Ambu scores FDA clearance for single-use gastroscope and touchscreen display

Though sustainability concerns usually make recyclable materials preferable to one-and-done options, when it comes to surgical devices, there’s an invaluable peace of mind and sense of safety that comes with single-use, individually sterilized tools.

That—plus the elimination of reprocessing material needs, intensive re-sterilization procedures and wait times for repairs—is the thinking behind Ambu’s collection of disposable endoscopes. They come individually packaged and already sterilized, ready to be connected to a facility’s surgical system for immediate use.

The latest additions to Ambu’s slate are a single-use gastroscope and a display monitor to view endoscope camera feeds, both of which are newly cleared by the FDA.

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The aScope Gastro’s FDA clearance introduces Ambu into the gastroscopy market, comprising approximately 20 million procedures per year to examine a patient’s esophagus, stomach and duodenum.

The disposable scope is designed to be lightweight and comfortable to hold and to connect to most standard endoscopy equipment. It features an auxiliary water jet channel and a camera tip equipped with two LED lights and a 140° view.

The aScope Gastro can be connected to aBox 2, Ambu’s newly launched real-time imaging unit. It displays an endoscope’s camera feed in high definition, with adjustable color, contrast and brightness settings to ensure surgeons are seeing the most accurate picture.

The aBox 2 is controlled by a touchscreen, allowing surgical teams to zoom in and out of camera views, begin recording video or taking a photo, adjust display settings and track the surgical to-do list, all with a simple tap on the screen.

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The regulatory nods for the two products follow those for a handful of the Danish devicemaker’s other single-use endoscopes. In 2021 alone, the FDA cleared the aScope 4 Broncho Sampler Set, which combines a disposable bronchoscope and specimen collection tool, as well as the latest edition of Ambu’s VivaSight camera-equipped airway tube.

Outside of the U.S., Ambu snagged European CE mark approval for the new VivaSight device and its single-use duodenoscope, aScope Duodeno, and Health Canada clearance for its aScope 4 Cysto disposable cystoscope, used in urological procedures.