Analytica Ltd announces the US Food and Drug Administration (FDA) approval of the PeriCoach at-home pelvic floor trainer device as an over-the-counter treatment for stress urinary incontinence and urge incontinence.
The PeriCoach was introduced in 2015 as a prescription treatment to help enable pelvic floor muscle exercise, which is recommended as a first-line treatment for women who experience urinary incontinence. Since then, the product has been studied and clinically evaluated by women’s health physical therapists, urogynecologists, OBGYNs, and urogynecological nurses, with data and studies published in peer-reviewed journals, according to a media release from Analytica Ltd.
“As a physical therapist, I feel confident recommending to my patients, and using on myself, vaginal devices that were developed and evaluated first as medical products,” says Heather Jeffcoat, DPT, founder of Fusion Wellness & Physical Therapy, in the release. “PeriCoach has a well-established profile as an easy-to-use, effective and affordable home pelvic floor trainer. Now, for women who will benefit from PFME, there are no more excuses!” she adds.
“This approval will bring PeriCoach, and the confidence that comes with it, to women in a convenient way,” states Geoff Daly, CEO Analytica Ltd, in the release.
[Source(s): Analytica Ltd, PR Newswire]