Renovia’s Ieva Pelvic Health System Gets 510(k) Clearance

The FDA has granted 510(k) clearance to Renovia’s Ieva pelvic health system for first-line treatment of women with chronic fecal incontinence.

Ieva combines a small vaginal motion sensor with a smartphone app that helps women strengthen their pelvic floor muscles. The training takes just five minutes per day and delivers better results than the use of Kegel exercises alone, the company said.

The FDA issued a Breakthrough Device designation for the system in October 2021. It was previously cleared to treat urinary incontinence in women.