LensGen has received approval for an investigational device exemption from the FDA, paving the way for a pivotal study of the Juvene IOL, according to a company press release.
"We are proud to achieve this significant milestone for the company, which allows us to move forward with the IDE pivotal trial with the ultimate goal of seeking premarket approval in the largest eye care market in the world," Ramgopal Rao, CEO of LensGen said in a press release. "Achieving IDE approval of a novel device is a tremendous undertaking and (Read more...)