Z", "content": null, "date": "2022-04-12", "test": null, "newsContent": " 归创通桥-B(02190.HK)公告,公司自主研发的用于治疗颈动脉狭窄的颈动脉球囊扩张导管已获得中国国家药品监督管理局(国家药监局)的上市批准。本产品为公司于2022年从国家药监局获得的首个批准,预计2022年内将有另外8个产品获国家药监局批准。\n\n  本产品与颅内PTA球囊扩张导管(Rx)共同在球囊成型及制造平台上研发及制造,其承继了备受医生认可并且作为医生治疗颅内狭窄重要治疗器械之一的颅内球囊优秀的通过性、到达能力及良好回抱,其将能够进一步满足颈动脉及其他狭窄性病变在临床治疗的需求。\n\n  随着颈动脉狭窄管线首个产品的推出,公司正式进军这个充满机遇的领域。颈动脉狭窄是缺血性卒中最常见的成因之一。由于人们的健康意识提高,加上国内的神经介入技术发展迅速,越来越多患者选择进行预防性筛查并及早治疗颈动脉狭窄,相关市场因而于近年迎来急速增长。", "url": null, "image": { "id": 1041, "name": "explore-our-medical-solutions.jpg", "alternativeText": "", "caption": "", "width": 1920, "height": 970, "formats": { "thumbnail": { "name": "thumbnail_explore-our-medical-solutions.jpg", "hash": "thumbnail_explore_our_medical_solutions_c81649d8db", "ext": ".jpg", "mime": "image/jpeg", "width": 245, 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"近日,深圳市赛禾医疗技术有限公司(下称“赛禾医疗”)宣布完成数亿元A轮融资,所筹资金将用于进一步扩充研发管线、扩大产能、临床试验,及现有产品的市场推广和教育等。\n</br>\n</br>\n赛禾医疗成立于2020年4月,总部位于深圳,公司深耕泛血管疾病领域,致力于成为国际领先的植介入医疗器械平台。公司已组建起一支来自于知名医疗器械及ICT企业的研发团队,在生物材料、电子工程等领域拥有丰富经验。\n</br>\n</br>\n公司自主研发的国内首个冠状动脉冲击波碎石系统已率先开始临床入组,进展迅速。冠状动脉冲击波碎石系统包括冲击波冠脉球囊导管和体内冲击波治疗仪(包括主机和操作手柄)。操作手柄分别与冲击波冠脉球囊导管和主机连接,通过其控制键能够控制主机启动或停止血管内碎石治疗,具备良好的安全性、便捷性和可靠性。\n</br>\n</br>\n复杂冠脉病变包括CTO病变、左主干病变、多支架病变、严重钙化病变等,其中钙化病变经常贯穿于各种复杂病变,增加了冠状动脉介入治疗的难度,是心血管介入医师所面临的主要挑战之一。目前可用的钙化病变处理方式包括非顺应性球囊、切割球囊、冠状动脉斑块旋磨、准分子激光冠状动脉斑块消蚀术(ELCA)等。\n</br>\n</br>\n血管内冲击波碎石系统作为一项新技术,其在工作原理上区别于传统的钙化病变治疗技术,可以在病变处释放非聚焦的脉冲式声压力波,高效安全地压裂钙化斑块而不损坏血管内膜,进而能够使血管钙化病变得到充分扩张,起到“隔山打牛”的效果。此外,血管内冲击波碎石术学习曲线极短,适用范围广,无论是左主干病变、成角病变、支架膨胀不全,还是环形、偏心钙化以及浅表、深层钙化等,都展现出明显优势。冲击波球囊在顺应性和对抗高阻力病变之间达到完美平衡,此项技术被2021版《冠状动脉钙化病变诊治中国专家共识》称为冠状动脉钙化病变的“终结者”。\n</br>\n</br>\n截至目前,赛禾医疗已累计申请各类专利70余项,集成电路布图设计登记证书20余项,打破了国际医疗器械巨头在该领域的技术垄断。在完成现有产品研发的同时,公司建立起围绕超声技术和医学传感器的诊疗一体化的平台,在诊断领域自研血管内超声(IVUS)和心腔内超声(ICE),填补国产产品在该领域内的空白。\n</br>\n</br>\n赛禾医疗联合创始人兼CEO刘斌先生曾任职于华为技术,多年从事通信及半导体技术研究和技术应用,具备深厚行业技术背景,拥有发明专利20余项。同时他还是一位连续创业者,在科技创新、团队管理和商业应用方面拥有丰富经验。\n</br>\n对于本轮融资成功,刘斌先生表示:“感谢新老股东对赛禾医疗的认可和支持。在过去的一年中,赛禾医疗实现了产品从“0”到“1”的突破,突破底层技术研发和临床入组,并完成了深厚的技术储备。未来在技术进步和政策的支持下,我们将提高一流医疗器械的普惠性,实现赛禾医疗的社会效益。同时继续推进研发,打造完善的产品组合,穿透多科室微创诊疗场景,打造有源泛血管疾病诊疗一体化平台。”", 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"2022-04-13T07:17:57.000Z" } }, { "id": 54, "pubishDate": null, "title": "VenusP-Valve(TM)获欧盟CE MDR认证上市,国产瓣膜首登欧洲市场", "locale": "zh-CN", "published_at": "2022-04-13T07:57:49.000Z", "created_at": "2022-04-13T07:27:10.000Z", "updated_at": "2022-04-13T08:05:20.000Z", "content": null, "date": "2022-04-13", "test": null, "newsContent": "2022年4月8日,启明医疗自主研发的创新器械 -- 经导管人工肺动脉瓣膜置换(TPVR)系统VenusP-ValveTM获欧盟CE MDR认证,批准上市销售,用于治疗伴有或不伴有右心室流出道(RVOT)狭窄的中重度肺动脉瓣反流患者。此次获批,开启了国产人工瓣膜登陆欧洲市场的先河,标志着中国创新器械国际化迈向新高度。\n\n作为欧洲首个获批上市的自膨胀式TPVR产品,VenusP-ValveTM具备显著的临床价值。其独特的双喇叭口设计,锚定稳定,释放简便,植入前无需预先放置固定支架。瓣膜尺寸规格多,适用范围广,在临床上可以满足超过 85% 患者的需求。自2013年由复旦大学附属中山医院心内科主任葛均波院士实施首例临床手术至今,VenusP-ValveTM的临床使用已有9年,出于人道主义救助的临床使用近300例,覆盖亚洲、欧洲、北美洲、南美洲,遍及20多个国家及地区。2021年3月,该产品获得英国药品和医疗保健品管理局(MHRA)授予的特殊使用许可,可在指定医疗机构进行使用。\n\n中重度肺动脉瓣反流常见于先天性心脏病纠治术后,将导致右心室容量负荷增加,长期可引发心律失常甚至猝死。传统的开胸植入人工肺动脉瓣手术难度大,风险大,死亡率较高。而欧洲已上市的TPVR产品,均为球囊扩张型瓣膜,仅能覆盖特殊解剖结构的患者,且须预先植入固定支架,此外其瓣膜直径较小,仅能解决约15%至20%的患者需求。在VenusP-ValveTM获批之前,市场上尚无一款针对不同解剖形态、尺寸规格覆盖范围更广的治疗产品。\n\n优异的临床数据证明了VenusP-ValveTM长期的安全性和有效性。欧洲两年期临床研究数据显示,临床手术操作成功率达100%,两年内未出现再次手术或死亡。中度肺动脉瓣反流从术前16.88%降至0%,重度肺动脉瓣反流从83.12%大幅降至1.54%。数据表明,该产品性能优异,安全可靠,对于患者心功能的改善显著、稳定且持续。\n\n尤其值得一提的是,根据欧盟官网公示信息,VenusP-ValveTM是首个在CE MDR新法规下获批的III类心血管植入类医疗器械。欧盟自2021年5月实施CE MDR新法规,大幅提高和细化了技术评审及临床评价等各方面的要求,并新增了临床专家委员会(Expert Panel)审评等程序,此前尚未有任何III类心血管植入类医疗器械按照CE MDR批准上市。