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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

Check-Cap公司宣布FDA批准修改后的IDE应用程序用于C-SCAN的关键研究
Benzinga Real-time News ·  2022/02/07 08:35

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ISFIYA,2022年2月7日/美通社/--纳斯达克:CHEK)Check-Cap Ltd.(以下简称“公司”或“Check-Cap”),一家推进C-SCAN®开发的临床期医疗诊断公司(纳斯达克代码:CHEKZ)今天宣布,该公司已获得美国食品和药物管理局(FDA)的批准,用于在息肉转化为结直肠癌之前发现息肉,这是第一种也是唯一一种对患者友好的免准备筛查测试,可在息肉转化为结直肠癌之前发现息肉。

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