医疗器械
Search documents
微创心通-B:植入式心律转复除颤器进入创新医疗器械特别审查程序
Zhi Tong Cai Jing· 2026-02-13 15:12
微创心通-B(02160)发布公告,近日,国家药品监督管理局"NMPA"医疗器械技术审评中心发布《创新医 疗(002173)器械特别审查申请审查结果公示(2026年第3号)》,拟同意集团旗下新一代植入式心律转 复除颤器(ICD)TILEN/EYLEN(泰然╱怡然)进入创新医疗器械特别审查程序(NMPA绿色通道)。据此, TILEN/EYLEN(泰然╱怡然)有望成为国内首款获批的具备自主知识产权的磁共振条件安全ICD。 TILEN/EYLEN(泰然╱怡然)作为国家科技部立项的国家重点研发计划项目核心产品,旨在填补国内技 术空白,其主要技术优势包括: 自动MRI功能:显著降低非同步模式导致的患者不适,并简化MRI扫描流程; 远程随访:基于低功耗蓝牙技术,依托国内数据中心,构建完整解决方案,增强患者随访依从性; 行业领先的使用寿命:有效减少因设备更换引发的感染风险,降低患者长期经济负担。 心源性猝死(SCD),是指急性心脏相关症状发作后1小时内发生的以意识突然丧失为特征的、由心脏原 因引起的自然死亡,是全球主要的死亡原因之一,而多项大型临床试验证据已经充分证实ICD是目前预 防SCD最为有效的措施,能在患者发生危及 ...
微创心通-B(02160):植入式心律转复除颤器进入创新医疗器械特别审查程序
智通财经网· 2026-02-13 15:10
远程随访:基于低功耗蓝牙技术,依托国内数据中心,构建完整解决方案,增强患者随访依从性; 行业领先的使用寿命:有效减少因设备更换引发的感染风险,降低患者长期经济负担。 智通财经APP讯,微创心通-B(02160)发布公告,近日,国家药品监督管理局"NMPA"医疗器械技术审评 中心发布《创新医疗器械特别审查申请审查结果公示(2026年第3 号)》,拟同意集团旗下新一代植入式 心律转复除颤器(ICD)TILEN/EYLEN (泰然╱怡然)进入创新医疗器械特别审查程序(NMPA绿色通道)。 据此 ,TILEN/EYLEN(泰然╱怡然)有望成为国内首款获批的具备自主知识产权的磁共振条件安全 ICD。 TILEN/EYLEN(泰然╱怡然)作为国家科技部立项的国家重点研发计划项目核心产品,旨在填补国内技 术空白,其主要技术优势包括: 自动MRI功能:显著降低非同步模式导致的患者不适,并简化MRI扫描流程; 心源性猝死(SCD),是指急性心脏相关症状发作后1小时内发生的以意识突然丧失为特征的、由心脏原 因引起的自然死亡,是全球主要的死亡原因之一,而多项大型临床试验证据已经充分证实ICD是目前预 防SCD最为有效的措施,能在患 ...
心通医疗-B(02160.HK):植入式心律转复除颤器进入创新医疗器械特别审查程序
Ge Long Hui· 2026-02-13 15:02
格隆汇2月13日丨心通医疗-B(02160.HK)公告,近日,国家药品监督管理局"NMPA"医疗器械技术审评中 心发布《创新医疗器械特别审查申请审查结果公示(2026年第3号)》,拟同意集团旗下新一代植入式心 律转复除颤器("ICD")TILEN/EYLEN(泰然╱怡然)进入创新医疗器械特别审查程序。据此, TILEN/EYLEN(泰然╱怡然)有望成为国内首款获批的具备自主知识产权的磁共振条件安全ICD。 自动MRI功能:显著降低非同步模式导致的患者不适,并简化MRI扫描流程;远程随访:基于低功耗蓝 牙技术,依托国内数据中心,构建完整解决方案,增强患者随访依从性;行业领先的使用寿命:有效减 少因设备更换引发的感染风险,降低患者长期经济负担。 心源性猝死("SCD"),是指急性心脏相关症状发作后1小时内发生的以意识突然丧失为特征的、由心脏原 因引起的自然死亡,是全球主要的死亡原因之一,而多项大型临床试验证据已经充分证实ICD是目前预 防SCD最为有效的措施,能在患者发生危及生命的恶性室性心律失常(如室颤或室速)时,通过分层治 疗,包括高压除颤,使心律恢复正常。本集团旗下的PLATINIUM系列ICD产品已于20 ...
