Mosie Baby receives first 510(k) clearance for at-home artificial insemination kit

At-home fertility care company Mosie Baby announced it received FDA 510(k) clearance for the first over-the-counter intravaginal insemination (IVI) kit, which allows individuals to perform at-home insemination using either a fresh or cryogenically frozen donor semen sample. 

Mosie’s home insemination kit includes two syringes with a barrel-free tip and a slit opening, as well as two collection cups for semen collection. The FDA noted that the kit was “substantially equivalent” to a clinical-administered device. 

The kit retails for $129.99, and is available on the company’s website, Walmart’s site or at CVS, online and in-store. 

The company plans to launch the kit with more retailers and healthcare partners in 2024.

“Nearly ten 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,” Maureen Brown, Mosie’s cofounder and CEO, said in a statement. 

“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.”


In September, the Austin-based company received $1 million in a bridge-funding round. 

Last year, Mosie announced the appointment of former Target executive Jaime Rooney as its chief growth officer, who would be responsible for speeding up revenue growth and expanding the company’s reach. At Target, Rooney managed and grew private label brands up&up and Good & Gather. 

Reproductive care can be inaccessible, expensive and fragmented for many individuals. 

Other digital health companies in the fertility space include Israeli fertility startup AIVF, which offers its EMA platform that uses artificial intelligence to assess embryo quality during IVF treatment, and hybrid fertility and reproductive care company Kindbody, which offers egg freezing, gynecological care, contraception care, fertility testing, and virtual wellness and coaching services. 

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