Colposcopy I meant- I think Company is shying away from main use with Pap Smear and more with Colposcopy ,which is used when pap smear shows a problem..This decreases market value.. The FDA process is slow in evaluating devices but that has nothing to do with the the Company NOT submitting the full PMA application.What is Guided Therapeutics excuse for this prolonged delay? -The Light Touch pre-clinical module was submitted 2 years ago! FDA awaits the Clinical and Manufacturing module of the Device and until then Light Touch will not be approved. FDA has NOT received module 2 and module 3 >though Company has made promises for almost 2 years now...., thats my Concern.
I don't think the company can submit manufacturing and clinical modules until they have a detailed plan, which in this case requires the agreement of manufacturing partner(s). Also, the company states that it is working with third party insurers who will provide reimbursement, etc. to patients. Without this financial "structure" the Light-Touch would, if introduced prematurely, exist in a marketing vacuum. Perhaps the delay involves the detailed structuring of the business end with partners.
As far as colopscopy is concerned, it will be used in the case of an abnormal reading with Lite-Touch, just as it is used with an abnormal pap smear. The Light-Touch is a screening tool. All screening tools require a biopsy when an abnormal reading comes up.