FDA News Briefs for Thursday, April 12, 2018April 12, 2018
These Food and Drug Administration (FDA) developments came in earlier this week:
FDA Clears Contact Lens With Light-Adaptive Technology
The FDA announced on Tuesday 510(k) clearance for Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology (Johnson & Johnson Vision Care, Inc.). The lenses are indicated for daily use to correct the vision of people with non-diseased eyes who are nearsighted (myopia) or farsighted (hyperopia). They can also be used by people with certain degrees of astigmatism. More Information.
FDA Allows Marketing of Novel Device to Detect Diabetes-Related Eye Problems
The FDA has granted a de novo classification request that allows for the marketing of the first medical device to use artificial intelligence to detect greater than a mild level of retinopathy in adults who have diabetes. The device, called IDx-DR (IDx LLC.), is a software program that uses an algorithm to analyze images of the eye taken with the Topcon NW400 retinal camera. More Information.
FDA Expands Indications for Afinitor Disperz
Novartis announced on Wednesday that the FDA has approved Afinitor Disperz (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. This latest indication was approved based on outcomes of the phase III EXIST-3 trial. More Information.