Benzinga | Oct 11, 2021 07:34AM EDT

Organon Receives FDA Clearance For Technological Updates To The Jada System, A Medical Device Intended To Control Postpartum Hemorrhage

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(r) 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 and this recent FDA clearance supports our ability to continue providing healthcare providers this important option for treating women with abnormal postpartum bleeding."

JADA became part of the Organon women's health portfolio in June 2021, as part of the company's first acquisition, continuing to build upon the company's vision of a better and healthier every day for every woman around the world. Organon estimates this updated version of the Jada System should be available to customers in the United States in January 2022.