ReVision Optics said today the FDA accepted its premarket approval application for the Raindrop near vision inlay. The Raindrop is a microscopic hydrogel inlay for treating presbyopia, which the Lake Forest, Calif.-based company said could reduce or eliminate the need for reading glasses. The inlay is placed in the cornea of the patient’s non-dominant eye […]
ReVision Optics Inc.
ReVision Optics files final PMA module for Raindrop inlay
ReVision Optics said Monday it submitted the final module of its premarket approval application for its Raindrop near vision inlay. The Raindrop is a microscopic hydrogel inlay for treating presbyopia, which the Lake Forest, Calif.-based company said could reduce or eliminate the need for reading glasses. Data for the 4th and final module submitted came from […]
Big 100 West: Compliance, competition and the cash incentive
Compliance concerns may be driven largely by the desire to say out of the regulatory spotlight, but it’s also a business strategy, a panel of experts told an audience during this week’s MassDevice.com Big 100 West event in Orange County, Calif.
ReVision Optics sees $55M funding round
ReVision Optics said it’s raised $55 million from a consortium of investors and closed enrollment in a clinical trial of its Raindrop near vision inlay to treat presbyopia.
Amgen mourns death of founder George Rathmann | Personnel Moves
PPD CEO David Grange to retire | Personnel moves
Here’s the latest personnel changes from medical device, diagnostics and life science companies around the nation. For more news on recent hirings and firings in the industry, check out MassDevice’s compilation of the latest personnel moves.
ReVision files for expansion to eye implant clinical trial
ReVision Optics Inc. finished the first stage of a clinical trial for its Vue+ lens eye-implant, only to file for an expansion with the Food & Drug Administration.
The Lake Forest, Calif.-based developer of implantable optics plans to evaluate 400 subjects in a three-year trial for its Vue+ device, formerly called the PresbyLens. The company designed the implantable lens to treat presbyopia, the common age-related loss of the ability to focus one’s eyes for near vision. More than 73 million people in the U.S. are presbyopic, according to the company.