JUNOFEM has applied for FDA approval for its revolutionary female incontinence device ‘femfit’ in the next step towards being able to sell the device to women in America.
The medical equipment company, based in Auckland, New Zealand, has spent two years working on their 510(k) pre-market submission, which when approved by the US FDA, will open the doors to the American market.
The femfit® Pelvic Floor Training Tool consists of a thin flexible silicone sensor linked to a small module containing device electronics.
The sensor is temporarily inserted into the vagina during an exercise session, for the pelvic floor muscles.
A row of tiny pressure sensors located inside the sensor measure the strength of contraction of the user’s pelvic floor muscles, while simultaneously measuring abdominal pressure.
This information is transmitted wirelessly to a bespoke app on a user’s phone to provide real-time feedback on technique.
It is a single patient, reusable device to be supplied over-the-counter, for use in the home or healthcare clinic.
The femfit® is battery powered and recharged when placed in a USB-powered charging case.
JUNOFEM has already been successful with regulatory assessment leading to approval for femfit® sales in the New Zealand, Australia and UK markets. JUNOFEM expects to receive the FDA’s verdict within 60 days.
Dr David Budgett, one of the creators of femfit said: “There are numerous international standards for design processes, device labelling, electromagnetic compatibility, electrical safety, material safety, medical device software development.
“Showing compliance to these standards set the right tone for the FDA examiners who are assessing that the device has been through a rigorous development and testing process to give confidence in safety and efficacy.
“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. Exercising the pelvic floor muscles is so valuable, but many people have the wrong technique. With femfit, women can know they are exercising correctly and their efforts will be worthwhile.”
The femfit® is a perineometer designed to treat stress, mild-moderate urge, and mixed urinary incontinence in women, by strengthening the pelvic floor muscles through exercise.
The femfit® has novel technological characteristics from other approved devices in terms of:
• Multiple pressure sensors along the length of a flexible sensor assembly.
• Display of feedback to users to show contraction effectiveness, via this sensor array.
• Capacity to support functional training while sitting and standing.
The FDA oversees over 6,500 different medical devices products. Their approval hinges on a number of safety and efficacy criteria which the device must adhere to.
They include documenting risk, identifying hazards, potential for harm, mitigation strategies and residual risk.
JUNOFEM’s submission provides the evidence to verify that the device and its production meets the FDA rigorous standards for quality, safety and effectiveness, consistent with other devices approved by the FDA and in the field.
And the makers must provide evidence to validate that the device delivers on what the user needs.
Some interesting current numbers from the FDA at www.fda.gov/about-fda/economics-staff/fda-glance