Previously certified as a medical device in Europe, Singapore, and India

Kai Health announced on the 31st that it has obtained Class III medical device approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its AI-based embryo analysis software, Vita Embryo. The company said this is the first product approval issued in Korea for an AI software solution in the infertility field.

Vita Embryo is a medical device that analyzes embryos created during infertility treatment. The company stated that it successfully completed clinical trials at Seoul National University Bundang Hospital and Good Moonhwa Hospital, submitted an application for medical device approval, and received Class III clearance. Kai Health added that it had previously obtained medical device certifications in Europe, Singapore, and India.

The success of infertility treatment depends on generating, selecting, and transferring high-quality embryos. Currently, embryo selection often relies on subjective judgment by clinicians. Kai Health said its AI technology is expected to improve the accuracy and objectivity of identifying embryos with a higher likelihood of pregnancy, potentially reducing the time and cost required to achieve pregnancy.

Hyejun Lee, CEO of Kai Health and a former infertility specialist OB-GYN, said, “Infertility treatment has a high technical barrier and there is a shortage of medical professionals, so AI technology can be a significant help.” She added, “Starting from the Korean market, we want to expand rapidly globally and help more couples facing infertility have a healthy baby.”

Kai Health said it is the first company in Korea developing an AI solution aimed at improving success rates in infertility treatment. Based on data from 20 hospitals in Korea and abroad, the company developed AI algorithms to help identify embryos with a higher likelihood of pregnancy, and previously obtained medical device certifications in Europe, Singapore, and India. The company added that it plans to establish itself as a family-tech company supporting healthy families across infertility, pregnancy, and contraception.

Source: Medifonews · By Young-hee Noh · Originally published in Korean · English translation