New Zealand-based JUNOFEM is on the verge of a significant breakthrough in the American healthcare market with their application for FDA approval of the ‘femfit’ female incontinence device. The company has spent two years preparing their 510(k) pre-market submission to the US FDA, with the goal of bringing this revolutionary product to women in America.
The femfit® Pelvic Floor Training Tool, comprising a slender silicone sensor linked to an electronics module, is designed for use during pelvic floor muscle exercises. The sensor, inserted vaginally during exercise, measures pelvic floor muscle strength and abdominal pressure through an array of pressure sensors. This information is wirelessly transmitted to a user-specific app, providing immediate feedback on exercise techniques. Positioned as a single patient, reusable device, the femfit® is suitable for over-the-counter distribution and is battery-operated, rechargeable through a USB-powered charging case.
JUNOFEM’s product has already received regulatory approval in New Zealand, Australia, and the UK. The company anticipates a response from the FDA within the next 60 days. Dr David Budgett, a key figure behind femfit, emphasises the device’s adherence to various international standards, ensuring its safety and efficacy.
Budgett shares his excitement about the potential expansion into the US market: “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.”
Unique for its multi-sensor technology and ability to provide real-time feedback, the femfit® is poised to offer a novel approach to managing stress, mild-moderate urge, and mixed urinary incontinence in women. JUNOFEM’s submission to the FDA showcases the device’s compliance with the highest standards for medical devices, echoing the company’s commitment to quality, safety, and effectiveness.
Some interesting current numbers from the FDA at www.fda.gov/about-fda/economics-staff/fda-glance