Izotropic Corporation: Izotropic Reports High Degree of Confidence After Pre-Submission Meeting with FDA
Izotropic Corporation (CSE:
Izotropic or the
Company ) announces it has received the finalized meeting minutes from the U.S. Food and Drug Administration (FDA) in connection with the Company s recent pre-submission meeting and the market approval process for its commercial Breast CT Imaging System.
Dr. John McGraw, Executive Vice-President of Commercial Operations, stated, I am pleased to report that the meeting with the FDA was very beneficial for Izotropic and the comments received have validated our clinical study plan and development efforts to date. The initial indication for use for breast CT as a diagnostic device has been confirmed, and we have come away from the meeting with a high degree of confidence in our U.S. market approval plan moving forward.
Izotropic” or the “
Company“) announces it has received the finalized meeting minutes from the U.S. Food and Drug Administration (FDA) in connection with the Company’s recent pre-submission meeting and the market approval process for its commercial Breast CT Imaging System.
Dr. John McGraw, Executive Vice-President of Commercial Operations, stated, “I am pleased to report that the meeting with the FDA was very beneficial for Izotropic and the comments received have validated our clinical study plan and development efforts to date. The initial indication for use for breast CT as a diagnostic device has been confirmed, and we have come away from the meeting with a high degree of confidence in our U.S. market approval plan moving forward.”
Izotropic Reports High Degree of Confidence after Pre-Submission Meeting with FDA
VANCOUVER, BC - TheNewswire - December 15, 2020 - Izotropic Corporation ( Izotropic or the Company ) (CSE:IZO) (CNSX:IZO.CN) (OTC:IZOZF) (FSE:1R3) announces it has received the finalized meeting minutes from the U.S. Food and Drug Administration (FDA) in connection with the Company s recent pre-submission meeting and the market approval process for its commercial Breast CT Imaging System.
Dr. John McGraw, Executive Vice-President of Commercial Operations, stated, I am pleased to report that the meeting with the FDA was very beneficial for Izotropic and the comments received have validated our clinical study plan and development efforts to date. The initial indication for use for breast CT as a diagnostic device has been confirmed, and we have come away from the meeting with a high degree of confidence in our U.S. market approval plan moving forward.