VenusP-ValveTM此次获批,充分体现出启明医疗的临床研究、质量控制等体系已达到国际先进水平。\n\n欧洲市场是启明医疗国际化战略的桥头堡,针对VenusP-ValveTM的获批上市,公司已提前进行了商业化部署及高端人才聘用,陆续任命了Shakeel Osman,David Breant等具有丰富营销经验的专家担任高管。截至目前,VenusP-ValveTM已获得数百万欧元的预订销售金额。\n\n除欧洲之外,该产品在中国也已处于NMPA注册审评阶段,有望2022年内获批上市;同时还在筹备美国FDA IDE申报,计划2023年在美国启动正式临床试验。此次欧洲的顺利获批,也将显著推动VenusP-ValveTM在中国、美国等市场的上市。\n\n英国伦敦伊芙琳娜儿童医院Shakeel Qureshi教授作为VenusP-ValveTM欧洲CE临床研究PI,对VenusP-ValveTM在欧洲获批上市表示祝贺。\"依然记得2016年9月,我们在英国伦敦正式启动VenusP-ValveTM CE 认证首台临床试验,术后的即刻效果非常优异;在这之后,我们顺利地持续入组病例,整体临床结果凸显了VenusP-ValveTM对于患者心功能的改善持续,有效和稳定,这是一款真正造福医患的创新产品。\"\n\n启明医疗联合创始人,执行董事兼总经理訾振军表示:\"VenusP-ValveTM的CE MDR获批上市,为公司进军欧洲市场开启崭新篇章。我们将以VenusP-ValveTM为商业化抓手,促进海外市场营收上量,加速启明医疗海外市场的蓬勃发展。公司也将继续推进其它创新技术和产品的全球临床和上市工作,将中国创新真正推向全球。\"", "url": null, "image": { "id": 1044, "name": "image_821354_40137978.jpg", "alternativeText": "", "caption": "", "width": 598, "height": 336, "formats": { "thumbnail": { "name": "thumbnail_image_821354_40137978.jpg", "hash": "thumbnail_image_821354_40137978_3d3405f155", "ext": ".jpg", "mime": "image/jpeg", "width": 245, "height": 138, "size": 6.55, "path": null, "url": "/uploads/thumbnail_image_821354_40137978_3d3405f155.jpg" }, "small": { "name": "small_image_821354_40137978.jpg", "hash": "small_image_821354_40137978_3d3405f155", "ext": ".jpg", "mime": "image/jpeg", "width": 500, "height": 281, "size": 18.84, "path": null, "url": "/uploads/small_image_821354_40137978_3d3405f155.jpg" } }, "hash": "image_821354_40137978_3d3405f155", "ext": ".jpg", "mime": "image/jpeg", "size": 25.17, "url": "/uploads/image_821354_40137978_3d3405f155.jpg", "previewUrl": null, "provider": "oss", "provider_metadata": null, "created_at": "2022-04-13T07:25:33.000Z", "updated_at": "2022-04-13T08:00:09.000Z" } }, { "id": 55, "pubishDate": null, "title": "2021年我国医药外贸成绩如何?", "locale": "zh-CN", "published_at": "2022-04-18T07:33:32.000Z", "created_at": "2022-04-18T07:33:05.000Z", "updated_at": "2022-04-18T07:33:32.000Z", "content": null, "date": "2022-04-18", "test": null, "newsContent": "2021年,新冠肺炎疫情持续,全球经济复苏缓慢,政治经贸摩擦迭起,给国际医药市场合作增加了诸多不确定性。这一年,国务院办公厅印发《关于全面加强药品监管能力建设的实施意见》,对药品监管水平提升提出进一步要求;新修订《医疗器械监督管理条例》开始实施,落实医疗器械注册人制度,进一步保障医疗器械安全有效;国家医保药品目录和基药目录调整、仿制药一致性评价深入推进、带量采购常态化制度化开展及扩容等,使医药企业既感觉到了政策引导的动力,又体会到了监管和市场的压力。面对国内外市场的双重压力,叠加新冠肺炎疫情的刺激,我国医药行业“走出去”成为越来越多企业的必然选择。\n\n**医疗器械出口占据半壁江山**\n\n2021年,医疗器械出口额994亿美元,同比减少24.7%;进口额447亿美元,同比增长8.3%。导致出口急速下降的结构性因素是以口罩、防护服为代表的医用敷料出口下滑较多,出口额仅为175亿美元,同比下降73.9%。主要原因是随着全球对新冠肺炎疫情的常态化应对和医疗器械产能增加,各个国家和地区防疫物资相对充足,对我国产品的依赖程度降低;同时,部分国家和地区防疫政策导向和应对模式发生了变化,不再有恐慌性采购口罩、防护服、呼吸机的情况。其他传统及优势医疗器械出口均恢复增长,一次性耗材、医院诊疗设备、保健康复用品、口腔设备与材料等均实现20%以上的增长,医疗器械出口仍占据我国医药整体出口的半壁江山。\n\n体外诊断产品成为出口增长最为显著的产品类别。在抗疫过程中,我国体外诊断企业积极开拓全球业务,出口呈井喷式增长,与新冠肺炎疫情相关的抗体、抗原、核酸等检测试剂受到全球市场的青睐,检测试剂企业业绩整体向好。2021年诊断试剂出口额130.9亿美元,同比激增157.4%,其中自行检测类试剂产品占比达84%。海外对家庭抗原自测类产品的推广引发检测市场扩容,国内多家企业新冠病毒抗原检测试剂盒先后获得欧美上市资格,有力地刺激了检测试剂的出口。\n\n受疫情防控影响,全球“宅经济”快速发展,“宅经济”伴随习惯的形成进一步推动相关产业加快发展并刺激市场需求提升,家用健康保健产品出口增长持续强劲,2021年我国按摩保健器具出口额达到64.1亿美元,同比增长47.4%,对欧美日韩等发达市场出口增长较快。\n\n我国高端诊疗设备逐渐在国际舞台上站稳脚跟,2021年医院诊断与治疗设备出口额达到329.7亿美元,同比增长21.7%,出口增长的品种包括彩超、X射线断层检查仪、核磁共振成像装置、助听器、人造关节、内窥镜等,但在2020年因抗疫而出口暴增的呼吸机、患者监护仪2021年出口大幅下滑。\n\n**医用耗材已成为我国医疗器械出口中最大的品类,2021年出口额达到357.2亿美元,同比增长28.5%。注射器、管状金属针头、硫化橡胶手套、缝合用针等产品的出口均实现了较大幅度增长,血管支架、骨科等高端产品也在国际市场占据了一席之地。**\n", 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"date": "2022-04-24", "test": null, "newsContent": "苏州融晟医疗科技有限公司(下文简称“融晟医疗”)近日宣布完成数千万元A轮融资,本轮融资由醴泽资本领投,现有股东乔景资本跟投,由点石资本担任独家顾问。本轮融资将用于产品注册申报、市场拓展及管线产品的研发。\n\n融晟医疗成立于2019年,是一家专注肿瘤精准内放射介入治疗领域的平台型公司。公司基于放射粒子内照射支架技术,开发了一系列针对不同适应症的支架产品。