Vita Embryo becomes Korea’s first embryo analysis AI software to receive Class III medical device approval

Kai Health (CEO Hyejun Lee) announced on the 27th that its embryo analysis AI software, Vita Embryo, has been designated as an Innovative Medical Device by Korea’s Ministry of Food and Drug Safety (MFDS). The company said Vita Embryo is the first embryo analysis AI solution in Korea to obtain Class III medical device approval.

Under Korean regulations, an Innovative Medical Device designation is granted by the MFDS Commissioner to medical devices that apply advanced technologies or improve methods of use, and that demonstrate—or are expected to demonstrate—significant improvements in safety and effectiveness compared with existing medical devices or treatment methods.

Kai Health also said it is currently working with the Health Insurance Review and Assessment Service (HIRA) to confirm whether the technology will be covered as a reimbursed or non-reimbursed medical service. Based on that process, the company plans to apply to the National Evidence-based Healthcare Collaborating Agency (NECA) for an assessment deferment under the New Health Technology Assessment pathway, with the goal of securing a non-reimbursed fee schedule within the year.

The company expects its AI technology to help prioritize embryos with higher likelihood of pregnancy, improve IVF success rates, and ultimately contribute to addressing infertility and Korea’s declining birth rate.

CEO Hyejun Lee said, “By successfully obtaining the Innovative Medical Device designation and passing the New Health Technology Assessment process, we aim to expand from Korea into global markets and support more couples facing infertility in having a healthy baby.”

Source: Daily Medi · By Gyoyoon Koo (yun@dailymedi.com) · Originally published in Korean · English translation

MFDS Designates Kai Health’s Embryo Analysis AI as an Innovative Medical Device