- Mosie Baby, a pioneering at-home fertility care company, has secured FDA Class II clearance for its Mosie Baby Kit making it the first and only FDA-cleared over-the-counter kit for use in intravaginal insemination (IVI).
- The kit was created to support those who are unable to conceive with intercourse or for whom intercourse is not an option. Following its FDA 510k Class II clearance, Mosie Baby looks forward to expanding access to its Mosie Baby Kit which was determined to be “substantially equivalent” to a predicate device used in clinically-administered intrauterine insemination (IUI).
FDA-Cleared Over-The-Counter Kit for Intravaginal Insemination
The Mosie Baby Kit is designed for at-home insemination with either fresh or cryogenically frozen donor semen samples. Each kit includes two patented syringes with a barrel-free tip and slit opening for optimal transfer and minimal waste. Additionally, two proprietary collection cups are provided for semen collection, featuring a design that supports maximum collection. The kit has received FDA Class II clearance after rigorous clinical and technical testing, including Human Sperm Survival Assay, vaginal irritation testing, and biocompatibility testing. Mosie Baby confirmed that the device is non-cytotoxic, non-irritating, non-sensitizing, and free from microbial contamination through these tests.
“Nearly 10 years ago, my husband and I were devastated by a diagnosis of unexplained infertility and were desperate for options that were safe, financially accessible and easy to use at home,” said co-founder and CEO Maureen Brown. “Since inventing the Mosie Baby Kit in 2014, we realized we weren’t alone in our fertility journey as it’s reported that one in six people experience infertility. To date, we’re very proud to share that Mosie Baby has helped more than 100,000 families inseminate from the comfort of their own home. We are now thrilled to offer our device as an FDA reviewed option for families looking to inseminate at home.”