The FDA has given 510(k) regulatory clearance to a new sterile, single-use scope, the first from Ambu. Called aScope Gastro, the scope is used alongside the company’s aBox 2 system.

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The aScope Gastro is a single-use scope, which is used with the aBox 2 system. Photo credit: Ambu.

The aScope Gastro offers a distal tip with two LED lights and a 140-degree field of view with a 3- to 100-mm depth of field, according to company specifications. The lightweight device is also flexible, with up to 210 degrees of retroflexion, along with the ability to turn 90 degrees down, 100 degrees to the right and 100 degrees to the left.

The camera sensitivity has four times higher resolution than the aScope 4 model, the company said. The scope has an average selling price of $350, and the compatible display platform runs about $7,500, according to a company investor presentation, and will be available for purchase this spring. 

 

—GEN Staff