Ambu Receives FDA Clearance for its Sterile, Single-use Duodenoscope
The Ambu aScope Duodeno received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on 17 July 2020 and is now ready for commercial launch as planned.
“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 two million patients each year, who need an ERCP procedure,” says Juan Jose Gonzalez, CEO of Ambu. “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.”
Reusable duodenoscopes have been under increasing critique from FDA in recent years because there have been cases of device-related infections and patient fatalities. In August 2019, FDA recommended duodenoscope manufacturers and health care facilities to transition to duodenoscopes that are partially or completely single-use.
“The aScope Duodeno is sterile, seamlessly integrates into existing hospital systems and offers an intuitive, lightweight design with similar functionality to reusable duodenoscopes,” says Greg Swanson, SVP, Chief Marketing Officer at Ambu. “Over the past six 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.”
Neha writes articles on sectors including medicine, food, materials, and science & technology. A qualified statistician, she has the ability to observe and analyze the trends in global markets and write compelling articles that help CXOs in decision making. She is a bookworm and loves to read fiction, lifestyle, science and technology. Neha comes with 6 years of experience in content writing and editing that involves blog writing, preparation of study materials and OERs.