Check-Cap Announces FDA Approval Of Amended IDE Application For Pivotal Study Of C-Scan
Check-Cap Announces FDA Approval Of Amended IDE Application For Pivotal Study Of C-Scan
ISFIYA, Israel, Feb. 7, 2022 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ:CHEK), (NASDAQ:CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer (CRC), today announced that the Company has received approval from the U.S. Food and Drug Administration (FDA) for its amended Investigational Device Exemption (IDE) application, enabling initiation of the U.S. pivotal study.
ISFIYA, Israel, Feb. 7, 2022 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ:CHEK), (NASDAQ:CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer (CRC), today announced that the Company has received approval from the U.S. Food and Drug Administration (FDA) for its amended Investigational Device Exemption (IDE) application, enabling initiation of the U.S. pivotal study.
以色列伊斯菲亚，2022年2月7日 /PRNewswire/ — CheckCap Ltd.（“公司” 或 “Check-Cap”）（纳斯达克股票代码：CHEK），（纳斯达克股票代码：CHEKZ），一家推进C-Scan® 开发的临床阶段医学诊断公司今天宣布，C-Scan® 是第一款也是唯一一款在息肉转化为结直肠癌（CRC）之前对其进行检测的患者友好型免制剂筛查测试公司修订后的研究器械豁免 (IDE) 申请已获得美国食品药品监督管理局 (FDA) 的批准，从而使这项美国关键研究得以启动。
译文内容由第三方软件翻译。
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