Big news from Helms Workshop and SKU alum Mosie Baby: The innovative brand is the first company to receive FDA Class II clearance for its over-the-counter, at-home intravaginal insemination (IVI) device.
This phenomenal achievement involved rigorous clearance procedures, including thorough clinical and technical testing to validate the device’s similarity to medical instruments used in IUI and IVF. The clearance also confirms the device’s safety and, importantly, authorizes it for both fresh partner semen and frozen donor sperm, expanding its potential in reproductive healthcare.
After struggling to conceive for 2.5 years, Maureen and Marc Brown began looking for an easy and comfortable at-home way to inseminate. When they couldn’t find it, they decided to make it. And that’s how the Mosie Baby Kit was born.
“To date, we’re very proud to share that Mosie Baby has helped more than 100K families inseminate from the comfort of their own homes. We are now thrilled to offer our device as an FDA-reviewed option for families looking to inseminate at home,” says co-founder Maureen. We couldn’t be prouder to help build the brand.
