EndoFresh Obtains FDA 510(k) Clearance for Its Groundbreaking Disposable Digestive Endoscopy System

EndoFresh reveals its novel Disposable Digestive Endoscopy System with full advantages of potential clinical application, patient safety and financial implication, which is approved by the FDA and CE. It is perfect for gastrointestinal endoscopy, effectively helping physicians in ICU, ER, outpatient clinic, GI suite and bed-side treatment, especially during post-pandemic era.

EndoFresh Disposable GI Endoscope and Colonoscope

The FDA has greenlighted EndoFresh Disposable Digestive Endoscopy System, following years of reports of persistent cross-contamination issues being transmitted among multi-patients by the notoriously difficult-to-clean devices and efforts earlier this year to urge the industry to transform devices into safer design without reprocessing. EndoFresh Disposable Digestive Endoscopy System features a camera system with innovative all-in-one design, disposable upper GI endoscope and disposable colonoscope, which are used together with the medical display and other peripheral devices to allow physicians to visualize, diagnose and operate gastrointestinal endoscopy.

Recently, the FDA has alerted health care providers to the risk of infections associated with reprocessed urological endoscopes, citing over 450 medical device reports since 2017, describing post-procedure patient infections or other possible contamination. According to the agency statement, the problems identified with reprocessed urological endoscopes and duodenoscopes may apply to similar devices. Therefore, the FDA has also been reviewing information on other types of reusable endoscopes.

Since the global flexible endoscope market blossoming for safety and effectiveness, many manufacturers have engaged in the R&D of disposable endoscope. EndoFresh's industry-pioneering technology addresses the traditional challenge of expanding endoscopy procedures, while ensuring its single-use devices are cost-effective, risk-controllable and accessible. "With this novel system, medical practitioners could offer patients a secure experience, which is available at any time and anywhere. It helps to prevent the risk of cross-infection and minimize the workload in preoperative screening and postoperative disinfection," said EndoFresh CEO, Dr.Lee.

Compared with high acquisition and repair expenses, spending on washing equipment and cleaning personnel as well as multiple points of failure associated with improper high-level disinfection practices of reusable endoscope, the risk factor of disposable endoscope is much lower or even negligible. EndoFresh differentiates its devices from traditional reprocessing and time-consuming maintenance solutions, while also adhering to strict reliability and first-class quality standards and adapting to the fast-growing market demands for innovation and possessing greater potential to generate actual benefits in the near future.

About EndoFresh

Established in 2014, EndoFresh is a Chinese high-tech medical device manufacturing enterprise engaged in R&D and manufacture of high-end disposable digestive endoscopes.Headquartered in Shenzhen Science Park, one of the most dynamic innovation centers in China, EndoFresh independent R & D products have obtained over 200 patents. Moreover, the company is manufactured in compliance with the ISO 13485 certificate. EndoFresh are dedicated to make every endoscopy no-delay, risk-free and cost-effective process.

For more information, please visit www.endofresh.com

Source: EndoFresh

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Categories: Gastroenterology/Intestinal Diseases

Tags: Colonoscope, Disposable, endoscopy, FDA, FDA 510k Clearance, Gastroenterology, Gastroscope, medical, Single-use


About EndoFresh

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Inventor and manufacturer of medical disposable flexible endoscopes.