Prapela, Inc. announces it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The designation is for the Prapela SVS hospital bassinet pad used as adjunctive therapy in newborns with prenatal opioid exposure and/or diagnosed with neonatal abstinence syndrome.
Prapela’s SVS pad fits into standard sized hospital bassinet. It provides a gentle, non-habit forming vibration shown in clinical trials to improve breathing, heart rate, and relaxation in pharmacologically managed opioid-exposed newborns.
Prapela was awarded $200,000 through the MLSC’s Milestone Achievement Program.