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Home » FDA clears Ambu’s single-use gastroscope and next-gen display unit

FDA clears Ambu’s single-use gastroscope and next-gen display unit

February 4, 2022 By Sean Whooley

Ambu aScope Gastro
[Image from Ambu]
Ambu announced today that it received FDA 510(k) clearance for its Ambu aScope Gastro and Ambu aBox 2 platforms.

Ballerup, Denmark–based Ambu designed the aScope Gastro as its first sterile, single-use gastroscope with new advanced imaging and design features in a combined offering with next-generation display and processor technology. The aBox 2 includes HD capabilities to improve image quality at the heart of Ambu’s endoscopy ecosystem.

According to a news release, the launch of the aScope Gastro platform allows Ambu to enter into the gastroscopy segment with a single-use scope, offering advanced technology, portability and cost-effectiveness compared to the reusable endoscopes that dominate the space.

The company said aScope Gastro will support healthcare systems in reducing waiting lists and overcoming staff shortages, too, amid issues that have persisted since the COVID-19 pandemic began. It also provides a solution to cross-contamination risks, particularly in vulnerable patients, Ambu added.

Ambu plans to follow the FDA clearance by proceeding straight away with commercialization for the aScope Gastro and aBox 2 in the U.S.

“Gastroscopy is not only one of the largest segments in endoscopy, but also has all the conditions to benefit from single-use endoscopy. There is a clear need for more convenience, flexibility, and infection control, which are all addressed with the introduction of our aScope Gastro,” Ambu CEO Juan Jose Gonzalez said in the release. “The technology in our aScope Gastro and aBox 2 will set a new benchmark in terms of image quality and functionality and will power all of our next-generation launches. Our expansion within GI will extend Ambu’s position as the world’s most innovative single-use endoscopy player.”

Filed Under: 510(k), Business/Financial News, Endoscopic, Featured, Food & Drug Administration (FDA), Imaging, News Well, Regulatory/Compliance, Surgical Tagged With: Ambu, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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