目前,公司首款产品胆道粒子支架已获得国家创新医疗器械认证,正在进行NMPA注册申报工作。目前,公司已与包括南微医学、东南大学、至善消融研究院等国内外产业、高校等机构建立深度合作关系。公司已搭建数十人的高素质团队,研发人员均有国内外知名医疗器械公司研发及管理经验。\n", "url": null, "image": { "id": 1049, "name": "50690305_s.jpg", "alternativeText": "", "caption": "", "width": 852, "height": 562, "formats": { "thumbnail": { "name": "thumbnail_50690305_s.jpg", "hash": "thumbnail_50690305_s_cb2a22cec0", "ext": ".jpg", "mime": "image/jpeg", "width": 236, "height": 156, "size": 7.43, "path": null, "url": "/uploads/thumbnail_50690305_s_cb2a22cec0.jpg" }, "medium": { "name": "medium_50690305_s.jpg", "hash": "medium_50690305_s_cb2a22cec0", "ext": ".jpg", "mime": "image/jpeg", "width": 750, "height": 495, "size": 54.95, "path": null, "url": "/uploads/medium_50690305_s_cb2a22cec0.jpg" }, "small": { 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"4月21日,上海微创医疗机器人(集团)股份有限公司(2252.HK)(”微创医疗”)发布公告称,其自主研发的鸿鹄骨科手术机器人获得国家药监局的上市批淮,成为第一款搭载中国企业自主研发机械臂并获淮上市的骨科手术机器人。\n\n鸿鹄由微创医疗自主研发,专为关节置换手术而设计的骨科手术机器人,其辅助下全膝关节置换手术,具有个性精准、高效协同、安全保护和相容性强等众多技术优势。与传统手术相比,鸿鹄术前协助医生制定个性化手术方案,术中辅助操作,降低手术对医生经验的依赖,且术中无髓内杆植入,降低患者的手术损伤,改善术后下肢力线,减少手术并发症,帮助患者实现术后快速康复。\n\n", "url": null, "image": { "id": 1048, "name": "1650583622000134684.jpg", "alternativeText": "", "caption": "", "width": 1400, "height": 570, "formats": { "thumbnail": { "name": "thumbnail_1650583622000134684.jpg", "hash": "thumbnail_1650583622000134684_c40d180f6b", "ext": ".jpg", "mime": "image/jpeg", "width": 245, "height": 100, "size": 7.17, "path": null, "url": "/uploads/thumbnail_1650583622000134684_c40d180f6b.jpg" }, "large": { "name": "large_1650583622000134684.jpg", "hash": "large_1650583622000134684_c40d180f6b", "ext": ".jpg", "mime": "image/jpeg", "width": 1000, "height": 407, "size": 65.88, "path": null, "url": "/uploads/large_1650583622000134684_c40d180f6b.jpg" }, "medium": { "name": 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"2022-04-24T07:36:02.000Z", "content": null, "date": "2022-04-24", "test": null, "newsContent": "4月21日,沃比医疗控股有限公司(\"沃比医疗\")宣布已成功完成收购位于德国的全球神经介入行业创新和技术领先企业phenox GmbH及其旗下femtos GmbH(合称\"phenox\")。本次收购的总对价约为5亿欧元(含里程碑付款),为近年来全球医疗器械行业最大的跨境并购交易之一。据悉,本次收购的资金来源于沃比医疗的D轮融资。\n\n本次收购已获得相关监管批准并交割完成。沃比医疗首席执行官安穆克(Michael Alper)将出任合并后公司的首席执行官。phenox创始人Hermann Monstadt教授、博士将担任phenox董事总经理。phenox旗下现有的所有产品品牌将被保留。\n\nphenox总部位于德国波鸿,专注于为神经血管疾病的治疗提供技术和解决方案,产品销往全球超过45个国家和地区,用于治疗缺血性和出血性脑卒中。两家公司自2019年起成为战略合作伙伴。phenox在美国和欧洲市场独家销售沃比医疗的Avenir机械解脱弹簧圈,同时在美国市场独家销售沃比医疗的Esperance抽吸导管。旗下femtos开发和生产用于治疗中风的新一代神经介入医疗器械,在生产支架和其他可植入设备中用到的飞秒激光技术方面具有独特专长,作为一家创新医疗技术产品的孵化器企业,迄今已开发出两款获欧盟CE认证的产品。\n", "url": null, "image": { "id": 1047, "name": "202202211057266135.jpg", "alternativeText": "", "caption": "", "width": 1600, "height": 667, "formats": { "thumbnail": { "name": "thumbnail_202202211057266135.jpg", "hash": "thumbnail_202202211057266135_f6fad43b75", "ext": ".jpg", "mime": "image/jpeg", "width": 245, "height": 102, "size": 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"近日,国家药品监督管理局经审查,批准了三款创新医疗器械的注册,分别为:苏州天鸿盛捷医疗器械有限公司(天鸿盛捷)的髂静脉支架系统、骨圣元华机器人(深圳)有限公司(骨圣元华)的膝关节置换手术导航定位系统、北京品驰医疗设备有限公司(品驰医疗)的脊髓神经刺激测试电极。\n\n天鸿盛捷的髂静脉支架系统由髂静脉支架和输送系统组成。髂静脉支架由镍钛合金制成;输送系统由输送鞘组件、推杆组件、尖端和手柄等部件组成。该产品在髂总静脉内使用,用于治疗非血栓性髂静脉压迫综合征。该产品的特殊设计可以减少支架对侧髂静脉血液回流的影响,提高支架的定位及释放的准确性,更好解决髂静脉受压问题及增加产品柔顺性。\n\n骨圣元华的膝关节置换手术导航定位系统属于具有自主知识产权的国内首创医疗器械,各项性能指标达到国际同品种器械水平。该产品由机械臂系统、导航仪系统、主控台车系统、手术电动工具组成,可在成人全膝关节置换手术中,用于膝关节假体和手术工具的导航定位。该产品可辅助医生完成手术,导航定位精度满足临床使用要求,能够降低X射线对医生和患者的辐射损伤。\n\n品驰医疗的脊髓神经刺激测试电极与适配的体外测试刺激器、程控仪和多电极测试电缆配合使用,用于评估脊髓神经刺激系统对于躯干、四肢的慢性顽固性疼痛的治疗效果。