Core Viewpoint - Ambu's aScope 5 Cysto HD has received FDA approval for use in percutaneous nephrolithotomy (PCNL), marking a significant advancement in the application of disposable endoscopes in complex urological surgeries, enhancing the platform's capabilities in minimally invasive procedures [2][15]. Product Development and Features - The aScope 5 Cysto HD is a high-resolution, bidirectional flexible endoscope designed initially for bladder examinations and ureteral observations, now expanded to include kidney stone surgeries [3][14]. - The endoscope has a diameter between 4.8 to 5.4 mm, with a tip deflection of up to 210°, and features a CMOS image sensor supporting 1080p HD imaging, providing superior visualization in complex anatomical areas [5][15]. - The single-use nature of the aScope 5 Cysto HD significantly reduces the risk of cross-contamination and simplifies the preparation and cleaning processes compared to traditional reusable endoscopes [5][15]. Clinical Application and Advantages - In PCNL procedures, the aScope 5 Cysto HD can assist in stone localization, enhance stone fragmentation efficiency, and confirm the absence of residual stones post-surgery [10][11]. - The system supports dual visualization by integrating with Ambu's aScope 5 Uretero, allowing simultaneous display and control of two endoscopes, which saves time and reduces anesthesia exposure during surgery [9][10]. Market Position and Strategy - Ambu holds over 50% market share in the global disposable endoscope market, with its aScope series utilized in over 8,000 medical institutions [12]. - The company’s strategy focuses on a "procedure-oriented + platform synergy" approach, differentiating itself from traditional reusable endoscope manufacturers [12][16]. Future Outlook - Ambu plans to initiate larger-scale clinical trials in 2026 to further validate the aScope 5 Cysto HD's adaptability and long-term efficacy across various patient demographics and surgical complexities [13]. - The company is also exploring the expansion of its aScope platform into gastroenterology and respiratory fields, aiming for multidisciplinary collaboration and integration of advanced features like 4K imaging and AI navigation [13][16].