Danish medtech company receives FDA approval for disposable colonoscope

January 09, 2018
HQ-building_imagebank_high (1) Photo by Ambu A/S
The U.S. Food and Drug Administration (FDA) approves the disposable colonoscope by Danish company, Ambu, for use in the US.

Danish medtech company, Ambu, receives FDA clearance for its disposable colonoscopes, which will be addressed to the +15 million annual procedure market for colonoscopy in the US.

The disposable colonoscope is sterile straight from the pack and thereby eliminates the risk of device-related infections and it improves hospital workflows.

We are very pleased with the approval by the FDA, which we see as a clear signal that there is a need for mitigating the risks of cross-contamination within endoscopy, a risk that was recently ranked as the 2nd most critical health hazard in ECRI’s report for 2018.The FDA approval marks a positive upgrade of our business potential” says Lars Marcher, CEO of Ambu, according to a press release.

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