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]

Core Insights - Shenhe Reform and Innovation Demonstration Zone has achieved a significant milestone with the approval of Shenyang Pengyue Technology Co., Ltd.'s cardiac cryoablation device and disposable sterile cryoablation probe by the National Medical Products Administration, marking a breakthrough in domestic medical devices for cardiac atrial fibrillation treatment [1][2] Group 1: Product Overview - The cardiac cryoablation device is the core of a complete cryoablation system solution, responsible for precise control of refrigerant delivery and recovery, ensuring stability and safety during the ablation process [2] - The disposable sterile cryoablation probe is a key instrument that directly targets the myocardial area, made from special alloy materials, allowing for full-path cardiac ablation treatment with a single probe, significantly reducing treatment costs [2] Group 2: Technological Advancements - The device has achieved domestic technological breakthroughs in refrigerant selection, active rewarming design, probe vacuum insulation, and flexible structure, with its backside temperature feedback technology being an international first [2] - These advancements are expected to disrupt the long-standing dominance of foreign products in the relevant medical field, providing better treatment options for domestic clinicians and patients [2]

Core Viewpoint - The article highlights the recent approval of four innovative medical devices by the National Medical Products Administration in China, indicating a growing trend in the development and registration of innovative medical technologies in the country [1][8]. Group 1: Approved Products - The approved products include: 1. "Extended Depth of Focus Intraocular Lens" by Aibono Medical Technology Co., Ltd. [1] 2. "Cardiac Cryoablation Device" and "Single-use Sterile Cryoablation Probe" by Shenyang Pengyue Technology Co., Ltd. [1][8] 3. "Cross-linked Polyisobutylene Aspheric Intraocular Lens" by Xi'an Yandale Medical Technology Co., Ltd. [1][8] - As of now, a total of 373 innovative medical devices have been registered in China [1]. Group 2: Company Profiles - Aibono Medical Technology Co., Ltd. is an innovative ophthalmic medical device manufacturer listed on the Sci-Tech Innovation Board, focusing on cataract surgery, myopia control, and vision care solutions. The company reported a total revenue of 787 million yuan (approximately $114 million) with a year-on-year growth of 14.72% and a net profit of 213 million yuan (approximately $31 million) with a growth of 2.53% in the first half of 2025 [6]. - Shenyang Pengyue Technology Co., Ltd., established in 2020, specializes in digital intelligent precision medical fields and has developed a cardiac cryoablation system with independent intellectual property rights [10]. - Xi'an Yandale Medical Technology Co., Ltd. focuses on intraocular lenses for cataract treatment and is led by a team of experts, including members from the American Academy of Engineering [18]. Group 3: Product Details - The "Extended Depth of Focus Intraocular Lens" is designed for vision correction after cataract surgery, featuring a one-piece, foldable design made from a combination of ethyl acrylate and methyl methacrylate [5]. - The "Cardiac Cryoablation Device" is used for treating persistent atrial fibrillation in adult patients, utilizing argon gas for rapid cooling of myocardial cells [9]. - The "Cross-linked Polyisobutylene Aspheric Intraocular Lens" is notable for its high refractive index and is designed for implantation through a small incision, providing an improved visual experience for cataract patients [15].