微创心通-B(02160) - 自愿公告 - 植入式心律转復除颤器进入创新医疗器械特别审查程序
2026-02-13 14:56
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或 因依賴該等內容而引致的任何損失承擔任何責任。 MicroPort CardioFlow Medtech Corporation 微創心通醫療科技有限公司 ( 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ) (股份代號:2160) 自願公告 — 植入式心律轉復除顫器進入 創新醫療器械特別審查程序 本公告乃由微創心通醫療科技有限公司(「本公司」,連同其附屬公司統稱「本 集團」)自願作出,以知會本公司股東及潛在投資者有關本集團最新業務和新 產品開發進展。 本公司董事會(「董事會」)欣然宣佈,近日,國家藥品監督管理局「NMPA」醫療 器械技術審評中心發佈《創新醫療器械特別審查申請審查結果公示(2026年第3 號)》,擬同意本集團旗下新一代植入式心律轉復除顫器(「ICD」)TILEN/EYLEN (泰然╱怡然)進入創新醫療器械特別審查程序(「NMPA綠色通道」)。據此, TILEN/EYLEN(泰然╱怡然)有望成為國內首款獲批的具備自主知識產權的 ...
微创机器人-B:联交所就公司H股全流通授出上市批准
Zhi Tong Cai Jing· 2026-02-13 13:43
Group 1 - The company MicroPort Scientific Corporation (02252) has received approval from the Hong Kong Stock Exchange for the listing and trading of 5.9898 million H shares, which are to be converted and listed [1] - The conversion and listing will involve a total of 5.9898 million non-listed shares held by two shareholders, representing approximately 0.5808% of the total issued shares of the company as of the announcement date [1]
拜尔德医疗股价创历史新低,年初至今累计跌幅超40%
Jing Ji Guan Cha Wang· 2026-02-13 13:26
以上内容基于公开资料整理,不构成投资建议。 经济观察网拜尔德医疗(BDMD.OQ)近7天(2026年2月7日至2月13日)股价呈现显著下跌趋势,引发市场 关注。根据内部数据库及公开信息,关键行情如下:2026年2月12日:收盘价0.80美元,单日下跌 4.76%,盘中最低触及0.77美元,创历史新低,振幅达12.47%,成交额仅8.52万美元,换手率0.28%。年 初至今累计跌幅扩大至41.17%。2026年2月11日:收盘价0.84美元,单日下跌7.59%,开盘价0.95美元, 最低下探至0.80美元,振幅16.51%,成交额20.06万美元。经济观察网报道指出,当日股价下跌8.69%(以 0.83美元收盘),公司未发布重大利空公告,但市盈率(TTM)为负值(-7.55),反映持续亏损状态,且流动 性较低(成交额约17.95万美元),少量卖单易引发大幅波动。2026年2月10日:收盘价0.91美元,单日下 跌10.00%,成交额14.90万美元。2026年2月9日:收盘价1.01美元,单日上涨9.78%,成交额11.72万美 元,为近期唯一上涨日。近7天(以有数据交易日计)股价区间跌幅为13.04%(从2月 ...
