This from HY report on 25/02
"Following this feedback, Optiscan continued to prepare its submission for 510(k) clearance to market the InVivage™ device for legal sale in the United States in Oral Cancer Screening and/or Surgery. During the period Optiscan commenced the third party validation and verification testing required to be completed for the 510(k) submission. Optiscan and the Melbourne Dental School also commenced the dosing study for the topical use of fluorescein, indicated by the FDA as one of the requirements for Optiscan’s intended 510(k) application."
Note that they mention "dosing study for the topical use of fluorescein" - I think this refers to PARPI-FL from Summit (unless they are trying different cancer markers). Maybe they are not mentioning name so competitors cant get a jump on.
This from HY report on 25/02 "Following this feedback, Optiscan...
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