Organon Receives FDA Clearance for Technological Updates to the Jada® System, a Medical Device Intended to Control Postpartum Hemorrhage
Postpartum hemorrhage is one of the most common complications of birthi Organon (NYSE: OGN), a global women’s health company, today announced clearance by the U.S. Food and Drug Administration (FDA) of the Special 510(k) for technological updates to the Jada® System, intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. The incidence of postpartum hemorrhage due to uterine atony has increased significantly in the United States during the past decade. ii The product updates include a new kit configuration with updated packaging, as well as a streamlined design to help improve the device’s ease of use. “More options in the area of maternal health for healthcare providers and women are urgently needed, which was what motivated Organon’s early acquisition of JADA,” said Kevin Ali, Chief Executive Officer, Organon. “Postpartum hemorrhage continues to be one of the most common complications of childbirth