A single-use gastroscope has received 510(k) clearance from the U.S. Food and Drug Administration and could be on the market in the next few months.
The gastroscope — as well as a next-generation display unit — from Danish medical device company Ambu A/S is designed to be used once and discarded, protecting patients from possible device cross-contamination and addressing workflow challenges that arise when scopes are out of service being reprocessed or repaired.