Recently, U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have released their summaries on medical device innovation in 2022.

On February 7 2023, RocGene's independently developed Archimed Mini 16 Medical Fluorescence Quantitative PCR Instrument obtained the Class III Medical Device Registration Certificate by the National Medical Products Administration.

On January 5, 2023, Guangzhou Darui Biotechnology Co., Ltd., the subsidiary of Daan Gene Co., Ltd., received China National Medical Products Administration (NMPA) class III medical device approval for its “Twenty Genetic Deafness Genes Mutation Detection Kit (Time of Flight Mass Spectrometry)”.

On Dec. 1st, Sansure announced that its bordetella pertussis nucleic acid test kit (PCR-fluorescent probe method) obtained the certificate approved by NMPA.

Recently, the AutraMic mini4800 Plus developed by Shanghai ZJ Bio-Tech Co.,Ltd. was approved by National Medical Products Administration. It was the smallest and more automated integrated magnetic bead method + fluorescent PCR nucleic acid detection system.

Chinese sequencing tech company GeneMind Biosciences said earlier this month that its single-molecule DNA sequencer, GenoCare 1600 (originally developed by Direct Genomics), has been approved by China's National Medical Products Administration (NMPA) for clinical and diagnostic applications.

On April 13, National Medical Products Administrations (NMPA) reviewed and approved Zhuhai Livzon Diagnostics Inc. and Shanghai BioGerm Medical Technology Co., Ltd's COVID-19 Antigen Test.

In January 2021, Mindray Medical signed an AI cooperation framework agreement with Tencent AI Lab.

On March 17th, NMPA has approved the 14th New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) produced by Zybio. Up to now, 14 COVID-19 antigen detection kits have been approved for sale.

Jiangsu Mole Bioscience obtained the approval of the Helicobacter pylori 23S rRNA gene and gyrA gene mutation test kit (fluorescence PCR method) by NMPA. This kit is the first product in China that can simultaneously detect clarithromycin and levofloxacin resistance genes.