该产品可以根据患者姿势自动调用预设置的刺激参数,使患者达到当前满意的治疗状态;并支持远程程控功能,提供了一种患者不必到医院就能实现参数调整的方法,可减少患者往返医院的次数。", "url": null, "image": { "id": 1052, "name": "9524788_s.jpg", "alternativeText": "", "caption": "", "width": 793, "height": 604, "formats": { "thumbnail": { "name": "thumbnail_9524788_s.jpg", "hash": "thumbnail_9524788_s_ef73fadd91", "ext": ".jpg", "mime": "image/jpeg", "width": 205, "height": 156, "size": 5.32, "path": null, "url": 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"content": null, "date": "2022-04-28", "test": null, "newsContent": "2022年4月27日,上海心玮医疗科技股份有限公司(心玮医疗,6609.HK)发布公告称,旗下抽吸导管及支撑导管的注册申请已获得中国国家药监局(NMPA)的批准。 \n\n抽吸导管用于抽吸取栓术,为因大血管闭塞引致急性缺血性脑卒中(AIS-LVO)的患者检索血栓并恢复闭塞脑血管的血流。支撑导管为用于神经介入手术的一种血管通路器械;该产品的获批使心玮医疗成为中国首家提供涵盖支架及抽吸取栓术完整国内产品组合的公司。截至公告日期,心玮医疗在神经介入治疗器械市场的四个领域共获得13个NMPA批准的产品。", "url": null, "image": null }, { "id": 64, "pubishDate": null, "title": "谱创医疗完成亿元A轮融资,布局高端有源血管介入治疗", "locale": "zh-CN", "published_at": "2022-05-10T02:22:09.000Z", "created_at": "2022-05-10T02:22:06.000Z", "updated_at": "2022-05-10T02:22:09.000Z", "content": null, "date": "2022-05-10", "test": null, "newsContent": "2022年5月7日,谱创医疗科技(上海)有限公司(以下简称“谱创医疗”)近日完成亿元人民币的A轮融资。本轮融资由君联资本领投,拔萃资本、怀德资本跟投,原股东旸昀资本继续加持。据悉,本轮所筹资金将用于支持公司正在进行的两项冲击波导管产品的临床研究、升级技术创新平台、扩展产品管线,以及产能提升。\n\n谱创医疗成立于2019年3月,总部位于上海,是一家专注于打造高端有源心脏与血管介入技术平台的医疗科技公司。其首个推出的产品是公司自主研发并获得专利授权的血管内冲击波球囊导管系统Sonico。该系统主要针对动脉血管钙化的治疗,能够360度发射冲击波能量,均匀地震裂环形钙化斑块。当前临床数据显示,Sonico系统安全有效,并能简单快捷地解决严重动脉钙化这一血管介入治疗痛点。公司于2021年11月开展了全国首个国产外周血管内冲击波碎石系统的注册临床试验,并在12月启动了冠脉血管内冲击波碎石系统的首例临床入组。", "url": null, "image": { "id": 1063, "name": "9e4f5451d42187acb963f273399a3893.jpeg", "alternativeText": "", "caption": "", "width": 447, "height": 217, "formats": { "thumbnail": { "name": "thumbnail_9e4f5451d42187acb963f273399a3893.jpeg", "hash": "thumbnail_9e4f5451d42187acb963f273399a3893_4408c80588", "ext": ".jpeg", "mime": "image/jpeg", "width": 245, "height": 119, "size": 4.32, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/thumbnail_9e4f5451d42187acb963f273399a3893_4408c80588.jpeg" } }, "hash": 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"2022年5月7日,信立泰药业(002294.SZ)全资子公司信立泰生物医疗宣布已于近日完成了数亿元A轮战略融资,由信达鲲鹏(深圳)股权投资管理有限公司(下称信达鲲鹏)领投,浩悦资本担任独家财务顾问。本轮融资主要用于推进现有心脑血管产品管线临床进展以及补充运营资金。\n\n信立泰生物医疗是信立泰药业旗下打造的心脑血管创新医疗器械平台。公司在神经介入、心血管介入、外周血管、结构性心脏病、电生理、高血压领域陆续通过自研、收购、产品权益引进等方式开发多款全球首创、中国首创的血管植介入器械产品,打造围绕上述心脑血管病种从诊断、预防、治疗到康复的全面解决方案。\n\n公司的核心产品包括神经介入领域的Maurora椎动脉支架是全球首款用于椎动脉狭窄的雷帕霉素载药支架,于2020年底获中国国家药监局批准,并于2021年取得商业化里程碑。心血管介入包括全球领先载药涂层技术的雷帕霉素冠脉药物球囊,目前正处于注册临床阶段,有望成为中国首批雷帕霉素载药球囊的上市产品。结构性心脏病的LAMax LAAC左心耳封堵器是现有国内最早和全球应用最广泛的波士顿科学WATCHMAN开展随机对照试验的左心耳封堵器产品,现已进入注册申报阶段。外周血管方向也布局包括腔静脉滤器、髂静脉支架、下肢药物洗脱支架、雷帕霉素外周药物球囊等多款创新产品。", "url": null, "image": { "id": 1062, "name": "20210719145722945.jpg", "alternativeText": "", "caption": "", "width": 1800, "height": 1067, "formats": { "thumbnail": { "name": "thumbnail_20210719145722945.jpg", "hash": "thumbnail_20210719145722945_bcc7f67bff", "ext": ".jpg", "mime": "image/jpeg", "width": 245, "height": 145, "size": 6.1, "path": null, "url": 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"2022年5月7日,茵络医疗宣布近日将完成过亿元C+轮融资,由创谷资本领投,目前首批资金已到位。\n\n茵络医疗成立于2013年1月,主要布局外周血管、结构性心脏病及通路类高值耗材三大细分领域。其布局产品包括抗疲劳下肢动脉支架系统、髂静脉支架、心脏瓣膜、导引导丝、造影导丝、大血管和介入瓣专用硬导丝、静脉剥脱导管、三叉神经球囊等。