BioTuesdays: Verisante to seek FDA approval of Aura skin cancer device
In addition to ramping up distribution of its Aura non-invasive skin cancer detection device this year, Verisante Technology (OTCQX:VRSEF; TSX-V:VRS) is preparing the process to seek FDA approval of Aura, which is already being distributed in Canada and Europe and is approved for sale in Australia.
"We will soon be filing all of our product and clinical data with the FDA in order to seek formal guidance to begin the premarket approval (PMA) process for Aura,” CEO Thomas Braun says in an interview with BioTuesdays.
“We are planning on two years to get FDA approval and are prepared to do a clinical study in the U.S., which would either be a pre-PMA study or a postmarket approval study,” he adds. “Either way, we hope to receive clarity from the FDA this year on the number of patients required for the study and the endpoints so we can retain a CRO.......