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夜雨聆风 > > 办公文件 > 环予医疗助力楚精灵获批国内首个胃癌AI软件三类注册证

环予医疗助力楚精灵获批国内首个胃癌AI软件三类注册证

当前时间： 2026-04-09 02:07:40 分类：办公文件 评论(0)
环予医疗助力楚精灵获批国内首个胃癌AI软件三类注册证

近期，国家药品监督管理局（NMPA）正式批准武汉楚精灵医疗科技公司胃部病变电子内窥镜图像辅助分诊软件，用于诊断胃部病变中高级别上皮内瘤变及以上病变的图像特征。

这是国内首个聚焦胃癌领域的 AI 辅助诊断三类医疗器械认证，也是楚精灵继 2023 年获批下消化道 AI 三类医疗器械注册证后的又一重大突破。此次获批，标志着楚精灵成为全国首个上、下消化道 AI 产品均获得国家三类认证的企业。

环予医疗作为该项目的CRO，为楚精灵提供了从型式检验、临床试验到注册申报的全流程医疗器械合规咨询服务，包含医疗器械产品从定型之后到注册拿证全生命周期，高效合规协助客户完成了国家局注册。

      上海环予医疗成立于2016年，为医疗器械制造商提供医疗器械合规咨询服务。服务包括型式检验、质量体系、临床试验/研究、同品种临床评价、创新申报、NMPA注册、CE认证、FDA认证等。

      我们擅长创新医疗器械产品申报，尤其是人工智能及有源器械类。

公司总部：上海市杨浦区荆州路198号万硕大厦2005单元
北京分公司：北京朝阳区大洋路8号东方文创大厦4层411室
邮箱：info@huanyu-medical.com
网址：www.huanyu-medical.com
座机：021-62160330

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  1. CONNECT:[ UseTime:0.000751s ] mysql:host=127.0.0.1;port=3306;dbname=wenku;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001320s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000545s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.017447s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001285s ]
  6. SELECT * FROM `set` [ RunTime:0.008462s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001360s ]
  8. SELECT * FROM `article` WHERE `id` = 503522 LIMIT 1 [ RunTime:0.000822s ]
  9. UPDATE `article` SET `lasttime` = 1775789362 WHERE `id` = 503522 [ RunTime:0.014093s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 64 LIMIT 1 [ RunTime:0.002800s ]
  11. SELECT * FROM `article` WHERE `id` < 503522 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.002121s ]
  12. SELECT * FROM `article` WHERE `id` > 503522 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.006452s ]
  13. SELECT * FROM `article` WHERE `id` < 503522 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.001574s ]
  14. SELECT * FROM `article` WHERE `id` < 503522 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.002194s ]
  15. SELECT * FROM `article` WHERE `id` < 503522 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.002009s ]
0.153172s