The Jada System helps in controlling and treating abnormal uterine bleeding or haemorrhage after childbirth. Credit: freestocks / Unsplash.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.