Artificial insemination kit granted FDA clearance

The US fertility start-up Mosie Baby has received FDA Class II clearance for its at-home insemination kit.

The kit, selected by the Bill and Melinda Gates Foundation to be part of the Designing Motherhood exhibition at the Discovery Center Museum in Seattle, aims to support those unable to conceive with intercourse or for whom intercourse is not an option.

Designed to be used with either a fresh or cryogenically frozen donor semen sample, each kit includes two syringes for at-home insemination and two collection cups for semen collection. The product is the first and only FDA-cleared over-the-counter kit for use in intravaginal insemination (IVI).

“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,” said co-founder and CEO Maureen Brown.

“Since inventing the Mosie Baby Kit in 2014, we realised we weren’t alone in our fertility journey as it is 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.”

Kwame Ulmer, managing partner at MedTech Impact Partners and former deputy director at FDA, said: “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 recognised 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.”

Following its FDA 510k Class II clearance, Mosie Baby is planning to expand access to its insemination kit, aiming to democratise access to family building and eliminate stigma associated with insemination.

The Mosie Baby insemination kit is available for purchase at mosiebaby.com, CVS.com or at select CVS stores nationwide. The kit is expected to launch with additional retailers and healthcare partners in 2024.