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 and patient can focus on diagnosis and treatment by using a sterile, single-use duodenoscope.”
According to the release, the duodenoscope solution includes the single-use endoscope, Ambu aScope Duodeno and Ambu aBox Duodeno, a reusable processor unit. Both devices are covered under FDA clearance. It is intended to be used to examine the duodenum and aid in the diagnosis and treatment of conditions like gallstones, pancreatitis, tumors or cancer in the bile ducts or the pancreas.
“The aScope Duodeno is sterile, single-use and seamlessly integrates into existing hospital systems and offers an intuitive, lightweight design with similar functionality to reusable duodenoscopes,” Jens Kemp, vice president of marketing at Ambu Inc, said in the release. “Over the past 6 months, we have expanded our sales organization and built a dedicated commercial infrastructure for gastroenterology. After today’s FDA clearance, we will now approach our customers to arrange product demonstrations, set up evaluations and promote what Ambu has to offer within the field of GI.”