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Izotropic Corporation: Izotropic Reports High Degree of Confidence After Pre-Submission Meeting with FDA


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. ....

United States , United Kingdom , British Columbia , John Mcgraw , Dan Sammartino , Johnm Boone , University Of California , Izotropic Corporation , Izotropic Imaging Corp , Drug Administration , British Columbia Newsfile Corp , Izotropic Corp , Uc Davis Medical Center , Executive Vice President , Commercial Operations , Izotropic Imaging , Izotropic Breast , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் , பிரிட்டிஷ் கொலம்பியா , ஜான் மக்ரா , டான் சம்மர்த்தினோ , பல்கலைக்கழகம் ஆஃப் கலிஃபோர்னியா , அக் டேவிஸ் மருத்துவ மையம் , நிர்வாகி துணை ப்ரெஸிடெஂட் , வணிகரீதியானது செயல்பாடுகள் ,

Izotropic Reports High Degree of Confidence After Pre-Submission Meeting with FDA – IT Business Net


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.” ....

United States , United Kingdom , British Columbia , John Mcgraw , Dan Sammartino , Johnm Boone , University Of California , Izotropic Corporation , Newsfile Corp , Izotropic Imaging Corp , Drug Administration , Izotropic Corp , Uc Davis Medical Center , Executive Vice President , Commercial Operations , Izotropic Imaging , Izotropic Breast , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் , பிரிட்டிஷ் கொலம்பியா , ஜான் மக்ரா , டான் சம்மர்த்தினோ , பல்கலைக்கழகம் ஆஃப் கலிஃபோர்னியா , அக் டேவிஸ் மருத்துவ மையம் , நிர்வாகி துணை ப்ரெஸிடெஂட் , வணிகரீதியானது செயல்பாடுகள் ,

Izotropic Reports High Degree of Confidence after Pre-Submission Meeting with FDA


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. ....

United States , British Columbia , John Mcgraw , Dan Sammartino , Johnm Boone , University Of California , Izotropic Corporation , Izotropic Imaging Corp , Drug Administration , Izotropic Corp , Uc Davis Medical Center , Executive Vice President , Commercial Operations , Izotropic Imaging , Izotropic Breast , ஒன்றுபட்டது மாநிலங்களில் , பிரிட்டிஷ் கொலம்பியா , ஜான் மக்ரா , டான் சம்மர்த்தினோ , பல்கலைக்கழகம் ஆஃப் கலிஃபோர்னியா , அக் டேவிஸ் மருத்துவ மையம் , நிர்வாகி துணை ப்ரெஸிடெஂட் , வணிகரீதியானது செயல்பாடுகள் ,