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

What Kind of Equipment is Used to Analyze DNA?

Below are some of a few basic processes followed throughout DNA testing. The general procedure entails:  • Isolating DNA from a sample containing the needed...

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

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.

spot_img

DON'T MISS

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles