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
Penafian
Maklumat dan penerbitan adalah tidak dimaksudkan untuk menjadi, dan tidak membentuk, nasihat untuk kewangan, pelaburan, perdagangan dan jenis-jenis lain atau cadangan yang dibekalkan atau disahkan oleh TradingView. Baca dengan lebih lanjut di Terma Penggunaan.
Penafian
Maklumat dan penerbitan adalah tidak dimaksudkan untuk menjadi, dan tidak membentuk, nasihat untuk kewangan, pelaburan, perdagangan dan jenis-jenis lain atau cadangan yang dibekalkan atau disahkan oleh TradingView. Baca dengan lebih lanjut di Terma Penggunaan.