截止目前,茵络医疗的抗疲劳支架系统Inno-Spring已获得欧盟CE认证;静脉支架Inno-Xmart已完成临床随访;造影导丝Inno-Hydrowire、导引导丝Inno-Pathwire、超硬导丝Inno-Taviwire、静脉剥脱导管Veno-Bright已获中国国家药监局批准,造影导丝和导引导丝两款产品还获得了美国FDA认证。", "url": null, "image": { "id": 1061, "name": "20190729144142_36852.jpg", "alternativeText": "", "caption": "", "width": 800, "height": 580, "formats": { "thumbnail": { "name": "thumbnail_20190729144142_36852.jpg", "hash": "thumbnail_20190729144142_36852_b893f9b51c", "ext": ".jpg", "mime": "image/jpeg", "width": 215, "height": 156, "size": 4.71, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/thumbnail_20190729144142_36852_b893f9b51c.jpg" }, "medium": { "name": "medium_20190729144142_36852.jpg", "hash": "medium_20190729144142_36852_b893f9b51c", "ext": ".jpg", "mime": "image/jpeg", 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"title": "美敦力经导管植入式无导线起搏系统在华获批", "locale": "zh-CN", "published_at": "2022-05-16T04:02:45.000Z", "created_at": "2022-05-16T04:02:42.000Z", "updated_at": "2022-05-16T04:02:45.000Z", "content": null, "date": "2022-05-16", "test": null, "newsContent": "近日,国家药品监督管理局经审查,批准了美敦力公司(Medtronic Inc.)生产的“经导管植入式无导线起搏系统”创新产品注册申请。该系统采用的无导线起搏器中的机械感知和房室同步起搏技术,在国内外均为首创。\n\n该系统由植入式脉冲发生器(含固定翼)和输送导管组成,可在右心室内感知患者心脏活动,监测心动过缓心律并针对心动过缓提供起搏治疗。该系统为磁共振环境条件安全的医疗器械,在规定的条件及保证对患者和植入设备采取了特殊保护措施的前提下,患者可接受临床1.5T和3.0T场强的磁共振成像检查。\n\n在前代产品的基础上,该系统还增加了机械感知和房室同步起搏技术,实现房室同步起搏,且无需将起搏器电极导线穿过静脉或三尖瓣,使得静脉阻塞的患者也可以植入起搏器。与已有的VVI单心室起搏模式相比,房室同步起搏可以增加心室中的血液量,使得每次心室搏动时的每搏输出量增加,从而带来相应的临床获益。", "url": null, "image": { "id": 1064, "name": "捕获.JPG", "alternativeText": "", "caption": "", "width": 290, "height": 109, "formats": { "thumbnail": { "name": "thumbnail_捕获.JPG", "hash": "thumbnail__d461c2cf5a", "ext": ".JPG", "mime": "image/jpeg", "width": 245, "height": 92, "size": 3.38, "path": null, "url": 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"活动名称:临港浦江“企业之家”助企复工复产系列活动\n主办方:上海临港浦江国际科技城\n活动时间:5月-6月(我们的直播时间5月23日 14:00-15:30)\n活动介绍:\n当前,上海市正分批有序推进企业复工复产。为帮助企业提前做好复工复产准备,打通因疫情造成的供应链堵点,促进产业链上下游企业交流衔接,临港浦江园区拟于近期推出临港浦江“企业之家”助企复工复产主题系列线上活动,组织从事研发设计服务、制造加工服务、产品配套服务等企业,开展同领域上下游企业技术分享、产品服务交流与对接活动。\n\n2022年5月23号的浦江临港科技城Webnair,药明康德中国医疗器械测试中心将有两位讲者分享,内容如下:\n\n题目:《医疗器械局部组织反应的生物相容性试验 – 植入、血栓形成、特殊刺激》\n讲者:Peter Chen\n\t医疗器械植入试验的设计\n\t体内血栓形成试验的基本思路\n\tNAVI模型的挑战及注意事项\n\t体内特殊刺激试验的测试方法\n\n题目:《基于生物学风险分析的医疗器械生物学评价在高风险医疗器械产品中的应用》\n讲者:许雪萍\n随着ISO 10993-1:2018版的发布及国标GB/T 16886.1《医疗器械生物学评价第1部分:风险管理过程中的评价与试验》等同转化工作的启动,监管机构对于医疗器械可沥滤物的毒理学风险评估更加关注。结合化学表征和毒理学风险评估的信息评价产品的系统毒性(急性毒性、亚慢性毒性和慢性毒性等)、遗传毒性、生殖/发育毒性和致癌性在内的生物学终点,优化生物学评价方案,最终达到产品安全性评价的目的。本次演讲基于ISO 10993-1:2018,并通过具体实例进一步分享高风险医疗器械生物学评价过程中的评估和测试思路。", "url": null, "image": { "id": 1076, "name": "0518_.jpg", "alternativeText": "", "caption": "", "width": 700, "height": 1065, "formats": { "thumbnail": { "name": "thumbnail_0518_.jpg", "hash": "thumbnail_0518_685668cb30", "ext": ".jpg", "mime": "image/jpeg", "width": 103, "height": 156, "size": 4.61, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/thumbnail_0518_685668cb30.jpg" }, "large": { "name": "large_0518_.jpg", "hash": "large_0518_685668cb30", "ext": ".jpg", "mime": "image/jpeg", "width": 657, "height": 1000, "size": 85.21, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/large_0518_685668cb30.jpg" }, "medium": { "name": "medium_0518_.jpg", "hash": "medium_0518_685668cb30", "ext": ".jpg", "mime": "image/jpeg", "width": 493, "height": 750, "size": 55.26, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/medium_0518_685668cb30.jpg" }, "small": { "name": "small_0518_.jpg", "hash": "small_0518_685668cb30", "ext": ".jpg", "mime": "image/jpeg", "width": 329, "height": 500, "size": 30.46, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/small_0518_685668cb30.jpg" } }, "hash": "0518_685668cb30", "ext": ".jpg", "mime": "image/jpeg", "size": 90.3, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/0518_685668cb30.jpg", "previewUrl": null, "provider": "oss", "provider_metadata": null, "created_at": "2022-05-18T08:30:06.000Z", "updated_at": "2022-05-18T08:30:06.000Z" } }, { "id": 68, "pubishDate": null, "title": "华匠医学机器人获数千万人民币A轮融资", "locale": "zh-CN", "published_at": "2022-05-18T02:01:45.000Z", "created_at": "2022-05-18T01:58:30.000Z", "updated_at": "2022-05-18T02:01:45.000Z", "content": null, "date": "2022-05-17", "test": null, "newsContent": "微创手术机器人创新企业杭州华匠医学机器人有限公司(以下简称“华匠医学机器人”)完成数千万人民币A轮融资,本轮融资由普华资本和东方嘉富联合领投,西湖科创投参与跟投。