FDA grants clearance for home-use artificial insemination kit

Key takeaways:

• Mosie Baby was granted FDA clearance for an over-the-counter intravaginal insemination syringe.
• The insemination device was deemed “substantially equivalent” to one currently used in clinics.

The FDA granted clearance for an over-the-counter kit for use at home in intravaginal insemination for adults who cannot or do not want to use intercourse to conceive, according to an industry press release.

The first device cleared for OTC sale, the at-home insemination Mosie Baby Kit can be used with fresh or cryogenically frozen semen. The kit includes two syringes with a patented design to optimize transfer and minimize semen waste while limiting vaginal irritation. The kit also includes two proprietary semen collection cups.

The FDA found the Mosie Baby product to be “substantially equivalent” to one used in clinics. The OTC kit sells for $129.99 and is available at the company website, CVS, Walmart and other retailers, according to the release.