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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):-0.190

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

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新闻资讯

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

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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 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