肿瘤电场治疗仪获批上市

Core Viewpoint - The National Medical Products Administration has approved the registration application for a tumor electric field therapy device developed by Hunan Antai Kangcheng Biotechnology Co., Ltd, marking the first domestic product for treating this rare disease [1] Group 1: Product Details - The device consists of a main unit, distribution box, disposable electrode pads, power adapter, lithium-ion battery, and charging dock [1] - It generates a fixed frequency alternating electric field targeting the brain, suitable for patients aged 22 and above diagnosed with supratentorial glioblastoma through histopathological or imaging methods [1] - The product is intended for use in conjunction with temozolomide (TMZ) after surgical and radiotherapy treatments [1] Group 2: Market Impact - This product is expected to enhance the accessibility of treatment for patients suffering from this rare condition [1] - The regulatory authority will strengthen post-market supervision of the product to ensure patient safety [1]