Prapela, Inc. Granted FDA De Novo for Breakthrough Therapy Helping the Most Vulnerable Victims of our Opioid Epidemic
Prapela’s SVS hospital bassinet pad is the first and only therapeutic medical device to treat opioid exposed newborns with neonatal opioid withdrawal syndrome.
PORTLAND, ME, UNITED STATES, April 17, 2025 /EINPresswire.com/ — One of the more sorrowful consequences of our opioid crisis is the use of opioids among pregnant women and their impact on newborns. Prenatal opioid exposure (POE) can result in a postnatal withdrawal condition in newborns called neonatal opioid withdrawal syndrome (NOWS). Babies with NOWS experience hyperirritability, sweating, irregular heart and breathing rates, fever, vomiting, and diarrhea.
On April 4, 2024, the FDA granted De Novo classification to the Prapela SVS hospital bassinet pad, making it the first and only medical device with FDA marketing authorization to treat NOWS. The device has the following indication for use:
The Prapela SVS hospital bassinet pad is indicated as adjunctive non-pharmacological therapy in newborns ≥37 weeks gestational age exposed prenatally to opioids with neonatal opioid withdrawal syndrome (NOWS). The Prapela SVS hospital bassinet pad is indicated for prescription use only.
