HIT Consultant December 6, 2023
What You Should Know:
- Mosie Baby, a pioneering at-home fertility care company, has secured FDA Class II clearance for its Mosie Baby Kit making it the first and only FDA-cleared over-the-counter kit for use in intravaginal insemination (IVI).
- The kit was created to support those who are unable to conceive with intercourse or for whom intercourse is not an option. Following its FDA 510k Class II clearance, Mosie Baby looks forward to expanding access to its Mosie Baby Kit which was determined to be “substantially equivalent” to a predicate device used in clinically-administered intrauterine insemination (IUI).
FDA-Cleared Over-The-Counter Kit for Intravaginal Insemination
The Mosie Baby Kit is designed for at-home insemination with either fresh or cryogenically frozen...
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