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Ellex Medical Lasers Ltd Secures US FDA Approval for 2RT in Treatment of Diabetic Eye Disease

Wednesday, 17 Jul 2013 07:42pm EDT 

Ellex Medical Lasers Ltd announced that it has secured US FDA 510(k) approval for its Retinal Rejuvenation Therapy (2RT) in the treatment of Clinically Significant Macular Edema (CSME), the most common form of diabetic eye disease which can result in legal blindness. This follows the Company's announcement in 2012 that it had received a CE Mark (European Conformity) for 2RT for the same indication. Whilst treatment options already exist for CSME, including the Company‚Äôs Integre photocoagulation laser portfolio, 2RT achieves similar clinical outcomes without the collateral damage to the retina associated with conventional thermal photocoagulation. 

Company Quote

19 Dec 2014