Spark Biomedical Receives FDA Breakthrough Device Designation for Infant Transcutaneous Auricular Neurostimulation (tAN™) Device, The Roo™ System Dallas, Texas, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Spark Biomedical, Inc. announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Roo System: a...