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October 12, 2021

US FDA grants 510(k) clearance for latest version of Organon’s Jada system

The US FDA approval is based on results obtained from the pivotal PEARLE IDE Study.

The US Food and Drug Administration (FDA) has granted Special 510(k) clearance for technological updates to Organon’s Jada System.

Jada System is an intrauterine medical device that is designed to provide control and treatment of abnormal postpartum uterine bleeding or haemorrhage.

The device got included in the company’s women’s health portfolio, as part of its acquisition of commercial-stage medical device company, Alydia Health, in June.

It was initially approved by the US FDA in August 2020 depending on the results obtained from the pivotal PEARLE IDE Study.

The data from the study demonstrated that the Jada System helped in controlling abnormal postpartum uterine bleeding as well as haemorrhage when conservative management is warranted.

The latest technological updates for the device include a streamlined design, which helps improve the device’s ease of use, and a new kit configuration with updated packaging.

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 haemorrhage 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 company stated that the Jada System helps in normal contraction of the uterus by applying low-level vacuum to control and treat abnormal uterine bleeding or haemorrhage after childbirth.

It expects to make the updated version of the device available in the US in January 2022.

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