Diagens-B (02526.HK): Core Product AI AutoVision® Obtains NMPA Class III Medical Device Registration Certificate
NewTimeSpace News: Hangzhou Diagens Biotechnology Co., Ltd. (02526.HK) announced that its core product AI AutoVision® was granted the Class III Medical Device Registration Certificate by the National Medical Products Administration (NMPA) on May 20, 2026. The approved indications cover chromosome karyotype analysis for prenatal diagnosis of birth defects using amniotic fluid samples, and chromosome karyotype analysis for assisted reproductive technology using peripheral blood samples. This is the world's first Class III medical device registration certificate for chromosome karyotype analysis with anomaly recognition capability at Level 3 (L3) autonomy, and also the first medical device registration certificate based on large model technology.
NewTimeSpace News: Hangzhou Diagens Biotechnology Co., Ltd. (02526.HK) issued a voluntary announcement on May 22, 2026, disclosing that its core product AI AutoVision® obtained the Class III Medical Device Registration Certificate from the NMPA on May 20, 2026.
AI AutoVision® is an intelligent chromosome karyotype analysis product built on the Group's iMedImage® medical imaging large model. It assists in chromosome segmentation, counting and arrangement, and provides anomaly recognition prompts to support physicians in clinical diagnosis. To the best of the Board's knowledge and based on currently available information, this registration certificate is the world's first Class III medical device registration certificate for chromosome karyotype analysis with anomaly recognition capability at L3 level, as well as the first medical device registration certificate obtained based on large model technology.
The Board believes that the issuance of this certificate reflects the regulatory authority's recognition of the safety, efficacy and clinical application value of the iMedImage® medical imaging large model technology in medical devices. This registration certificate marks an important regulatory milestone for AI AutoVision® and lays the foundation for the commercialization of the core product within the approved indications.
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