Fertility care company Mosie Baby has secured the US Food and Drug Administration (FDA) Class II approval for its at-home Mosie Baby Kit, designed for intravaginal insemination (IVI).

The Mosie Baby Kit is an at-home insemination kit designed for people who cannot conceive with intercourse or for whom intercourse is not an option.

It features the patented Mosie syringe, which is said to be the first syringe designed, patented, and now US FDA-cleared specifically for at-home IVI.

The over-the-counter kit is intended for use with either a fresh or cryogenically frozen donor semen sample.

It includes two syringes and two proprietary collection cups, created for semen collection.

The design of the cup allows for optimal collection, while the syringe’s barrel-free tip and slit aperture maximise transfer while reducing waste.

The Mosie Baby Kit underwent clinical and technical testing, including Human Sperm Survival Assay, vaginal irritation testing, and biocompatibility testing to get the class 2 clearance.

According to the fertility care company, the insemination kit showed that the device is non-irritating, non-cytotoxic, non-sensitising and free of microbe contamination.

Mosie Baby co-founder and CEO Maureen Brown 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.

“Since inventing the Mosie Baby Kit in 2014, we realised 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 homes. We are now thrilled to offer our device as an FDA-reviewed option for families looking to inseminate at home.”

Mosie Baby At-Home Insemination Kit is available at MSRP: $129.99 for purchase at the company’s website and selected stores in the US.

The kit is expected to be introduced with additional retailers and healthcare partners in the next year.