FDA Approved New Hydrogel to Reduce Uterine Adhesions
The device helps prevent internal scarring in adult women following surgery to remove uterine adhesions.
Updated on Sept. 29, 2026 in Women’s Health
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The FDA has granted premarket approval to the Juveena Hydrogel System, a new product designed to reduce intrauterine adhesion formation after hysteroscopic adhesiolysis. The system will soon be available at select centers across the United States.
Why it matters
Intrauterine adhesions can cause complications following surgery, making this new protective barrier a significant development for reproductive health recovery. It offers a new option for patients seeking to improve healing outcomes after hysteroscopic procedures.
In a pivotal study conducted across 15 U.S. centers, 61.5% of Juveena-treated patients were adhesion-free at week 8 compared to 38.2% of controls. While severe adhesions occurred in 6.1% of those using the device versus 28.6% of controls, 8% of patients experienced device-attributed adverse events.
The players
FDA
The federal agency responsible for protecting public health by regulating medical devices and ensuring the safety and efficacy of new treatments.
Rejoni
A Bedford, Massachusetts-based medical technology company focused on developing devices for reproductive health and surgery.
The details
The Juveena system is administered via a transcervical catheter at the conclusion of a hysteroscopic adhesiolysis. Upon delivery, the hydrogel forms in situ to conform to the shape of the uterine cavity, physically separating the uterine walls to prevent scarring during the recovery phase. The material is designed to liquefy and be naturally discharged from the body within 14 to 21 days.
Timeline
September 29, 2026: The FDA granted premarket approval for the Juveena Hydrogel System.
14 to 21 days: The hydrogel naturally liquefies and is discharged.
8 weeks after surgery: Patients were evaluated in the pivotal study during a second-look hysteroscopy.
Health Landscape
This development represents a new approach to managing post-surgical healing in the context of the hysteroscopic adhesiolysis standard of care. By providing a structural barrier that is absorbed naturally, the device addresses a long-standing challenge in preventing recurrent intrauterine adhesions.
If you are scheduled for surgery to treat uterine adhesions, you may want to discuss with your surgeon whether this new hydrogel technology is appropriate for your specific case. Patients should ask their care team about potential risks, including device-attributed adverse events, before moving forward with this procedure.
The takeaway
The approval of the Juveena Hydrogel System offers a new, physically protective option for women recovering from uterine adhesion surgery. Patients interested in minimizing post-operative scarring should consult with their gynecological surgeon to understand how this technology fits into their care plan.
Further reading
For more information on innovations in reproductive surgery and recovery, see our Women’s Health section.
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