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Check-Cap Announces FDA Approval Of Amended IDE Application For Pivotal Study Of C-Scan

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.

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