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EBR SYSTEMS INC-CDI

0.140

-0.095-40.43%

成交量：2,791.52万

成交额：429.62万

市值：1.18亿

市盈率：-0.74

高：0.220

开：0.220

低：0.130

收：0.235

52周最高：1.470

52周最低：0.130

股本：8.45亿

流通股本：3,748.74万

量比：23.08

换手率：74.47%

股息：- -

股息率：- -

每股收益(TTM):-0.189

每股收益(LYR):-0.168

净资产收益率：-102.51%

总资产收益率：-28.46%

市净率：1.20

市盈率(LYR):-0.83

数据加载中...

总览公司新闻资讯公告

EBR Systems 预计2026年第三季度营收240万至250万美元

EBR Systems宣布计划于2026年第四季度向FDA提交变更生效（CBE）上市前批准（PMA）补充申请

EBR Systems Inc：网络猜测源于涉事站点的强制事件报告，并非美国FDA审查

EBR Systems Inc称现阶段无持续担忧，其他站点商业植入正常进行

EBR Systems Inc 事件：FDA将依据现场信息与公司内部调查结果进行审查

EBR Systems Inc 完成内部调查：一处临床点两名患者出现严重并发症

EBR Systems：两名患者术后出现室颤，一人在术后超声心动图检查中死亡

EBR Systems Inc内部评估：此事件为独立事件，与已披露风险相关

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Systems 预计2026年第三季度营收240万至250万美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1103296586","media":"投资观察","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1103296586?lang=zh_cn&edition=fundamental","pubTime":"2026-10-12 06:17","pubTimestamp":1791757041,"startTime":"0","endTime":"0","summary":"EBR Systems Inc 依据初步未经审计业绩，预计2026年第三季度营收将在243万至253万美元之间。更多公司动态，请关注 EBR.AX。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1187340625","title":"EBR Systems宣布计划于2026年第四季度向FDA提交变更生效（CBE）上市前批准（PMA）补充申请","url":"https://stock-news.laohu8.com/highlight/detail?id=1187340625","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1187340625?lang=zh_cn&edition=fundamental","pubTime":"2026-09-16 06:38","pubTimestamp":1789511893,"startTime":"0","endTime":"0","summary":"EBR Systems近日披露，该公司已规划好下一步监管路径——计划在2026年第四季度向美国食品药品监督管理局（FDA）递交一份变更生效（CBE）上市前批准（PMA）补充申请。这一举措标志着公司在推进其产品审批流程方面迈出了关键一步。值得注意的是，CBE补充申请通常用于在已批准产品的制造、标签或规格等方面实施某些变更，而无需事先获得FDA的明确批准即可生效，但须符合特定条件。EBR Systems此番动作，显然意在加快相关调整的实施节奏，以更好地顺应市场或生产需求的变化。该计划若如期落地，将进一步考验公司在合规框架下的执行效率与应变能力。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1114786525","title":"EBR Systems Inc：网络猜测源于涉事站点的强制事件报告，并非美国FDA审查","url":"https://stock-news.laohu8.com/highlight/detail?id=1114786525","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1114786525?lang=zh_cn&edition=fundamental","pubTime":"2026-07-31 07:13","pubTimestamp":1785453206,"startTime":"0","endTime":"0","summary":"EBR Systems Inc 指出，近日网络上的种种猜测，实则是基于一家涉事站点所提交的强制性事件报告。这一报告，并非美国食品药品监督管理局（FDA）进行的正式审查。公司明确表示，流传的揣测与事实存在偏差，请投资者注意甄别信息源。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1167781876","title":"EBR Systems Inc称现阶段无持续担忧，其他站点商业植入正常进行","url":"https://stock-news.laohu8.com/highlight/detail?id=1167781876","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1167781876?lang=zh_cn&edition=fundamental","pubTime":"2026-07-31 07:13","pubTimestamp":1785453203,"startTime":"0","endTime":"0","summary":"EBR Systems Inc声明，现阶段并不存在持续性的担忧。在其他站点，商业植入工作正按常规流程持续推进。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1146596439","title":"EBR Systems Inc 事件：FDA将依据现场信息与公司内部调查结果进行审查","url":"https://stock-news.laohu8.com/highlight/detail?id=1146596439","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1146596439?lang=zh_cn&edition=fundamental","pubTime":"2026-07-31 07:13","pubTimestamp":1785453189,"startTime":"0","endTime":"0","summary":"EBR Systems Inc 宣布，美国食品药品监督管理局（FDA）将审阅相关事件。此次审查将基于两个关键信息来源：由现场提供的数据，以及该公司刚刚结束的内部调查所取得的结果。这一过程意味着，监管机构将综合考量多方信息，以评估情况全貌。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1162659007","title":"EBR Systems Inc 完成内部调查：一处临床点两名患者出现严重并发症","url":"https://stock-news.laohu8.com/highlight/detail?id=1162659007","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1162659007?lang=zh_cn&edition=fundamental","pubTime":"2026-07-31 07:12","pubTimestamp":1785453130,"startTime":"0","endTime":"0","summary":"EBR Systems Inc（股票代码：EBR.AU）宣布，已针对近期发生在单一临床站点的事件完成内部调查。在该站点，两名患者出现了严重并发症。此次调查旨在厘清事件原委，确保后续流程的合规性与安全性。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1156105448","title":"EBR Systems：两名患者术后出现室颤，一人在术后超声心动图检查中死亡","url":"https://stock-news.laohu8.com/highlight/detail?id=1156105448","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1156105448?lang=zh_cn&edition=fundamental","pubTime":"2026-07-24 12:37","pubTimestamp":1784867871,"startTime":"0","endTime":"0","summary":"EBR Systems报告称，两名患者在植入设备后出现了心室颤动。更令人揪心的是，有一名患者在进行术后超声心动图检查时不幸离世。这一消息无疑为医疗科技领域投下了一枚重磅炸弹。目前，相关事件的详细原因及后续应对措施，仍在进一步的调查与评估之中。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1164728086","title":"EBR Systems Inc内部评估：此事件为独立事件，与已披露风险相关","url":"https://stock-news.laohu8.com/highlight/detail?id=1164728086","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1164728086?lang=zh_cn&edition=fundamental","pubTime":"2026-07-24 12:37","pubTimestamp":1784867828,"startTime":"0","endTime":"0","summary":"EBR Systems Inc（EBR SYSTEMS INC-CDI）表示，其内部评估认定，这一事件属于孤立事件，且与先前已披露的风险因素相关联。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":1,"pageCount":1,"totalSize":8,"code":"91000000","status":"200"}]}}