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    November Industry News

    First ever FDA Clearance given to Artificial Intelligence Imaging System That Reduces Dose

    Omega Medical Imaging, manufacturers of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, announced the Food and Drug Administration 510 (k) clearance of FluoroShield™ with their 2020 Cardiac Flat Panel Detector.This is the first in the world to receive such clearance. Read more 

    FDA Guidance Set to Control Bacterial Contamination in Platelets

    Within 18 months, recommendations from The U.S. Food and Drug Administration (FDA) must be adhered to in order toreduce bacterial contamination of platelets stored at room temperature. The FDA will now require additional safety measures beyond a primary bacterial culture. Learn more 

    Promising Results in the Study of Objective Marker for Chronic Pain

    Brain scans focusing on spatial variations in cerebral blood flow correlated with the presence –though not severity –of chronic knee pain, researchers said. Dr. Auer and colleagues set out to determine whether blood flow in what they called “the classic pain connectome” would also define a chronic pain signature. The answer, at least from this small study, was yes. Read more