Kai Health's AI-powered embryo analysis software gains innovative medical device status

Kai Health, a medical artificial intelligence company, said Tuesday that the Ministry of Food and Drug Safety (MFDS) has designated its embryo analysis AI software, Vita Embryo, an innovative medical device.

The software is Korea's first embryo analysis AI solution to obtain a Class 3 medical device license.

An innovative medical device has significantly improved or is expected to improve safety and efficacy compared to existing medical devices or treatments by applying advanced technology or improving the method of use. The MFDS minister designates such devices.

Kai Health is confirming with the Health Insurance Review and Assessment Service whether the technology is eligible for insurance benefits. Based on this, the company will apply to the National Evidence-based Healthcare Coordinating Agency (NECA) for a “new medical technology evaluation deferral” and aims to obtain unreimbursed fees within the year.

Kai Health expects its AI technology to increase the success rate of IVF procedures by prioritizing embryos with high pregnancy potential and ultimately contribute to solving the problem of infertility and low birthrate.

“Infertility procedures have high technical barriers and a shortage of medical professionals so that AI technology can be of great help,” said Kai Health founder and CEO Lee Hye-jun, a former obstetrician-gynecologist specializing in infertility. “We will help more infertile couples have healthy babies by passing the innovative medical device designation and new medical technology evaluation and entering the global market, starting with Korea.”