Check-Cap Receives FDA IDE Approval for Pivotal Study of C-Scan®
today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational Device Exemption (IDE) application, permitting Check-Cap to begin a pivotal study of C-Scan in the U.S.
The pivotal study will evaluate safety and performance of C-Scan as well as subject compliance with C-Scan.
Now with IDE in hand, we aim to enter the last phase of demonstrating the clinical potential of C-Scan in the U.S., with the ultimate goal of commercialization in this important market.
"We are in active discussions with a number of clinical sites as part of our preparations to begin the pivotal study in late 2021.
finance.yahoo.com/ne...a-ide-110000884.html
today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational Device Exemption (IDE) application, permitting Check-Cap to begin a pivotal study of C-Scan in the U.S.
The pivotal study will evaluate safety and performance of C-Scan as well as subject compliance with C-Scan.
Now with IDE in hand, we aim to enter the last phase of demonstrating the clinical potential of C-Scan in the U.S., with the ultimate goal of commercialization in this important market.
"We are in active discussions with a number of clinical sites as part of our preparations to begin the pivotal study in late 2021.
finance.yahoo.com/ne...a-ide-110000884.html