Ambu receives FDA clearance for its sterile, single-use duodenoscope

Ambu receives FDA clearance for its sterile, single-use duodenoscope

Press releases may be edited for formatting or style | July 20, 2020 Endoscopy

Initiating Post-market study

Having obtained FDA clearance, Ambu will initiate a 500-patient post-market study at multiple centers in the U.S. as planned. A sub-set of the study will be made public during Q1 of Ambu’s financial year 2020/21 when data from a minimum of 60 procedures is available.

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Robust innovation product pipeline

Over the next three years, Ambu is introducing 15 new devices across all major areas of endoscopy. This includes three additional devices specifically for GI specialists: a colonoscope, a gastroscope and a cholangioscope.

Built on a decade of experience

Ambu launched the world’s first single-use flexible bronchoscope, the Ambu® aScope in 2009. Ten years later, in 2019, over 600,000 Ambu single-use endoscopes were used in more than 6,000 hospitals making Ambu the world’s largest supplier of single-use endoscopes. The aScope Duodeno was designed with input from a global gastroenterologist consutlant board along with engineering expertise from the team of Invendo Medical acquired by Ambu in 2017.


About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring & diagnostics solutions. The manifestations of our efforts have ranged from early innovations like the Ambu® Bag™ resuscitator and the Ambu® BlueSensor™ electrodes to our newest landmark solutions like the Ambu® aScope™ – the world’s first single-use flexible endoscope. Moreover, we continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on the work of doctors, nurses and paramedics. Headquartered near Copenhagen in Denmark, Ambu employs approximately 3,500 people in Europe, North America and the Asia Pacific.

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