股票行情快报:开立医疗(300633)2月13日主力资金净卖出224.51万元
Sou Hu Cai Jing· 2026-02-13 13:05
Core Viewpoint - The stock of Kaili Medical (300633) has shown a decline in price and mixed capital flow, indicating potential volatility in investor sentiment and market performance [1][2]. Group 1: Stock Performance - As of February 13, 2026, Kaili Medical's stock closed at 26.6 yuan, down 1.04% with a turnover rate of 0.48% and a trading volume of 20,900 lots, amounting to a transaction value of 56.07 million yuan [1]. - Over the past five days, the stock has experienced fluctuations, with a notable drop on February 13, where the main capital saw a net outflow of 224.51 million yuan, accounting for 4.0% of the total transaction value [2]. Group 2: Financial Metrics - Kaili Medical's total market capitalization is 11.51 billion yuan, slightly above the industry average of 10.91 billion yuan, ranking 30th out of 129 companies in the medical device sector [3]. - The company reported a net profit of 33.51 million yuan, which is significantly lower than the industry average net profit of 208 million yuan, placing it 79th in the industry ranking [3]. - The company's gross margin stands at 60.36%, which is higher than the industry average of 51.01%, indicating a strong pricing power in its products [3]. Group 3: Recent Financial Performance - For the first three quarters of 2025, Kaili Medical's main revenue reached 1.459 billion yuan, reflecting a year-on-year increase of 4.37%, while the net profit decreased by 69.25% to 33.51 million yuan [3]. - In the third quarter of 2025, the company achieved a quarterly revenue of 495 million yuan, up 28.42% year-on-year, but reported a negative net profit of -13.52 million yuan, despite a year-on-year increase of 78.05% [3]. Group 4: Analyst Ratings - In the last 90 days, four institutions have provided ratings for Kaili Medical, with three giving a "buy" rating and one an "accumulate" rating, indicating a generally positive outlook from analysts [4].
股票行情快报:英科医疗(300677)2月13日主力资金净卖出93.80万元
Sou Hu Cai Jing· 2026-02-13 12:54
Core Viewpoint - The stock of Yingke Medical (300677) has shown a decline in price and mixed financial performance, with a notable increase in net profit but a decrease in revenue in the latest quarter [1][2]. Financial Performance - For the first three quarters of 2025, the company reported a main revenue of 7.425 billion yuan, an increase of 4.6% year-on-year [2]. - The net profit attributable to shareholders reached 924 million yuan, reflecting a significant increase of 34.47% year-on-year [2]. - The net profit excluding non-recurring items was 484 million yuan, which represents a decline of 19.32% year-on-year [2]. - In Q3 2025, the company recorded a single-quarter main revenue of 2.511 billion yuan, down 2.9% year-on-year [2]. - The single-quarter net profit attributable to shareholders was 214 million yuan, showing a remarkable increase of 113.04% year-on-year [2]. - The single-quarter net profit excluding non-recurring items was 84.28 million yuan, down 25.87% year-on-year [2]. - The company's debt ratio stands at 53.79%, with investment income of 183 million yuan and financial expenses of 127 million yuan [2]. - The gross profit margin is reported at 23.7% [2]. Stock Performance and Market Sentiment - As of February 13, 2026, the stock closed at 39.35 yuan, down 1.82%, with a turnover rate of 1.07% and a trading volume of 49,900 hands, amounting to a transaction value of 198 million yuan [1]. - The net outflow of main funds was 938,000 yuan, accounting for 0.47% of the total transaction value, while retail investors saw a net inflow of 2.7368 million yuan, representing 1.38% of the total transaction value [1]. - Over the last 90 days, four institutions have given buy ratings for the stock [3].
摩根大通增持微创医疗(00853)约89.17万股 每股作价约11.09港元
智通财经网· 2026-02-13 12:47
智通财经APP获悉,香港联交所最新数据显示,2月9日,摩根大通增持微创医疗(00853)89.1713万股, 每股作价11.089港元,总金额约为988.82万港元。增持后最新持股数目约为1.92亿股,持股比例为 10.02%。 ...
摩根大通增持微创医疗约89.17万股 每股作价约11.09港元
Zhi Tong Cai Jing· 2026-02-13 12:46
香港联交所最新数据显示,2月9日,摩根大通增持微创医疗(00853)89.1713万股,每股作价11.089港 元,总金额约为988.82万港元。增持后最新持股数目约为1.92亿股,持股比例为10.02%。 ...