EndoFresh® Launches Four Single-Use Gastrointestinal Endoscopes, Expanding Minimally Invasive Care Across Diverse Clinical Settings

Recently, EndoFresh^®(endofresh) announced that its four single-use digestive endoscopes have officially received NMPA registration certificates, highlighting its capability for continuous iteration aligned with clinical needs in the field of single-use digestive endoscopy, and ushering in a new chapter for single-use flexible endoscopes in multi-scenario, multi-procedure, and more portable minimally invasive diagnosis and treatment.

EndoFresh^®Disposable Digestive Endoscope

The concept of single-use endoscopes can be traced back to 2009, when the Danish company Ambu pioneered such products. However, it was not until 2015, after the U.S. Food and Drug Administration (FDA) identified that Olympus’s reusable endoscopes were difficult to thoroughly disinfect and posed a potential risk for superbug outbreaks, that single-use endoscopes began to garner increasing attention.

From 2016 to 2019, the challenges of endoscope disinfection and the resulting cross-infection risks were listed for four consecutive years in the Top 10 Health Technology Hazards report published by the ECRI Institute. To mitigate the risk of cross-infection, demand for disposable endoscopes is on the rise. According to data from the National Medical Products Administration (NMPA), as of December 2024, more than 80 manufacturers had obtained registration certificates for disposable endoscope products. Among them, over 50 manufacturers hold certifications for disposable ureteroscopes or cystoscopes, nearly 20 for disposable bronchoscopes, and more than 10 for disposable hysteroscopes. Disposable endoscopes are gradually becoming a significant segment of the endoscopy market, offering broad market prospects and growth potential.

In the gastrointestinal endoscopy segment, which sees the highest number of endoscopic examinations, the high product complexity and significant variations in clinical needs have resulted in a limited number of participants. Currently, the only fully disposable single-use gastrointestinal endoscopes available on the market that comply with U.S. FDA infection control requirements are those from Denmark’s Ambu and China’s EndoFresh.^®disposable gastrointestinal endoscopes, as well as the disposable duodenoscope developed by Boston Scientific (USA) for ERCP procedures, while EndoFresh^®(Endofresh) is among the first disposable digestive endoscope products in China to obtain NMPA registration certificates through the special approval process for innovative medical devices.

EndoFresh^®(endofresh) is the world’s first disposable digestive endoscope product to simultaneously obtain CE certification from the European Union, FDA clearance from the United States, and NMPA approval from China. Adhering consistently to independent innovation in core technologies, it has established a fully self-developed core technology platform and an autonomous, controllable component supply chain. It has successfully developed disposable digestive endoscopes in various specifications to meet clinical needs across different procedures and scenarios. As a complement to traditional endoscopes, it offers a new solution and option for patients with special infectious diseases, immunocompromised or immunodeficient individuals, and surgical procedures requiring strict sterility.

EndoFresh^®(Endofresh) Developed a variety of endoscope specifications to meet the needs of specific surgical procedures, based on clinical and differentiated scenario requirements.

Among the four endoscope models approved in this batch, the 210° wide-angle view facilitates ESD procedures targeting areas such as the cardia and gastric fundus, making the treatment of lesions in difficult-to-reach locations more manageable. The specialized 900 mm therapeutic endoscope allows physicians greater maneuverability during specific procedures, such as the treatment of esophageal varices or rubber band ligation for internal hemorrhoids, thereby enhancing procedural ease. With a maximum instrument channel diameter of 4.2 mm, the device is compatible not only with standard endoscopic therapeutic instruments (such as hemostatic forceps, injection needles, and foreign body forceps) but also with emerging consumables available on the market, including gastric flow diversion stents, REVITA catheters, and radiofrequency ablation catheters. This high level of compatibility ensures efficient negative-pressure suction during procedures, significantly expanding the scope of applications for disposable endoscopes. Consequently, these endoscopes hold broad prospects in routine endoscopic examination and therapy, minimally invasive surgery, and weight management, providing clinicians with more minimally invasive and convenient sterile endoscopic diagnostic and therapeutic solutions.

EndoFresh^®Portable Endoscopy Console (GEC-2000P) is the world’s first electronic endoscopic image processor to integrate air/water supply, auxiliary water jet, suction, light source, display screen, and workstation functionalities into a single unit. It truly achieves all-in-one integration, requiring no installation and enabling immediate portability. This innovation breaks through the traditional limitation that gastrointestinal endoscopy procedures can only be performed in endoscopy centers, offering unique advantages in special scenarios such as intraoperative surgery, emergency departments/ICUs, field combat readiness, mobile hospitals, disaster relief, and infectious disease wards, thereby significantly enhancing the penetration and accessibility of gastrointestinal endoscopy.

