The FDA has approved Boston-based medical devicemaker Renovia's Ieva Pelvic Digital Therapeutic device, designed to strengthen pelvic floor muscles to treat urinary incontinence in women.
The device, called leva, and has a movement-based sensor that connects to an app to give women real-time feedback as they perform pelvic floor muscle exercises. It was approved Nov. 25.
Urinary incontinence affects an estimated 20 million women in the U.S., and early intervention has been shown to resolve or reduce symptoms and limit the need for more complex treatments, such as surgery or long term medication.
Read the full news release here.