Spark Biomedical announced today that the FDA granted breakthrough device designation to its transcutaneous electrical nerve stimulator designed to reduce signs and symptoms of neonatal opioid withdrawal syndrome (NOWS).
NOWS results from exposure to prescription or non-prescription opioids such as methadone or heroin during pregnancy. Currently, no nationwide standard of care exists for managing NOWS, although oral morphine weaning for a national average of 21 days is common practice.
Get the full story on our sister site, Medical Design & Outsourcing.