RE:RE:RE:RE:RE:I believe FDA approval will be fast tracked Then squatty, you need to call the company right away and set things straight..."This project was undertaken prior to the commencement of an FDA application, and provides important insights that will help guide the Company in an FDA-compliant process.
Imagin anticipates initiating preliminary discussions with the FDA regarding the i/Blue Imaging System as soon as possible..." That was from their July 17th, 2018 news release.
and now straight from their new June 2018 Corporate Presentation...
"Regulatory Overview
FDA Pathway
• PMA pathway likely
• Clinical study planned to compare Imagin’s system performance to other imaging devices
currently on the market
• Presumes device will be used with FDA-approved imaging agents and routes of administration
• Expect 12 month process, but could be longer depending on chosen claims, (e.g., non-inferiority vs. superiority)
• Full GMP Compliant Quality Management System (QMS) required..."
Read more at https://www.stockhouse.com/companies/bullboard?symbol=c.ime&postid=28365066#fJWK2ZrQ0yrSuMxd.99