The company expects to make available the updated version of the Jada system in the US in January next year
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Global women’s health company Organon has secured clearance from the US Food and Drug Administration (FDA) for technological updates to the Jada system.
The Jada system is developed to deliver control and treatment of abnormal postpartum uterine bleeding or hemorrhage.
It was first cleared by the FDA in August 2020 based on results from the pivotal PEARLE IDE Study, which showed that system helped control abnormal postpartum uterine bleeding and hemorrhage when conservative management is warranted.
The new technological updates for the system include a new kit configuration with updated packaging and a streamlined design to help improve the device’s ease of use.
Organon expects to make available the updated version of the Jada system in the US in January 2022.
The system got included in the Organon women’s health portfolio in June this year, as part of the company’s acquisition of Alydia Health, a commercial-stage medical device company for $240m.
Organon CEO Kevin Ali said: “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.
“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.”
To control and treat abnormal uterine bleeding, the Jada system helps in normal contraction of the uterus by applying low level vacuum.
Formed through a spin-off from Merck, Organon employs nearly 9,000 people with headquarters located in Jersey City, New Jersey.
The company was launched on 3 June this year as a new company with a focus on reproductive health and health issues that affect women.