Ambu has obtained 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its new-generation duodenoscopy solution, the aScope Duodeno 2 and aBox 2, which is designed for endoscopic retrograde cholangiopancreatography (ERCP) procedures.
The aScope Duodeno 2 solution is aimed at meeting the high-performance expectations in ERCP and addressing the complex reprocessing challenges currently faced by healthcare providers.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The aScope Duodeno 2 and aBox 2 are engineered to meet the requirements of gastroenterologists performing ERCP, a complex and often physically demanding procedure.
Ambu’s collaboration with experienced gastroenterology professionals and ERCP specialists has led to enhancements in critical performance factors and seamless integration with the aBox 2 endoscopy system.
The aScope Duodeno 2 is a fully sterile, single-use solution, aligning with FDA safety recommendations of 2019 and 2022 to transition towards partially or completely single-use duodenoscopes.
The improved ergonomics of aScope Duodeno 2 also aim to reduce strain on endoscopists during lengthy procedures.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataAmbu is planning to incorporate bioplastic materials into the handle of the new generation aScope Duodeno 2 solution over time.
An extended controlled market release with key hospitals is planned to evaluate the clinical performance of the aScope Duodeno 2 in real-life settings.
The solution is expected to be available in the market from 2024/2025, and the recent FDA clearance will not impact Ambu’s financial guidance for 2023/2024.
Ambu CEO Britt Meelby Jensen said: “Our new-generation duodenoscope solution is a result of a close partnership with gastroenterologists. Based on their feedback, we have developed a solution to meet the distinct procedural needs in ERCP.
“We are dedicated to continuing Ambu’s focused journey within GI, anchored in profound customer understanding as a pivotal driver for unlocking long-term potential – for gastroenterologists, patients and Ambu.”
Earlier this month, the company also secured FDA 510(k) clearance for its therapeutic gastroscope solution, the aScope Gastro Large and aBox 2.
With a 4.2mm working channel and powerful suction performance, aScope Gastro Large is designed to meet acute therapeutic procedure requirements in the ICU, including bleed management and food impaction.
