Imaging Diagnostic Systems (fka IMDS)

[ronrooster]

Just reading thru the IMDS registration again.This company could yield amazing return if there plans succeed i.e. they recieve China approval.GLTA
IDSI is expecting China FDA (“CFDA”) marketing clearance by the end of 2018, and we will next focus on U.S. FDA marketing clearance. After our December 2015 informational meeting with the FDA, we drafted a revised clinical investigation plan for purposes of the PMA process (“CIP”); however, we have not yet submitted the CIP to the FDA as we have been focusing since 2016 on our initial goal of obtaining CFDA marketing clearance and launching operations in China. We are evaluating our PMA pathway and strategy as additional data and experience from our current trials and the CFDA approval process become available. All of the data and trials we have assembled and conducted to date are for internal evaluation purposes and not for submission to the FDA. Once we have developed a clear PMA strategy in conjunction with our FDA consultants, which we expect to have by mid-2019, all of our clinical trials going forward will be designed to meet the FDA’s requirements for the PMA process.