Imaging Diagnostic Systems (fka IMDS)

[LongnShortOfIt]

So you're posting the same thing I did now supporting my assertion...

They were REJECTED by the FDA for the 510(k) and have NOTHING in front of them now!! Sheesh. you're tough!

Understanding that the above statements were a fair representation of the regulatory industry's general feelings towards the FDA De Novo process, management decided to accept and heed the FDA's letter (received on August 2, 2011) detailing their decision of CTLM® being “not substantially equivalent” and furthermore, accepting their recommendation that CTLM® is a class III device that would require a PMA submission.