Renovia Receives FDA Clearance for leva® Pelvic Health System as First-line Treatment for Chronic Fecal Incontinence
BOSTON, July 7, 2022 /PRNewswire/ — Renovia Inc. (“Renovia”), a developer of non-surgical, treatments for female pelvic floor disorders and an advocate for women’s health, announced today that the U.S. Food and Drug Administration (FDA) has cleared its leva® Pelvic Health System for the first-line treatment of chronic fecal incontinence (FI) in women. The decision follows the grant of Breakthrough Device Designation by FDA in October 2021. leva had previously been cleared by FDA to treat stress, mixed and mild-to-moderate urinary incontinence (UI) in women. The new indication makes first-line, at-home treatment for FI, also called accidental bowel leakage, available to the over 12 million U.S. women who suffer from the debilitating and progressive condition. Read more…