Global Leader: EndoFresh^®Portable Endoscopy System (GEC-2000P)

Currently, reusable endoscopic diagnosis and treatment systems suffer from pain points such as high acquisition costs, complex reprocessing procedures, and high post-purchase maintenance and repair costs, while EndoFresh^®Portable endoscopy solutions reduce hospitals’ initial capital outlay and subsequent reprocessing and maintenance costs. With features such as lightweight design, portability, and elimination of reprocessing, they are better suited for specialized diagnostic and therapeutic needs outside traditional endoscopy centers and can be rapidly deployed in response to public health emergencies.

EndoFresh^®Advantages

As of now, EndoFresh^®Nearly 20 related research papers have been published in top-tier journals both domestically and internationally, providing robust evidence-based support for EndoFresh.^®...has laid a solid foundation for its clinical application. Extensive rigorous clinical studies and real-world data from over 2,000 cases have successfully validated the product’s safety and efficacy. Meanwhile, in-depth collaborations with medical institutions and peer manufacturers of endoscopic consumables will continue to broaden the product’s clinical applications and market acceptance.

Not only that, EndoFresh^®The company has also continued to deepen its engagement and amplify its voice in academic development and market activities. As early as May 2021, dozens of Chinese gastroenterology experts convened online at DDW 2021 to share their experiences with Endofresh endoscopes during the pandemic, present results from relevant clinical controlled studies, and discuss opportunities for further development in clinical practice. In 2024, EndoFresh^®Made prominent appearances at more than ten domestic and international academic conferences, including: DDW 2024, the largest and most academically prestigious conference in the field of digestive diseases worldwide; ENDO 2024, the International Academic Annual Meeting of the World Endoscopy Organization; CGHC 2024, the Annual Conference of the Digestive Physicians Branch of the Chinese Medical Doctor Association; and UEGW 2024, Europe’s largest and most influential academic conference in the field of gastroenterology.

In early November, the Single-Use Digestive Endoscopy Training Center was successfully held during the 2024 Annual Meeting of the Chinese Society of Digestive Endoscopology (CCDE 2024). It provided hands-on practice opportunities for each participant, enabling young physicians to learn and master digestive endoscopy operational techniques, and received widespread and professional acclaim. EndoFresh^®Always adhere to clinical needs as the guide, emphasize academic development, deeply explore the clinical value of products, and benefit more patients.

Selected Booth Collection

EndoFresh: Committed to Becoming the Global Leader in Innovative Flexible Endoscopes^®(EndoFresh) places high importance on its international product strategy. After obtaining EU CE certification in 2017 and U.S. FDA approval in 2020, the company was impacted by the three-year pandemic; this year also marks EndoFresh’s^®In its inaugural year of global expansion, the company fully demonstrated the broad demand for single-use digestive endoscopes by participating in major international academic conferences. This also facilitated academic exchanges with numerous experts and scholars both domestically and internationally, and established strong connections with industry peers, laying a solid foundation for internationalization. To date, channel development has been completed in nearly 30 countries or regions across Europe, Asia-Pacific, and the Middle East and Africa.

In recent years, China has attached great importance to the development of the medical device industry, introducing a series of policies to support innovation and promote domestic substitution, thereby accelerating the R&D and commercialization of medical devices. EndoFresh, a fully original Chinese-developed product with the designation of an innovative medical device,^®, and has also gained access to green channels in certain provinces, accelerating the overall pace of market entry.

As a representative of new quality productive forces and a vice-chairman unit of the Shenzhen Quality Association, EndoFresh^®We place great emphasis on quality and the development of systematic capabilities, having established a supply chain management system that spans from raw materials to finished goods, as well as an end-to-end quality management system covering product R&D and design, quality inspection and testing, after-sales service, and customer feedback. This ensures product consistency and reliability, while continuously enhancing product quality and customer satisfaction.

With the approval of multiple products, the company will further intensify its marketing efforts, leveraging precise market positioning and brand strategy to continuously consolidate its global leadership in the disposable digestive endoscopy market. Built on a foundation of R&D innovation and quality, EndoFresh^®We will continue to uphold our patient-centric philosophy, collaborate with healthcare professionals worldwide, and continuously optimize our products and services to support the advancement of global healthcare.