Vice president unit of CAMDI, SonoScape’s high-definition endoscope has successfully obtained FDA certification

  • 2018-09-16

With the popularization of endoscopic minimally invasive techniques and the improvement of endoscopic manufacturing technology, endoscope has been applied to gastroenterology, respiratory, general surgery, otolaryngology, orthopedics, urinary surgery, gynecology departments, etc., becoming an indispensable medical diagnostic and surgical device and one of the fastest growing products in the global medical device industry. As the global endoscope industry has grown rapidly in recent years, its demand for high definition and more clinically targeted products is high. The domestic HD-500 endoscope system, recently launched by SonoScape, has obtained the FDA certification. It’s a key step for entering the US and related markets.

China’s endoscopes are widely welcomed by the international market because of their excellent technical quality and high cost performance, while the most representative one is SonoScape endoscope. Domestic HD digestive endoscopy demonstration bases have been settled after strict controlled screening. At present, a large number of selected top three hospitals have evaluated the performance of domestic endoscopes by the actual clinical use of SonoScape HD-500, and actively proposed improvement suggestions. At the same time, they use SonoScape HD-500 to carry out basic training and promote advanced medical treatment techniques to the surrounding areas.

HD-500, with 1080P high-definition CMOS imaging, can efficiently and accurately find lesions with VIST dyeing technology; large bending angle without external force to pull the lens reduces visual blind zone; attached water delivery apparatus for full series ensures clear vision and timely detection of bleeding points; 500G large memory independent Workstation, USB and DICOM interface, instant image storage and output, diagnostic report, etc., make clinical communication more convenient.

At present, very small number of national enterprises are able to manufacture high-definition endoscopes, and previous domestic HD endoscopes have not passed the FDA certification, making China’s high-definition endoscopes occupy no place in the market of the United States, the largest developed country. In such a “blue ocean market”, SonoScape has passed the FDA certification with years of research and development technology accumulation and strategic layout, and opened the door of China’s endoscopes entering the US and related markets.