JUNOFEM, a medical equipment supplier based in Auckland, New Zealand, has taken a significant step toward introducing their innovative ‘femfit’ female incontinence device to the American market by applying for FDA approval. After two years of dedicated work on their 510(k) pre-market submission, JUNOFEM aims to gain access to the US market upon FDA approval.

The femfit® Pelvic Floor Training Tool is a cutting-edge device designed for female pelvic floor muscle exercises. It features a thin, flexible silicone sensor connected to a module containing the device electronics. Inserted temporarily into the vagina during exercise sessions, it uses a row of pressure sensors to measure pelvic floor muscle contractions and abdominal pressure, relaying this data wirelessly to a bespoke app on the user’s phone for real-time feedback on technique. This single patient, reusable device, battery-powered and rechargeable via a USB-powered charging case, is intended for over-the-counter supply for home or clinical use.

Already approved for sale in New Zealand, Australia, and the UK, JUNOFEM anticipates the FDA’s decision within 60 days. Dr David Budgett, a co-creator of femfit, highlights the stringent international standards met by the device, including design processes, device labeling, and software development, setting a strong foundation for FDA assessment.

Budgett expresses enthusiasm about the potential US expansion: “JUNOFEM is already supporting British, Australian and New Zealand women with their pelvic floor health, and is very excited to have submitted their 510(k) premarket submission to the FDA. The next step is extending our support to American women. Pelvic floor health is a global issue… With femfit, women can know they are exercising correctly and their efforts will be worthwhile.”

The femfit® is distinct in its use of multiple pressure sensors and the ability to provide feedback on contraction effectiveness, supporting functional training in various positions. With the FDA overseeing a vast range of medical devices, JUNOFEM’s submission meets rigorous standards for quality, safety, and effectiveness, aligning with other FDA-approved devices.

Some interesting current numbers from the FDA at www.fda.gov/about-fda/economics-staff/fda-glance