Medical artificial intelligence company KaiHealth 's artificial intelligence embryo analysis software (Vita Embryo), which received Class 3 medical device approval, has been designated as an innovative medical device by the Ministry of Food and Drug Safety.
Innovative medical devices are medical devices that have significantly improved or are expected to significantly improve safety and effectiveness compared to existing medical devices or treatments through the application of cutting-edge technology or improvements in usage methods, and are designated by the Commissioner of the Ministry of Food and Drug Safety.
Recently, as the age of marriage and pregnancy increases, the number of patients who have difficulty in natural pregnancy continues to increase. In addition, repeated pregnancy failures and the financial burden of IVF treatment are raising physical and mental health problems in women. Kai Health's artificial intelligence technology is expected to support the priority determination of embryos with high pregnancy potential and increase the success rate of IVF treatment, effectively overcoming the problems of infertility and low birth rate.
Kai Health is currently checking with the Health Insurance Review & Assessment Service to determine whether the technology is eligible for medical care benefits or not, and based on the results, it is applying for a ‘new medical technology assessment deferral’ to the Korea Health Industry Development Institute (NECA) and aims to receive a final non-coverage fee this year.
“Infertility treatments have high technological barriers and a shortage of medical staff, so AI technology can be of great help,” said Lee Hye-jun, CEO of Kai Health and a former obstetrician/gynecologist specializing in infertility. “We want to successfully pass the innovative medical device designation and new medical technology assessment, and quickly expand globally starting with the domestic market to help more infertile couples have healthy babies.”
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