Mosie Baby has received class 2 FDA clearance for its Mosie Baby Kit for use in intravaginal insemination (IVI), making it the first of its kind, according to the company.1
Takeaways
- Mosie Baby has achieved class 2 FDA clearance for its Mosie Baby Kit, marking it as the first FDA-cleared at-home intravaginal insemination (IVI) kit.
- The Mosie Baby Kit is an at-home insemination solution that includes 2 syringes, designed with a barrel-free tip and slit opening for optimal efficacy and minimal waste. The kit facilitates at-home insemination with either fresh or cryogenically frozen donor semen samples, utilizing 2 proprietary collection cups for semen collection.
- Mosie Baby recommends users attempt pregnancy twice per ovulation cycle, reinforcing this suggestion by including 2 syringes in each kit.
- Prior to receiving FDA clearance, the Mosie Baby Kit underwent rigorous clinical and technical testing, including vaginal irritation testing, Human Sperm Survival Assay, and biocompatibility testing. The results confirmed the kit as non-sensitizing, non-irritating, non-cytotoxic, and free from microbial contamination.
- Maureen Brown, the co-founder and CEO of Mosie Baby, notes that approximately 1 in 6 individuals experience infertility. The FDA clearance of the Mosie Baby Kit provides a valuable option for this population to perform intravaginal insemination within the comfort of their homes.
The Mosie Baby Kit is an at-home insemination kit with 2 syringes. Mosie Baby designed the kit for use in patients who cannot conceive through intercourse. It is used to perform at-home insemination with a fresh or cryogenically frozen donor semen sample, with 2 proprietary collection cups used for semen collection.
The syringe uses a barrel-free tip and slit opening to ensure the greatest available efficacy and minimum waste, and the collection cup was designed to collect the greatest sample possible. Mosie Baby recommends patients attempt pregnancy twice per ovulation cycle and supported this suggestion by including 2 syringes in each kit.2
The Mosie Baby Kit also contains instructions for easy use. Patients in the United States with additional questions are able to reach out to a team at Mosie Baby for assistance.
The Mosie Baby Kit was evaluated through clinical and technical testing prior to the FDA class 2 clearance.1 Testing included vaginal irritation testing, Human Sperm Survival Assay, and biocompatibility testing. These tests confirmed the Mosie Baby Kit as non-sensitizing, non-irritating, non-cytotoxic, and without microbial contamination.
According to Maureen Brown, co-founder and CEO of Mosie Baby, infertility is experienced by approximately 1 in 6 individuals. Through the class 2 FDA clearance of the Mosie Baby Kit, this population will have the option to inseminate within their homes, as the Mosie Baby Kit is the only FDA-cleared over-the-counter kit for use in IVI.
Currently, the Mosie Baby Kit is available at mosiebaby.com, CVS.com, and select CVS stores. Mosie Baby plans to expand access across retailers and health care partners in 2024.
Reference
- Mosie Baby becomes the first company to receive FDA clearance for at-home intravaginal insemination. Prnewswire. December 6, 2023. Accessed December 6, 2023. https://www.prnewswire.com/news-releases/mosie-baby-becomes-the-first-company-to-receive-fda-clearance-for-at-home-intravaginal-insemination-302003665.html
- How Mosie works. Mosie Baby. Accessed December 6, 2023. https://mosiebaby.com/pages/how-it-works
