FDA Designates Renovia’s Leva Digital Therapeutic for Incontinence a Breakthrough

Renovia has received a Breakthrough Device designation from the FDA for its leva Digital Therapeutic System as a first-line treatment for chronic fecal incontinence in women.

The system is a small wand combined with a smartphone app that offers a drug-free way for women to train and strengthen their pelvic floor muscles. The treatment can be done at home and takes just five minutes a day, Renovia said.

The device already has 510(k) clearance to treat urinary incontinence in women, according to the Boston, Mass.-based company, which specializes in developing digital therapeutics for female pelvic floor disorders.