Claria System is the first integrated tissue containment and removal system authorized by the FDA, granted through its Safer Technologies Program for its potential impact on women’s health
MOUNTAIN VIEW, Calif., July 13, 2026 (GLOBE NEWSWIRE) -- Claria Medical today announced that its Claria System, a device for facilitating safe and efficient tissue extraction for minimally invasive hysterectomies, has received FDA marketing authorization and has been granted a De Novo classification. The Claria System was accepted into the Safer Technologies Program (STeP), which is intended to expedite the review of devices expected to significantly improve the safety of currently available treatments. A prospective, multinational, controlled clinical study conducted to support this submission demonstrated favorable safety and performance outcomes.
Today, hysterectomies are the second most common surgery for women, with around 600,000 conducted every year in the United States alone. Approximately 30% of these procedures, which are performed for an enlarged uterus, require special techniques and tools for uterine extraction, such as a containment barrier to prevent tissue dissemination.
For these procedures, the current standard of care can take up to 90 minutes to complete, with well-documented complications and safety concerns, including a risk of bowel injury and containment breach rates as high as 40%. Another common option for surgeons is an open hysterectomy, a more invasive method that brings increased recovery times and additional patient risks.
The Claria System is the first integrated tissue containment and removal system cleared by the FDA. It features an intelligent uterine containment and extraction system designed to improve the safety and speed of hysterectomy procedures for both patients and surgeons. The system’s SafeStop™ technology uses electronic communication between its tri-layer container and the handpiece to prevent unintended safety barrier breaches for safer and less invasive procedures. Its transvaginal approach enables rapid tissue extraction without a mini-laparotomy, and the device’s ergonomic design allows for a more comfortable procedure for surgeons.
In a clinical study, the Claria System demonstrated rapid extraction of large uteri, with a median extraction time of four minutes. Surgeons achieved these strong results with minimal training and had unanimously positive feedback about the device. Claria Medical intends to publicly present detailed data from these studies later this year.
“The safety risks associated with today’s standard of care are simply too high; women everywhere deserve a better, safer method for these vital surgical procedures,” said Claria Medical CEO Alexey Salamini. “The FDA’s authorization as part of the STeP program supports the Claria System’s expected clinical benefit over currently available treatments and provides surgeons with a valuable new tool to address an urgent clinical need. Clearing this hurdle allows us to expedite our efforts to make this improved technology available to health systems, surgeons, and patients around the country."
Claria Medical is backed by private and strategic investors and has been awarded several grants from the National Science Foundation and the National Institutes of Health. With FDA authorization, the company is now turning towards finalizing arrangements for multiple commercial pilot sites around the country with leading healthcare systems.
For more information on Claria Medical, please visit https://clariamedical.com/.
About Claria Medical
Claria Medical is passionate about developing best-in-class treatments to address clinical needs in minimally invasive surgery. Claria’s first product, the Claria System, aims to improve the second most common surgery for women, hysterectomy, and is the first integrated tissue containment and removal system cleared by the FDA. In addition to private financing, Claria Medical has been awarded prestigious National Science Foundation and National Institutes of Health grants to develop products to improve hysterectomy, myomectomy, and other surgical procedures. Claria is located in Mountain View, CA.
Media Contact:
Rebecca Day
rebecca@clariamedical.com
