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/news/check-cap-receives-fda-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/news/check-cap-receives-fda-ide-110000884.html
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Clause de non-responsabilité
Les informations et les publications ne sont pas destinées à être, et ne constituent pas, des conseils ou des recommandations en matière de finance, d'investissement, de trading ou d'autres types de conseils fournis ou approuvés par TradingView. Pour en savoir plus, consultez les Conditions d'utilisation.