Two Imported Devices Gain Innovation Approval in December

NMPA granted innovation approvals to seven devices in December 2023, for indications ranging from cardiovascular, orthopedic, immunology and urology. Among them are two imported devices. Complete List Varian: Proton Therapy System BioNTech Diagnostics: Human Breast Cancer Molecular Subtyping Detection Kit (PCR-Fluorescent Probe Method) Shanghai Kangfei Technology: Cryoablation Equipment and Balloon-type Cryoablation Catheter Beijng Luosenbote: Pelvic Fracture Reduction Surgery Navigation and Positioning System Suzhou Aoruiji: Biodegradable magnesium metal closure clip Wuxi Pamu: Disposable circular pulmonary artery radiofrequency ablation catheter Sichuan Jinjiang Electronic: Single-use Cardiac Pulsed Field Ablation Catheter and Cardiac Pulsed Field Ablation Generator There have been 250 innovation devices approved since 2014 when the pathway was established. To get an English copy of innovation devices catalog, please email [email protected]. We have translated the “ Innovation Device Approval Procedure ” for you. What are the Imported Devices Varian: Proton Therapy System The product consists of an accelerator subsystem and a treatment subsystem. It is the first approved proton therapy system in China that utilizes a superconducting cyclotron accelerator and a 360-degree rotating gantry. It is suitable for treating whole-body solid malignant tumors and benign diseases such as trigeminal neuralgia. The product employs superconducting cyclotron accelerator technology, and the 360-degree rotating gantry allows for multi-angle treatments. With a quick start-up speed, it can shorten patient treatment time while ensuring effective treatment outcomes, thus enhancing patient comfort. BioNTech Diagnostics: Human Breast Cancer Molecular Subtyping Detection Kit (PCR-Fluorescent Probe Method) This product consists of a detection system mixed solution, enzyme mixed solution, positive control, and negative control. It is used for in vitro semi-quantitative detection of mRNA expression levels of the genes ERBB2 (HER2), ESR1 (ER), PGR (PR), and MKI67 (Ki-67) in FFPE (formalin-fixed paraffin-embedded) tissue slices of invasive breast cancer. The product utilizes reverse transcription real-time quantitative PCR (RT-qPCR) with Taqman technology to quantitatively detect the mRNA expression levels of the four target genes (ERBB2, ESR1, PGR, and MKI67) and two reference genes. It provides further testing for cases that are difficult to determine through traditional immunohistochemical analysis and for cases where the results of traditional immunohistochemical analysis differ significantly from treatment expectations. This assists in determining the molecular subtypes of breast cancer, improving the accuracy of classification, especially in cases where traditional immunohistochemical analysis may be inconclusive or at variance with treatment expectations.