Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit. The kit was developed for those who are unable to conceive with intercourse or for whom intercourse is not an option. It is estimated that one in six people globally is affected by infertility. The kit comes with two syringes and two collection cups for semen collection. The syringe includes a barrel-free tip and slit opening for semen transfer. The kit can be used with either fresh or cryogenically frozen semen and the instructions for use indicate it can be used during the ovulatory phase of the menstrual cycle.
Mosie Baby was co-founded by CEO Maureen Brown, who was diagnosed with unexplained infertility. Brown stated: “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.” Mosie Baby touts their device as a safe and low-cost option those struggling with infertility. Kwame Ulmer, Managing Partner at MedTech Impact Partners stated:
“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.”
The Mosey Baby kit is a Class II medical device, examples of which include catheters, blood pressure cuffs, contact lenses and pregnancy test kits. Medical devices are assigned to one of three classes based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk. Over 40% of medical devices are Class II devices. The Mosie Baby kit is currently the only available device with 501(k) FDA clearance for at-home intravaginal insemination. The 510(k) clearance process included clinical and technical testing such as vaginal irritation testing, biocompatibility testing, and Human Sperm Survival Assay. The kit is available on Mosie Baby’s website, and also retails for $129.99 at CVS and Walmart, and may be available at other retailers in 2024.
Tags
510(k), 510(k) Clearance, FDA clearance, fertility, insemination, IVF, IVI, Mosie, reproduction
