Ambu receives 510(k) clearance for single-use endoscope for GI conditions

Ambu Inc. announced it received FDA 510(k) clearance for the Ambu aScope Duodeno.“At Ambu, we are determined to advance patient safety through innovative design of single-use devices, and we are excited to improve safety for the 2 million patients each year who require an ERCP (Endoscopic Retrograde Cholangio-Pancreatography) procedure,” Juan Jose Gonzalez, CEO of Ambu A/S, based in Copenhagen, Denmark, said in the release. “It’s no longer necessary to balance the necessity of the procedure against the risk of infection from a reusable endoscope. Now, both doctor andRead More

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