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 ISFIYA，2022 年 2 月 7 日/新聞通訊社/-檢查帽有限公司（「公司」或「檢查帽」）（NASDAQ：CHEKZ），一家臨床階段醫學診斷公司，推進 C-Scan® 的開發，這是首個也是唯一一個患者友好的無準備篩查以檢 test 到結腸癌（CRC），可以在結腸癌之前進行檢測到瘜肉（CRC）今天宣布，該公司已獲得美國食品和藥物管理局（FDA）批准其修訂的試驗設備豁免（IDE）申請，以啟動美國關鍵研究。
譯文內容由第三人軟體翻譯。
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