We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
The test is only authorized for the duration of the COVID-19 pandemic and the labeling must state that the test “has not been FDA approved or cleared,” the agency said. Read More