MIAMI— Avulux, the manufacturer of clinically-proven precision light-filtering lenses for people living with migraine and light sensitivity, has announced that the U.S. Food and Drug Administration (FDA) has granted the company De Novo marketing authorization—which is used for new, first-of-their-kind types of medical devices—establishing the first FDA-recognized category for a precision optical filter designed to help manage light sensitivity associated with migraine. The authorization gives Avulux a defined regulatory pathway as a first-of-its-kind medical device, one the company said provides patients and clinicians with a clearer way to understand its intended use.