Prapela has submitted its bassinet pad for FDA clearance as a complementary treatment for newborns suffering from opioid withdrawal. Approval would make Prapela's product the first available medical device to treat newborns diagnosed with neonatal opioid withdrawal syndrome (NOWS).
Thanks to awards sponsored by the FDA, the National Institute on Drug Abuse (NIDA), Ohio, and others, Prapela completed its De Novo submission providing more than 1,700 pages of information.
"De Novo means from the new, so there are no predicate devices or anything like it in the market," said John Konsin, Prapela's Co-founder and CEO. "Once it was designated as a breakthrough device by the FDA, we started our two-year journey documenting independent non-clinical and clinical testing to support our submission. It's been a long road, and we're especially grateful to the organizations supporting our efforts."
The Prapela bassinet pad replaces the mattress found in most hospital bassinets. Unlike standard foam mattresses, Prapela's vibration was found in several studies to help console and improve breathing in newborns. The review process by the FDA will determine if and when Prapela's prescription-only device will be available for sale to hospitals and specialty centers.
Developed by clinicians, scientists, and engineers, Prapela exclusively licensed its technology in 2018. The vibration propels the brain's pacemaker neurons responsible for breathing and heart rate.
