Israeli-based device developer Vibrant Gastro initially submitted for FDA 510(k) clearance and won FDA De Novo classification on Aug. 26, Chief Marketing Officer Ben Feldman said today.
The drug-free capsule is indicated for adults with chronic idiopathic constipation who have not experienced relief despite using laxative therapies for at least one month. The new device will be available in select U.S. states early next year, with gradual national expansion throughout 2023.
How the Vibrant pill treats constipation