Congratulations to lensgen team on this significant milestone: IDE Approval from the U.S. FDA to Begin Clinical Study
Great news for LensGen, Inc. The approval of their IDE will allow the company to begin their pivotal trial with the ultimate goal of seeking premarket approval. Congratulations to Ram and the team! Their persistence and dedication is inspiring.
LensGen, Inc., a privately held ophthalmic medical device company, announced today that it has received approval for an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal study of the company's Juvene intraocular lens (IOL) for patients with cataracts.
The LensGen Juvene IOL is designed to permanently restore clear and continuous vision at all distances including near and intermediate. The lens is modular and has a fluid optic component that changes shape to adjust focus on demand for today's active lifestyles, from viewing mobile devices and computer screens to high-quality distance vision in a broad range of lighting conditions. The lens is implanted using the same surgical techniques used with traditional intraocular lenses. Full press release.
Watch LensGen's Panel Discussion at ASCRS in Las Vegas Last August