DIAGENS-B (02526) surged more than 22% in morning trading, reaching a high of HK$428 and setting a new record high since its listing. As of the time of writing, the stock was up 17.43% to HK$411, with a turnover of HK$29.2139 million.

The company announced that its self-developed AI AutoVision® chromosome karyotype assisted diagnosis software has officially obtained a Class III Medical Device Registration Certificate from the National Medical Products Administration. The approved indications cover chromosome karyotype analysis for prenatal diagnosis of birth defects using amniotic fluid samples, as well as for assisted reproduction-related chromosome karyotype analysis using peripheral blood samples.

According to the board's knowledge and currently available information, this registration certificate is the world's first Class III medical device registration certificate for chromosome karyotype analysis with anomaly recognition capabilities at the L3 level. It is also the first medical device registration certificate obtained based on large model technology.

The board believes that the acquisition of this certificate reflects regulatory recognition of the safety, effectiveness, and clinical application value of the iMedImage® medical imaging large model technology in medical devices.