Vita Embryo analyzes day-5 embryo images with deep learning to predict pregnancy likelihood and suggest transfer priority

Kai Health (CEO Hyejun Lee) announced on the 11th that its AI-based embryo morphology analysis software, Vita Embryo, has been selected as a “New Health Technology” under the assessment deferment program administered by the National Evidence-based Healthcare Collaborating Agency (NECA). The technology was recognized under the category of “AI-based morphological outcome analysis of embryo culture.”

NECA determines whether to grant assessment deferment by comprehensively reviewing factors such as the target population and purpose of use, safety, and clinical necessity. Kai Health’s technology received strong evaluations for (1) clarity of the intended users and purpose and (2) acceptability of safety, and was deemed to meet the deferment criteria under Article 3, Paragraph 5 of the “Regulations on New Health Technology Assessment.”

The assessment deferment program allows innovative medical technologies to be used in real-world clinical settings for a defined period before the full assessment is completed. Through this process, medical institutions can adopt new technologies earlier and generate clinical data, while patients may gain access to advanced medical benefits sooner.

Vita Embryo is a clinical decision-support tool that analyzes day-5 embryo images captured during IVF using deep learning to predict pregnancy likelihood and suggest transfer priority. The company stated that the technology has been validated through multi-center clinical studies and has obtained medical device certifications in Korea, Europe, Singapore, and India.

During the deferment period, Kai Health plans to deploy its solution in clinical practice across domestic and overseas medical institutions to gather additional evidence and further enhance the technology’s performance and safety.

The company also plans to pursue U.S. market entry in parallel by proceeding with the FDA 510(k) clearance process, while expanding into Asian markets such as India and Thailand, as well as European markets including Türkiye, the UK, and France.

CEO Hyejun Lee said, “This selection recognizes both the safety and clinical value of Kai Health’s AI-based embryo analysis technology,” adding, “We will continue building scientific evidence based on clinical data accumulated during the deferment period, and we will keep working so that more couples facing infertility can have the chance to welcome a healthy baby through Kai Health’s solution.”