Organon today said it has received FDA 510(k) clearance for technological updates to its Jada system.
Jersey City, N.J.-based Organon designed the Jada system to control and treat abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. The new product updates in the clearance include a new kit configuration with updated packaging and a streamlined designed 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,” CEO Kevin Ali said in a news release. “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.”
The Jada system applies a low-level vacuum to encourage normal contraction of the uterus to help provide control and treatment of abnormal uterine bleeding or hemorrhage following childbirth, according to the company. It was first cleared by the FDA in August 2020.