LensGen® Receives IDE Approval from the U.S. FDA to Begin Clinical Study of the Juvene® Presbyopia-Correcting Intraocular Lens
IRVINE, Calif., Nov. 29, 2021 /PRNewswire/ — 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