最新！2款创新器械获批上市！

Core Insights - The National Medical Products Administration (NMPA) has approved two innovative medical devices: the AI-Rad Companion™ Prostate MR software by Siemens Medical and the G-Branch™ thoracoabdominal aortic stent system by Xianjian Technology, marking a significant advancement in China's medical device industry from "catching up" to "leading" [2][19][27]. Group 1: G-Branch™ Thoracoabdominal Aortic Stent System - The G-Branch™ system is designed for complex vascular conditions, specifically targeting thoracoabdominal aortic aneurysms (TAAA) and thoracoabdominal aortic dissections (TADA), providing a minimally invasive repair solution [7][8]. - This system includes five components: main stent, peripheral stent, extension stent, bifurcated main stent, and iliac extension stent, ensuring safety and effectiveness during surgery [7][12]. - The G-Branch™ system features a unique "dual inner and dual outer" hybrid branch design, which mimics the natural taper of the thoracoabdominal aorta, significantly reducing risks associated with traditional systems [8][9]. - Clinical studies demonstrated a 99.7% success rate in branch reconstruction and a 98.6% overall survival rate, indicating the system's reliability in real-world applications [13]. Group 2: AI-Rad Companion™ Prostate MR Software - The AI-Rad Companion™ Prostate MR software is a localized version of Siemens' global AI-Rad Companion family, designed to assist in the analysis of multiparametric MRI for suspected prostate cancer in men aged 40 and above [19][20]. - This software aims to improve diagnostic accuracy and reduce unnecessary biopsies, with a negative predictive value exceeding 95%, potentially avoiding 20-30% of negative biopsies [20][24]. - The software consists of two main modules: a confirmation module for image loading and patient verification, and a settings module that integrates deep learning for prostate configuration and lesion detection [23]. - Clinical trials showed a sensitivity of 92% and specificity of 88%, with the software enhancing cancer detection rates by 18% and reducing report generation time significantly [24][25]. Group 3: Company Profiles - Xianjian Technology, founded in 2003, is a leading Chinese company in cardiovascular and peripheral vascular intervention medical devices, with a market capitalization exceeding 10 billion HKD [14][16]. - Siemens Medical, a subsidiary of Siemens Healthineers, has been operating in China for over 20 years and plans to launch 20 "China-made" products in 2025, reinforcing its commitment to local innovation [27].