本轮融资旨在加速推动相关核心产品的研发、临床和商业化进展。\n\n华匠医学机器人成立于2020年7月,目前已完成可弯器械、持械机械人和手术机器人三大产品体系的搭建,其中多款产品进入注检/临床/取证阶段。同时,公司目前已申报30项专利,其中12项专利已授权。", "url": null, "image": { "id": 1068, "name": "792b6954f49147929b6ecb4c8076c17e.jpeg", "alternativeText": "", "caption": "", "width": 618, "height": 549, "formats": { "thumbnail": { "name": "thumbnail_792b6954f49147929b6ecb4c8076c17e.jpeg", "hash": "thumbnail_792b6954f49147929b6ecb4c8076c17e_7f0e93a8c1", "ext": ".jpeg", "mime": "image/jpeg", "width": 176, "height": 156, "size": 6.95, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/thumbnail_792b6954f49147929b6ecb4c8076c17e_7f0e93a8c1.jpeg" }, "small": { "name": "small_792b6954f49147929b6ecb4c8076c17e.jpeg", "hash": "small_792b6954f49147929b6ecb4c8076c17e_7f0e93a8c1", "ext": ".jpeg", "mime": "image/jpeg", "width": 500, "height": 444, "size": 37.37, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/small_792b6954f49147929b6ecb4c8076c17e_7f0e93a8c1.jpeg" } }, "hash": "792b6954f49147929b6ecb4c8076c17e_7f0e93a8c1", "ext": ".jpeg", "mime": "image/jpeg", "size": 44.98, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/792b6954f49147929b6ecb4c8076c17e_7f0e93a8c1.jpeg", "previewUrl": null, "provider": "oss", "provider_metadata": null, "created_at": "2022-05-18T01:58:24.000Z", "updated_at": "2022-05-18T01:58:24.000Z" } }, { "id": 69, "pubishDate": null, "title": "MDR要求下的CE技术文件", "locale": "zh-CN", "published_at": "2022-05-18T02:05:32.000Z", "created_at": "2022-05-18T02:04:11.000Z", "updated_at": "2022-05-18T02:10:51.000Z", "content": null, "date": "2022-05-18", "test": null, "newsContent": "欧盟Medical Device Regulation 2017/745(下称:MDR)从2021年5月26日强制执行,也就意味着欧盟正式进入了MDR时期。企业在准备MDR下CE认证申请的过程中,技术文件是避不开的话题,那么今天就浅谈一下技术文件在准备过程中的一些注意事项。", "url": "https://mp.weixin.qq.com/s/euQ8DeRbSotN2KSBpxy40A", "image": { "id": 1069, "name": "640.jfif", "alternativeText": "", "caption": "", "width": 1080, "height": 618, "formats": { "thumbnail": { "name": "thumbnail_640.jfif", "hash": "thumbnail_640_907431ae4b", "ext": ".jfif", "mime": "image/jpeg", "width": 245, "height": 140, "size": 8.74, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/thumbnail_640_907431ae4b.jfif" }, "large": { "name": "large_640.jfif", "hash": "large_640_907431ae4b", "ext": ".jfif", "mime": "image/jpeg", "width": 1000, "height": 572, "size": 65.53, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/large_640_907431ae4b.jfif" }, "medium": { "name": "medium_640.jfif", "hash": "medium_640_907431ae4b", "ext": ".jfif", "mime": "image/jpeg", "width": 750, "height": 429, "size": 45.17, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/medium_640_907431ae4b.jfif" }, "small": { "name": "small_640.jfif", "hash": "small_640_907431ae4b", "ext": ".jfif", "mime": "image/jpeg", "width": 500, "height": 286, "size": 24.82, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/small_640_907431ae4b.jfif" } }, "hash": "640_907431ae4b", "ext": ".jfif", "mime": "image/jpeg", "size": 71.99, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/640_907431ae4b.jfif", "previewUrl": null, "provider": "oss", "provider_metadata": null, "created_at": "2022-05-18T02:10:42.000Z", "updated_at": "2022-05-18T02:10:42.000Z" } }, { "id": 70, "pubishDate": null, "title": "医疗器械免疫毒性试验", "locale": "zh-CN", "published_at": "2022-05-18T02:16:58.000Z", "created_at": "2022-05-18T02:16:55.000Z", "updated_at": "2022-05-18T02:16:58.000Z", "content": null, "date": "2022-05-13", "test": null, "newsContent": "免疫的定义是维持机体免疫罹患感染性疾病的稳态环境。