Kai Health, a fertility AI company, said on Friday that it obtained European medical device certification for its embryo analysis AI solution, Eve.

Accordingly, the CE certification allows Kai Health to sell Eve to countries in the European Union and other countries that acknowledge the CE certification system. 

Eve is an AI-powered embryo evaluation tool designed to support embryologists in the decision-making process to select the ideal time to use embryos and objectively predict the embryos with the highest fertility probability. 

The company expects to improve the pregnancy rate per cycle by contributing to the selection of embryos with high pregnancy potential, which is one of the most important steps in in vitro fertilization (IVF) treatment. 

At the Asia Pacific Initiative on Reproduction (ASPIRE) conference which is currently being held in Adelaide, Australia, the company will officially announce the CE mark and present the results of a study on the impact of endoderm percentage on embryo grade.  

"Addressing infertility and low birth rates is a global issue," said Kai Health CEO Lee Hye-jun, who is also an obstetrician and gynecologist specializing in infertility. "Through this European medical device certification, we hope that Kai Health's embryo analysis solution will help more infertile couples have healthy babies."