French Tech Hub customer NeoMedLight announced the 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Bilicocoon™ Phototherapy system to treat neonatal jaundice in the United States. The medical device has been marketed outside the United States since September 2016 after receiving CE mark.
Neonatal jaundice is common in newborns, affecting over half of all babies in the first week of life. This condition must be treated to avoid severe complications – including irreversible brain damage.
The Bilicocoon™ is a medical device that delivers homogeneous and powerful light through a piece of conformable fabric. In the case of neonatal jaundice, the technology allows effective and safe treatment of hyperbilirubinemia in the neonates whilst maintaining the parents-child bonding (cocooning, swaddling, kangaroo care) and promoting breastfeeding during the treatment. The combination of treatment and cocooning is unique and most parents and caregivers prefer the Bilicocoon to less friendly alternatives.
“The innovative technology used to develop the Bilicocoon™ system meets the clinical requirements and latest international guidelines to deliver a safe and effective treatment to newborns suffering from neonatal jaundice. The ease of use, comfort and safety of the device responds to the developmental care trend and baby-friendly initiatives observed around the world. Moving forward, the company is still engaged in significant R&D. We are now targeting other pathologies that react to light.” said Pierre Saint Girons, CEO of NeoMedLight.
NeoMedLight, an ISO 13485 certified French startup company is located in Villeurbanne, France. Bilicocoon™ systems have been installed in hospitals and clinics in different countries since December 2016. It is currently sold in 16 countries. Neomedlight Bilicocoon phototherapy solutions are designed in France and have FDA 510(k) clearance, a CE mark and an Australian TGA.