Pelvital’s Pelvic Floor-Muscle Treatment Cleared

The FDA has granted 510(k) clearance to Pelvital for Flyte, an intravaginal device used to strengthen the pelvic floor muscles for the treatment of stress urinary incontinence (SUI).

The non-invasive device is designed for use at home and uses mechanical therapy to treat pelvic floor-muscle weakness, the primary underlying cause of female SUI.

The therapy “essentially turbocharges Kegel exercises, the gold standard conservative treatment for SUI,” said Dale Wahlstrom, Pelvital’s CEO and cofounder.