EndoFresh® Secures NMPA Approval for Its Innovative Single-Use Electronic Colonoscope – Pioneering China’s Leadership in Global Disposable GI Endoscopy
On May 26, 2022, Xianzan Technology independently developed EndoFresh®Disposable electronic colonoscope approved for market launch; clinical trials have been completed at more than ten Grade A tertiary hospitals across China, including Beijing Friendship Hospital, Shanghai Zhongshan Hospital, Wuhan Union Hospital, Wuhan Zhongnan Hospital, Nanfang Hospital of Southern Medical University, and Shenzhen Hospital of Southern Medical University, among other renowned Grade A tertiary hospitals in China. This EndoFresh®Disposable electronic colonoscope approved for market launch, following Xianzan Technology’s EndoFresh, which had previously received NMPA certification®XZING-S2 Electronic Endoscope Image Processor, EndoFresh®Together with the disposable electronic gastroscope, it forms Xianzan Technology’s proprietary disposable electronic digestive endoscopy system, covering both the upper and lower gastrointestinal tracts. This is also the world’s first disposable electronic digestive endoscopy system to have obtained CE, FDA, and NMPA registrations simultaneously, marking that China-made innovative disposable digestive endoscopes are at the global forefront.
According to Frost & Sullivan, the global medical endoscopy market was valued at USD 20.3 billion in 2020, with China accounting for 16.5% of the market, equivalent to approximately RMB 22.4 billion. The “Research Report on Segmented Market Demand and Development Opportunities in China’s Disposable Endoscope Industry (2021–2026),” released by Xin Si Jie Industrial Research Center, indicates that China’s disposable endoscope industry is currently in its early stages of development. Driven by the rapid overall growth of the domestic healthcare sector, demand for disposable endoscopes is rising swiftly, and the market size is projected to exceed RMB 9 billion by 2030.
Currently, single-use endoscopes have been applied in multiple fields. For instance, in the respiratory field, companies such as New Guangwei and Pusheng Medical are active; in the urological field, Ruipai Medical and Xingfu Gongchang (Happy Factory) are notable players. However, due to their more complex structures, higher manufacturing process requirements, and cost considerations, few single-use electronic gastroscope/colonoscope products have been introduced into clinical practice, leaving a significant clinical gap. Particularly since the onset of the pandemic, the gastrointestinal endoscopy sector has faced stricter infection prevention and control requirements. There is an urgent need among patients and healthcare professionals for new products and solutions to support endoscopic diagnosis and treatment under pandemic conditions. In response, numerous domestic experts have issued relevant guidelines early on, clearly highlighting the clinical value of single-use endoscopes.
EndoFresh®Officially developed in 2015, with a deep focus on the gastrointestinal (GI) field. After years of research and development, the EndoFresh® disposable electronic gastrointestinal endoscopy system received CE certification in December 2017 and FDA clearance in September 2020. In August 2021, the XZING-S2 electronic endoscope image processor obtained NMPA certification, followed by NMPA certification for the EndoFresh® disposable electronic gastroscope in March 2022.
Following the FDA and CE certifications of its single-use electronic gastrointestinal endoscopy system, EndoFresh®Clinical studies have been progressively conducted in China. Following approval by the National Medical Products Administration (NMPA), EndoFresh® has successively initiated clinical application explorations with multiple core tertiary Grade A hospitals across the country, while simultaneously exploring various diagnostic and therapeutic scenarios, including emergency/bedside use and combined dual-endoscopy procedures. The manuscript detailing the registrational clinical study conducted in collaboration with Beijing Friendship Hospital was published in the journal Gastrointestinal Endoscopy (GIE) in April 2022.For detailed coverage, please click: New Chapter in GIE Research—The World’s Largest Clinical Study on Single-Use Digestive Endoscopes: A Prospective, Randomized, Non-Inferiority Trial Comparing Single-Use and Reusable Electronic Gastroscopes）
Following the application of EndoFresh by experts at the 2021 Southern Digestive Diseases and Digestive Endoscopy International Forum,®Following demonstrations of routine gastrointestinal endoscopy, polypectomy, and internal hemorrhoid ligation using the disposable electronic endoscope system, Nanfang Hospital of Southern Medical University has expanded its application into emergency care. The hospital has successfully performed more than 40 such procedures, including foreign body removal and management of gastrointestinal bleeding, with related research articles scheduled for publication in the near future.
2021 Southern International Forum on Digestive Diseases and Digestive EndoscopyLive Broadcast Site
Disposable Electronic Digestive Endoscopy for Emergency Foreign Body Removal
EndoFresh during the 2022 Egyptian Digestive Disease Week (EDDW)®At Wuhan Zhongnan Hospital, Director Wang conducted a live broadcast of gastric polyp resection and internal hemorrhoid ligation procedures. Domestic and international experts in attendance unanimously affirmed the product’s value and expressed significant interest. (For detailed event coverage, please refer toThe New Era of Endoscopic Diagnosis and Treatment—Endofresh®Disposable Electronic Gastroscope Debuts at EDDW）
Wuhan EDDW Live Broadcast
Recently, as a domestically developed innovative product, EndoFresh®Already exported overseas and adopted for clinical diagnosis and treatment by large public healthcare groups in France and other regions. It is hoped that with the export of domestically produced innovative products, EndoFresh®It will serve as a bridge connecting experts in the field of gastroenterology from China and abroad.
With the proposal of the "Outline of the 'Healthy China 2030' Plan," EndoFresh®Disposable digestive endoscopes will become an important complement to diagnosis and treatment in the field of gastroenterology. With their portability, ease of use, low initial acquisition cost, and broad applicability, they meet the needs of primary healthcare settings and contribute to filling current gaps in medical services.
EndoFresh®Disposable electronic gastroscope/colonoscope is supplied in sterile packaging. Upon opening the package, simply connect the device to the S2 electronic endoscopy image processor for immediate use, ensuring convenience and safety. It features a 3.00 mm instrument channel compatible with various therapeutic instruments. The product received NMPA certification in March and May 2022, respectively. Product advantages include:
(1) Capable of delivering 2K high-definition visuals with true-to-life color reproduction;
(2) Use immediately after unpacking to avoid performance degradation caused by mechanical property changes and component corrosion;
(3) Single-use design eliminates the need for cleaning and sterilization, avoiding additional costs for cleaning, maintenance, and repairs.
(4) Portable and flexible, easy to use, simple to install, adaptable to various medical scenarios such as clinical diagnosis and treatment, emergency/bedside care, and combined endoscopic procedures.
