An at-home fertility care company has received clearance for the first-ever over-the-counter artificial insemination kit from the U.S. Food and Drug Administration.
Mosie Baby Kit is the only FDA-cleared over-the-counter option for intravaginal insemination, the company said, according to USA Today. The company said that its kit was found to be “substantially equivalent” to being administered by a clinic.
The kit is designed to use either a fresh or cryogenically frozen donor semen sample, the company said.
“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.”
“The recent Mosie Baby clearance means hundreds of thousands of underserved people now benefit from an at-home option. The technology adheres to the highest FDA-recognized test standards and is supported by robust clinical performance testing. The team took the time and care to manufacture a quality product. I am delighted to see it become accessible to countless future parents on their fertility journey. The team at Mosie Baby is on a path to becoming the at-home gold standard fertility option.” said Kwame Ulmer, Managing Partner at MedTech Impact Partners and former Deputy Director at FDA.
The kit costs $129.99 and is available on the company’s website, at CVS.com, CVS stores nationwide, Walmart.com and optumstore.com. The kit is expected to be launched at additional retailers and healthcare partners next year, Mosie said.