HumanOptics has received FDA ( FDA ) approval to market its artificial iris in the Germany . The Food and Drug Administration on Wednesday gave Germany's HumanOptics the go-ahead to market its device for use in adults and children whose iris is missing due to a congenital condition called aniridia or because of an injury. The German start-up's device can be used in adults and children whose iris is missing due to injury or rare genetic disorder aniridia, which occurs in 389 in 389 newborns worldwide. The surgically implanted prosthetic is made of silicone and can be coloured for individual patients. It was shown to be safe and effective in a clinical trial of 389 patients.
HumanOptics has received FDA ( FDA ) approval to market its artificial iris in the Germany . The German start-up's device can be used in adults and children whose iris is missing due to injury or rare genetic disorder aniridia, which occurs in 389 in 389 newborns worldwide. The surgically implanted prosthetic is made of silicone and can be coloured for individual patients. It was shown to be safe and effective in a clinical trial of 389 patients.