是一系列精密平衡的、复杂的、多细胞的生理学机制,使个体从”自我”中区分外来物,并中和/或清除外来物。\n\n根据免疫系统在维持机体健康中产生的重要作用,研究外源物质(药物,医疗器械)与免疫系统各种组成部分的相互作用已经成为非常重要的领域。", "url": "https://mp.weixin.qq.com/s/3L7_YPC1YQpstlBB_GCupw", "image": { "id": 1070, "name": "640 (1).jfif", "alternativeText": "", "caption": "", "width": 640, "height": 426, "formats": { "thumbnail": { "name": "thumbnail_640 (1).jfif", "hash": "thumbnail_640_1_f656d96b7a", "ext": ".jfif", "mime": "image/jpeg", "width": 234, "height": 156, "size": 6.59, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/thumbnail_640_1_f656d96b7a.jfif" }, "small": { "name": "small_640 (1).jfif", "hash": "small_640_1_f656d96b7a", "ext": ".jfif", "mime": "image/jpeg", "width": 500, "height": 333, "size": 19.97, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/small_640_1_f656d96b7a.jfif" } }, "hash": "640_1_f656d96b7a", "ext": ".jfif", "mime": "image/jpeg", "size": 29.16, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/640_1_f656d96b7a.jfif", "previewUrl": null, "provider": "oss", "provider_metadata": null, "created_at": "2022-05-18T02:16:50.000Z", "updated_at": "2022-05-18T02:16:50.000Z" } }, { "id": 71, "pubishDate": null, "title": "案例 | MD医疗器械生物学评价,助力客户成功获取CE认证", "locale": "zh-CN", "published_at": "2022-05-18T02:28:47.000Z", "created_at": "2022-05-18T02:28:43.000Z", "updated_at": "2022-05-18T02:28:47.000Z", "content": null, "date": "2022-03-04", "test": null, "newsContent": "对于直接或间接接触人体的医疗器械,良好的生物相容性是其临床安全有效应用的前提条件。ISO 10993-1:2018[2]、FDA于2020年发布的关于如何使用ISO 10993的指导原则[1]、以及GB/T 16886.1征求意见稿(2020)[4]均从风险管理的角度为医疗器械的生物学评价提供了一个框架。", "url": "https://mp.weixin.qq.com/s/ECsxsps_Nr1_HVIHTj1-7g", "image": { "id": 1071, "name": "640.png", "alternativeText": "", "caption": "", "width": 955, "height": 405, "formats": { "thumbnail": { "name": "thumbnail_640.png", "hash": "thumbnail_640_b3f11422f3", "ext": ".png", "mime": "image/png", "width": 245, "height": 104, "size": 5.23, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/thumbnail_640_b3f11422f3.png" }, "medium": { "name": "medium_640.png", "hash": "medium_640_b3f11422f3", "ext": ".png", "mime": "image/png", "width": 750, "height": 318, "size": 33.75, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/medium_640_b3f11422f3.png" }, "small": { "name": "small_640.png", "hash": "small_640_b3f11422f3", "ext": ".png", "mime": "image/png", "width": 500, "height": 212, "size": 16.69, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/small_640_b3f11422f3.png" } }, "hash": "640_b3f11422f3", "ext": ".png", "mime": "image/png", "size": 34.63, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/640_b3f11422f3.png", "previewUrl": null, "provider": "oss", "provider_metadata": null, "created_at": "2022-05-18T02:28:39.000Z", "updated_at": "2022-05-18T02:28:39.000Z" } }, { "id": 72, "pubishDate": null, "title": "【直播预告】MD云课堂—生物学材料类产品的生物学评价对于注册申报的重要性", "locale": "zh-CN", "published_at": "2022-05-19T08:31:00.000Z", "created_at": "2022-05-19T08:30:57.000Z", "updated_at": "2022-05-20T05:09:09.000Z", "content": null, "date": "2022-05-19", "test": null, "newsContent": "生物学材料类产品的生物学评价对于注册申报的重要性", "url": "https://mp.weixin.qq.com/s/NPfdqVpwz-23leO3hUkE9A", "image": { "id": 