Kai Health’s Embryo Assessment AI Achieves European Medical Device Certification

22 September 2023 | Friday | News

Kai Health, a leading artificial intelligence company specializing in fertility, has obtained the CE mark for its embryo analysis AI solution, marking a significant milestone as the first of its kind in Asia to attain this certification. With this achievement, Kai Health is now poised to deploy its solution in European Union countries and those recognizing the CE certification.
Image Source : Public Domain

Image Source : Public Domain

Kai Health's innovative solution utilizes artificial intelligence to objectively analyze embryo images, providing predictions of embryo viability. This breakthrough technology is expected to make a substantial contribution to one of the most critical stages in infertility treatment - the selection of embryos with a higher likelihood of a successful pregnancy. Kai Health has previously reported improved accuracy in selecting embryos with a higher likelihood of clinical pregnancy than the traditional method, and it holds the potential to enhance pregnancy rates per cycle.


Dr. Hyejun Lee, an OBGYN and CEO of Kai Health, stated, "Traditionally, embryo assessment and selection have heavily relied on human eyes and experiences, which can introduce potential subjectivity and a lack of standardization. Kai Health's proprietary AI algorithm, developed using thousands of embryo images and clinical factors, can provide standardized embryo scores to support clinicians’ decision-making process. With the CE approval, we hope to assist more couples in welcoming healthy babies into their lives."


Kai Health’s AI solution is offered alongside comprehensive laboratory software to streamline workflows at fertility clinics. The company has plans to develop a platform aimed at improving fertility outcomes.


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