Jada Medical Device

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Postpartum Hemorrhage Control | The Jada® System

https://www.thejadasystem.com/

The Jada System can provide visible and observable control of bleeding within minutes.* Low-level vacuum (80 mm Hg +/- 10 mm Hg, not to exceed 90 mm Hg) induces …

FDA Clears Updates to Jada System, a Device to …

https://www.empr.com/home/news/fda-clears-updates-to-jada-system-a-device-to-control-postpartum-hemorrhage/

Jada was first approved in August 2020 based on data from the PEARLE IDE study (ClinicalTrials.gov Identifier: NCT02883673 ), which showed that the device was …

Profile of the Jada® System: the vacuum-induced …

https://pubmed.ncbi.nlm.nih.gov/34355991/

Areas covered: This profile describes the Jada System, a novel intrauterine vacuum-induced hemorrhage control device that provides a rapid and effective treatment option for …

Jada System for Postpartum …

https://www.medgadget.com/2020/09/the-jada-system-for-postpartum-hemorrhage-interview-with-rob-binney-ceo-of-alydia-health.html

Alydia Health, a company based in Menlo Park, California, has developed the Jada System, a device designed to …

Vacuum-induced Hemorrhage Control System …

https://www.organon.com/product/usa/pi_circulars/j/jada/jada_system_ifu_blue_seal.pdf

The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. …

Organon Receives FDA Clearance for Technological …

https://www.organon.com/news/organon-receives-fda-clearance-for-technological-updates-to-the-jada-system-a-medical-device-intended-to-control-postpartum-hemorrhage/

October 11, 2021 7:30 am EDT. Postpartum hemorrhage is one of the most common complications of birthi. JERSEY CITY, N.J.-- (BUSINESS WIRE)-- Organon …

The story of the Jada for new mothers …

https://fortune.com/2022/12/28/alydia-health-jada-system-maternal-deaths-womens-health-gender-bias/

As medical devices go, Jada, a wand-like tool that is inserted in the uterus, was unbelievably simple. But as a device designed to address a pregnancy-related problem—an area of …

Intrauterine Vacuum Device Quickly and Safely Controls …

https://consultqd.clevelandclinic.org/intrauterine-vacuum-device-quickly-and-safely-controls-postpartum-hemorrhage/

About the device Made of medical-grade silicon, the Jada System consists of an elliptical intrauterine loop on the distal end and a vacuum connector on the proximal …

Coding Tip: What is the Jada Device? - hiacode.com

https://hiacode.com/blog/jada-device

The Jada device is also referred to as the “Jada System.” It is used to control abnormal postpartum uterine bleeding. The balloon like device is inserted into the vagina to the uterus and …

510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201199

Device Classification Name. intrauterine tamponade balloon. 22. 510 (k) Number. K201199. Device Name. Jada System. Applicant. Alydia Health.

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