PeriCoach gains FDA over the counter (OTC) approval
The PeriCoach from Analytica Ltd recently gained FDA over-the-counter (OTC) approval, which clears the way for direct to consumer sales for the medical device and app that monitors pelvic floor exercise. Blue Curve worked with Analytica, assisting them to develop and test the PeriCoach from prototype through to successful FDA certification.
Monitoring and strengthening pelvic floor muscles is vital to address urinary incontinence problems in women. This is a problem that affects up to 37% of women in Australia, with many too embarrassed to seek advice and treatment. Urinary incontinence has a significant economic cost with Deloitte Access Economics estimating it at a cost of $42.9 billion in Australian in 2010. [1]
Women can now easily purchase and use the PeriCoach and app in their own home and see how their pelvic floor strength is improving over time and share this data with their doctor. The PeriCoach as has been certified and medically tested so women can have confidence using this device internally.
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