The US Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to Atlantic Therapeutics’ INNOVO, a wearable, non-invasive device for stress urinary incontinence (SUI).

SUI is an accidental leakage of urine due to the pressure on the bladder during coughing, sneezing, laughing or exercising.

The device treats the root cause of SUI by strengthening the entire network of pelvic floor muscles through gentle muscle stimulation.

It was previously available in the US by prescription.

Atlantic Therapeutics CEO Steve Atkinson said: “With INNOVO now approved for over-the-counter use, women suffering from urinary incontinence, a common but stigmatized condition, have easy access to this convenient, effective and safe product, which is backed by science.

“No longer requiring a prescription for INNOVO means women can take back control of their personal health in the safest and most convenient way possible with this effective at-home treatment. They no longer need to suffer in silence and make do with temporary fixes, such as pads, to manage their condition.”

Atlantic Therapeutics claimed to have delivered 3.5 million therapy sessions worldwide for women suffering from SUI.

INNOVO co-inventor and Philadelphia College of Osteopathic Medicine (PCOM) Georgia Department of Physical Therapy professor Ruth M Maher said: “INNOVO is a revolutionary device that offers women a safe, clinically effective and truly non-invasive choice to treat the root cause of bladder leaks rather than just the symptoms.

“Simple to use and wearable, INNOVO fits into a busy lifestyle. In the privacy of their own home, women can simply pull on a pair of shorts for a 30-minute INNOVO pelvic floor workout. By strengthening and re-educating their pelvic floor muscles, they have the opportunity to live a leak-free life in as little as three months.”

Available in variable sizes, the device has a pull-on shorts design.

Atlantic Therapeutics claimed that INNOVO is safer to use compared to any other EMS therapy.