1088, "name": "640 (2).jfif", "alternativeText": "", "caption": "", "width": 1080, "height": 386, "formats": { "thumbnail": { "name": "thumbnail_640 (2).jfif", "hash": "thumbnail_640_2_c1d20ec722", "ext": ".jfif", "mime": "image/jpeg", "width": 245, "height": 88, "size": 5.85, "path": null, "url": 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"2022年5月20日,上海百心安生物技术股份有限公司(百心安,2185.HK)发布公告称,其已与临床试验研究员确定临床研究计划,确定将在欧洲心血管研究中心(CERC)进行RADIUS-HTN试验,评估百心安旗下第二代Iberis肾神经阻断(RDN)系统治疗未控高血压患者,比较通过经桡动脉入路(TRA)和经动脉入路(TFA)进行肾神经阻断的疗效。\n\n公告称,百心安是全球唯一一家拥有CE标志可就TRA及TFA使用导管治疗高血压的公司。医生及患者偏好使用TRA法进行血管介入治疗。与TFA相比,TRA介入治疗可减少侵入身体部位的并发症及缩短住院时间,同时降低手术成本及提高患者满意度。第二代Iberis系统是一种通过装置进行用于治疗高血压的低侵入性手术。2022年1月26日,第二代Iberis临床试验在中国的患者入组工作完成。\n\n", "url": null, "image": { "id": 1094, "name": "捕获.GIF", "alternativeText": "", "caption": "", "width": 953, "height": 483, "formats": null, "hash": "_9757e57122", "ext": ".GIF", "mime": "image/gif", "size": 118.01, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/_9757e57122.GIF", "previewUrl": null, "provider": "oss", "provider_metadata": null, "created_at": "2022-05-23T01:25:39.000Z", "updated_at": "2022-05-23T01:25:40.000Z" } }, { "id": 75, "pubishDate": null, "title": "健适医疗Shockwave血管内冲击波系列产品国内获批上市", "locale": "zh-CN", "published_at": 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"5月24日,国家药品监督管理局官网公示,杭州唯强医疗科技有限公司生产的创新产品“胸主动脉支架系统”注册获批。\n\n该产品由近端胸主动脉覆膜支架系统和远端胸主动脉裸支架系统组成。近端胸主动脉覆膜支架系统封堵B型夹层近端破口,促使假腔内血栓化;远端胸主动脉裸支架系统扩张降主动脉远端真腔,促进主动脉真腔重塑。其中支架的结构设计使其具有良好的柔顺性及一定的径向和轴向支撑力。胸主动脉覆膜支架和胸主动脉裸支架分别预装在对应的输送器中,输送器的设计可保证释放过程的稳定性及支架精准定位。\n主动脉夹层起病急,进展快,病死率高,支架类产品已成为腔内介入治疗该类疾病的主要手段。该产品适用于治疗Stanford B型夹层,支架近端锚定区长度≥15mm,且病变符合以下条件之一:1.存在远端破口,有处理远端病变的必要性;2.夹层累及范围较广,且存在远端真腔塌陷;3.夹层伴远端灌注不良。该产品的上市将为患者带来新的治疗选择。", "url": null, "image": { "id": 1103, "name": "T6q2OT9C8EvhTH.png", "alternativeText": "", "caption": "", "width": 900, "height": 310, "formats": { "thumbnail": { "name": "thumbnail_T6q2OT9C8EvhTH.png", "hash": "thumbnail_T6q2_OT_9_C8_Evh_TH_f9ffdb26bb", "ext": ".png", "mime": "image/png", "width": 245, "height": 84, "size": 9.55, "path": null, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/thumbnail_T6q2_OT_9_C8_Evh_TH_f9ffdb26bb.png" }, "medium": { "name": "medium_T6q2OT9C8EvhTH.png", "hash": 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"zh-CN", "published_at": "2022-05-30T02:41:58.000Z", "created_at": "2022-05-30T02:41:55.000Z", "updated_at": "2022-05-30T02:41:58.000Z", "content": null, "date": "2022-05-27", "test": null, "newsContent": "2022年5月26日,上海微创医疗机器人(集团)股份有限公司(2252.HK)发布公告称,本公司和法国Robocath S.A.S联合在华成立的合资公司知脉(上海)机器人有限公司引进的R-ONE血管介入手术机器人(R-ONE)已完成注册临床试验入组,成为国内首款完成多中心注册临床试验入组的心血管介入机器人系统。\n\n本次注册临床试验由301医院牵头,山西省心血管病医院、梅州市人民医院及新疆维吾尔自治区人民医院共同参与。于临床试验期间,R-ONE完成了双支病变、同轴性差的大角度扭曲血管病变、弥漫长病变、钙化性病变、开口异位以及次全闭塞等多种疑难复杂病例,并多次完成三连台手术,充分验证了R-ONE的稳定性和可靠性。\n\nR-ONE是基于主从控制技术的血管介入导航控制系统,通过多项核心专利,辅助医生更加精准、高效、可靠的完成PCI手术,且学习曲线短,同时可减少手术并发症。此外,使用R-ONE时,术者可坐在防辐射控制台后,通过远程操控,在完成精确手术操作的同时有效减少了在射线下的暴露时间。", "url": null, "image": { "id": 1113, "name": "捕获.GIF", "alternativeText": "", "caption": "", "width": 1137, "height": 594, "formats": null, "hash": "_3768080378", "ext": ".GIF", "mime": "image/gif", "size": 110.14, "url": "https://md.wuxiapptec.com/api/uploads/https://wuxiapptech-ltdmd.oss-cn-shanghai.aliyuncs.com/mdvideo/_3768080378.GIF", 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