11 Dec 2023

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

Mosie Baby has recently obtained FDA 510(k) clearance for its pioneering over-the-counter intravaginal insemination (IVI) kit, marking a significant advancement in at-home fertility care. The kit allows individuals to perform insemination using fresh or cryogenically frozen donor semen and includes two syringes with a distinctive barrel-free tip and a slit opening, along with two collection cups. 


Priced at $129.99, the kit is now available for purchase on Mosie Baby's website, Walmart's online platform, and CVS both online and in-store. The FDA's recognition of the kit as "substantially equivalent" to clinically-administered devices underscores its safety and efficacy.


With plans to expand its availability, Mosie Baby is poised to reach more individuals and families dealing with infertility. The company received $1 million in bridge funding in September, highlighting investor confidence in its innovative approach. Additionally, the appointment of Jaime Rooney, a former executive from Target, as Chief Growth Officer in the previous year signifies the company's strategic focus on accelerating revenue growth and widening its impact. This strategic growth aligns with Mosie Baby's mission to address the challenges of reproductive care, which can often be inaccessible and financially burdensome.


Amid a dynamic landscape of digital health companies in the fertility space, Mosie Baby stands out as a provider of accessible and user-friendly solutions. Other notable players include AIVF, leveraging artificial intelligence for embryo quality assessment in IVF, and Kindbody, a comprehensive fertility and reproductive care company offering various services. 


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