Invictus Medical Gets FDA Green Light for Neonatal Device
Children’s medical devicemaker Invictus Medical has received clearance from the FDA for its GELShield to alleviate extracranial pressure caused by prolonged immobility. The device is expected to be used in neonatal intensive care units in the near future, the San Antonio, Texas-based firm said Monday.
The device underwent a comprehensive safety validation study at the Baylor University Medical Center in Dallas. The center oversees roughly 4,200 births every year and operates an 83-bed, level III neonatal intensive care unit providing the highest level of care for newborn babies.
More than 100 hospitals have expressed interest in using the GELShield in their units, Invictus President and CEO Tom Roberts said.
Long-term, Invictus hopes to use its technology to combat deformational plagiocephaly, a cranial deformity in infants resulting from repeated external pressure to one area of the head. DP has been associated with a higher risk of developmental delays. — Kellen Owings