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

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

EndoFresh reports 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.

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 anytime 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.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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