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In August 2019, the FDA expressed concerns about duodenoscopes, citing continually high levels of contamination and difficulties in cleaning them for reuse, and recommended that users switch to ones with disposable components. Read More
“Accuracy [of the system] is not dependent on the position of the patient's spine or patient movement that may occur over the course of the procedure,” 7D said. Read More
The accompanying wearable device sends data to the cloud for storage and distribution to hospital systems, the Vitls app and other connected devices. Read More