Ambu receives FDA approval for gastroscope
It is the first single-use gastroscope to be cleared by the FDA, according to Ambu.
by MARKETWIRE
Ambu has received approval from the US Food and Drug Administration for its single-use Ascope Gastro Large gastroscope.
It is the first single-use gastroscope to be approved by the FDA, Ambu says.
The approval will give surgeons and physicians a broader selection for examinations in the gastrointestinal tract, among other areas. The portfolio also includes Ascope Gastro.
Ambu has a target of 1.5 million procedures worldwide with Ascope Gastro Large and a target of 2 million per year for Ascope Gastro.
Ascope Gastro Large was approved by European authorities in September 2023.
Translated using DeepL with additional editing by Kristoffer Grønbæk
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