医疗器械创新种子加速落地开花

Core Points - The article highlights the approval of two innovative medical devices by Pengyue Technology, specifically a cardiac cryoablation device and a disposable sterile cryoablation probe, which are recognized as national-level innovative medical devices [1][2] - The provincial drug regulatory authority has been actively supporting the innovation of medical devices, optimizing the review and approval processes to accelerate the transformation of innovative results [2][3] - The new cardiac cryoablation system is expected to provide a safer, more efficient, and controllable treatment option for patients with persistent atrial fibrillation, with clinical trial results showing an 80% effectiveness rate in preventing recurrence six months post-surgery [2][3] Company Summary - Pengyue Technology has successfully developed a cardiac cryoablation system that addresses the limitations of traditional treatment methods and significantly reduces patient treatment costs [3] - The company formed a collaborative team to apply argon-helium cryogenic technology to surgical treatments, overcoming challenges related to cooling speed and rewarming processes [2] - The new products are set to be applied clinically in December, marking a significant advancement in the medical device industry [3] Industry Summary - The medical device industry in China is experiencing rapid growth, with the market size surpassing one trillion yuan [3] - The provincial drug regulatory authority plans to deepen reforms in drug regulation and support high-quality development in the pharmaceutical industry, aiming to benefit more companies from the regulatory changes [3]