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EBR SYSTEMS INC-CDI

0.245

0.000

成交量：5.96萬

成交額：1.46萬

市值：2.07億

市盈率：-1.32

高：0.250

開：0.245

低：0.245

收：0.245

52周最高：1.470

52周最低：0.235

股本：8.45億

流通股本：3,748.74萬

量比：0.10

換手率：0.16%

股息：- -

股息率：- -

每股收益(TTM):-0.186

每股收益(LYR):-0.165

淨資產收益率：-102.51%

總資產收益率：-28.46%

市淨率：2.13

市盈率(LYR):-1.49

資料載入中...

總覽公司新聞資訊公告

EBR Systems宣佈計劃於2026年第四季度向FDA提交變更生效（CBE）上市前批准（PMA）補充申請

EBR Systems Inc：網絡猜測源於涉事站點的強制事件報告，並非美國FDA審查

EBR Systems Inc稱現階段無持續擔憂，其他站點商業植入正常進行

EBR Systems Inc 事件：FDA將依據現場信息與公司內部調查結果進行審查

EBR Systems Inc 完成內部調查：一處臨床點兩名患者出現嚴重併發症

EBR Systems：兩名患者術後出現室顫，一人在術後超聲心動圖檢查中死亡

EBR Systems Inc內部評估：此事件為獨立事件，與已披露風險相關

EBR Systems Inc：數據泄露對財務結果影響甚微，公司業務未受任何干擾

EBR SYSTEMS INC：全面調查確認公司網絡存儲信息遭遇未授權訪問

EBR Systems公司網絡系統於2026年2月13日前後遭遇中斷

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Systems宣佈計劃於2026年第四季度向FDA提交變更生效（CBE）上市前批准（PMA）補充申請","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_tw&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":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1114786525","title":"EBR Systems Inc：網絡猜測源於涉事站點的強制事件報告，並非美國FDA審查","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_tw&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":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1167781876","title":"EBR Systems Inc稱現階段無持續擔憂，其他站點商業植入正常進行","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_tw&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":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1146596439","title":"EBR Systems Inc 事件：FDA將依據現場信息與公司內部調查結果進行審查","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_tw&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":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1162659007","title":"EBR Systems Inc 完成內部調查：一處臨床點兩名患者出現嚴重併發症","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_tw&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":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1156105448","title":"EBR Systems：兩名患者術後出現室顫，一人在術後超聲心動圖檢查中死亡","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_tw&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":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1164728086","title":"EBR Systems Inc內部評估：此事件為獨立事件，與已披露風險相關","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_tw&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":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1130937558","title":"EBR Systems Inc：數據泄露對財務結果影響甚微，公司業務未受任何干擾","url":"https://stock-news.laohu8.com/highlight/detail?id=1130937558","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1130937558?lang=zh_tw&edition=fundamental","pubTime":"2026-04-15 06:34","pubTimestamp":1776206055,"startTime":"0","endTime":"0","summary":"EBR Systems Inc-CDI 已确认，近期发生的数据泄露事件预计不会对其财务业绩产生实质性影响。公司方面强调，其日常运营和业务活动均未因此次事件而出现任何中断。\n此次安全事件虽已引起关注，但公司迅速采取了应对措施，有效控制了潜在风险。管理层表示，公司的财务表现和战略规划将按原定轨道继续推进，投资者无需过度担忧。","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},{"id":"1138087185","title":"EBR SYSTEMS INC：全面調查確認公司網絡存儲信息遭遇未授權訪問","url":"https://stock-news.laohu8.com/highlight/detail?id=1138087185","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1138087185?lang=zh_tw&edition=fundamental","pubTime":"2026-04-15 06:33","pubTimestamp":1776205994,"startTime":"0","endTime":"0","summary":"经过深入调查，EBR SYSTEMS INC（ASX: EBR）确认其内部网络系统中存储的特定数据遭到了未授权访问。该公司表示已启动应急响应机制，并正在与网络安全专家合作评估事件影响范围。\n目前调查显示，此次安全事件可能涉及部分商业信息及运营数据。EBR SYSTEMS INC强调，公司正采取必要措施加强网络防护，并已向相关监管机构通报情况。后续进展将通过官方渠道及时披露。","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":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1159999570","title":"EBR Systems公司網絡系統於2026年2月13日前後遭遇中斷","url":"https://stock-news.laohu8.com/highlight/detail?id=1159999570","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1159999570?lang=zh_tw&edition=fundamental","pubTime":"2026-04-15 06:33","pubTimestamp":1776205993,"startTime":"0","endTime":"0","summary":"EBR Systems公司于2026年2月13日左右经历了一起网络中断事件，导致其部分运营系统受到影响。该事件可能对公司的日常运营及服务交付产生潜在影响。","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":"","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":10,"code":"91000000","status":"200"}]}}