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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公司宣佈FDA批准修改後的IDE應用程序用於C-SCAN的關鍵研究
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/--納斯達克:CHEK)Check-Cap Ltd.(以下簡稱“公司”或“Check-Cap”),一家推進C-SCAN®開發的臨牀期醫療診斷公司(納斯達克代碼:CHEKZ)今天宣佈,該公司已獲得美國食品和藥物管理局(FDA)的批准,用於在息肉轉化為結直腸癌之前發現息肉,這是第一種也是唯一一種對患者友好的免準備篩查測試,可在息肉轉化為結直腸癌之前發現息肉。

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