China’s National Medical Products Administration (NMPA) has granted marketing approval for two new medical devices: Synaptic Medical’s cryoablation device and Wuhan Kadwise Biotechnology Co., Ltd’s human CDO1/AJAP1/GALR1 gene methylation detection kit (fluorescence PCR method). These approvals highlight advancements in treating atrial fibrillation and diagnosing endometrial cancer.
Cryoablation Device for Atrial Fibrillation
Synaptic Medical’s cryoablation device is designed to treat drug-resistant, recurrent, and symptomatic paroxysmal atrial fibrillation in adult patients. The device effectively reduces the risk of balloon bouncing and displacement caused by pressure fluctuations during pulmonary vein occlusion and ablation. This innovation enhances procedural safety and efficacy, addressing a significant clinical need in cardiovascular medicine.
Gene Methylation Detection Kit for Endometrial Cancer
Wuhan Kadwise Biotechnology’s CDO1/AJAP1/GALR1 gene methylation detection kit is intended for use as an auxiliary diagnostic tool for suspected endometrial cancer patients. By identifying specific gene methylation patterns, the kit aids in the early detection and diagnosis of endometrial cancer, contributing to improved patient outcomes and survival rates. This approval underscores the growing importance of molecular diagnostics in oncology.-Fineline Info & Tech
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