Prapela’s FDA-Authorized Groundbreaking Therapy for Opioid-Exposed Infants Highlighted at Washington DC Showcase Event

Prapela, Inc. joins America's leading MedTech corporations at AdvaMed’s prestigious Capitol Hill event.

PORTLAND, ME, UNITED STATES, June 10, 2025 /EINPresswire.com/ -- Across the country, hospitals face the continuing challenge of caring for the more than 200,000 newborns exposed to opioids each year. Opioid exposed newborns diagnosed with neonatal opioid withdrawal syndrome (NOWS) experience tremors, wakefulness, irritability, and high-pitched crying. On Wednesday, June 11, Prapela, Inc. will join a select group of the nation’s most innovative MedTech companies on Capitol Hill to showcase their breakthrough technologies. Among them, Prapela will present the only FDA-authorized therapy to help newborns suffering from NOWS.

Prapela^® is proud to be one of the few early-stage companies selected for the 2025 AdvaMed^® Showcase event, highlighting America’s leadership in global medical innovation. This honor comes on the heels of Prapela’s groundbreaking De Novo authorization from the U.S. Food and Drug Administration. The FDA’s decision established a new classification of medical devices: therapeutic vibrational mattress pads explicitly designed for neonates and infants.

The Prapela SVS hospital bassinet pad is indicated as adjunctive non-pharmacological therapy in newborns ≥ 37 weeks gestational age exposed prenatally to opioids with NOWS. Prapela's stimulation has also been awarded FDA breakthrough device designation to improve the treatment of apnea in preterm infants.

“Being selected for the AdvaMed MedTech Showcase event is a tremendous honor, recognizing not just our team, but the clinicians and caregivers who work every day improving care for children and infants,” said John Konsin, principal founder and CEO of Prapela. “We’re proud to stand alongside some of the most respected names in healthcare to spotlight our disruptive innovation.”

About Prapela, Inc.
Prapela, Inc. is a Maine-based company developing therapeutic devices for newborns and infants facing serious medical challenges. Its lead product, the Prapela SVS hospital bassinet pad, received De Novo authorization by the FDA on April 4, 2025. Prapela’s breakthrough therapy has been supported by the National Institutes of Health/National Institute on Drug Abuse, the Wyss Institute for Biologically Inspired Engineering, the Charles H. Hood Foundation, and several other US-based organizations.


Prapela is a registered trademark owned by Prapela, Inc. of Portland, Maine
AdvaMed is a registered trademark owned by the Advanced Medical Technology Association

John P Konsin
Prapela, Inc.
+1 833-772-7352
email us here
Visit us on social media:
LinkedIn
Bluesky
Facebook
YouTube
X

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.