In Brief: Autonomous Technologies' LADARVision
This article was originally published in The Gray Sheet
Executive Summary
Autonomous Technologies' LADARVision: Company's laser vision correction device is unanimously recommended (6-0) for approval, with conditions, by FDA's Ophthalmic Devices Panel at a Feb. 13 meeting in Rockville, Maryland. Autonomous Technologies submitted a premarket approval application for the excimer laser-based system in September. The device is capable of performing "tracker-assisted" photorefractive keratectomy. Conditions for approval recommended by the panel included narrowing the indication to use in patients with -1 to -8 diopters of myopia and up to four diopters of astigmatism. The company is seeking approval for treatment of -1 to -10 diopters of myopia and up to eight diopters of astigmatism...