Claria Medical has received FDA De Novo authorization for its Claria System, an integrated tissue containment and removal device designed for minimally invasive hysterectomy procedures.
The device, which was reviewed under the FDA’s Safer Technologies Program (STeP), is the first FDA-authorized system to combine tissue containment and extraction into a single platform. It uses the company’s SafeStop technology to help prevent breaches of the tissue containment barrier during extraction, while enabling tissue removal through a transvaginal approach without requiring a mini-laparotomy.
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According to Claria Medical, the system is intended to improve the safety and efficiency of hysterectomies involving large uteri. In a clinical study, it achieved a median tissue extraction time of four minutes.
CEO Alexey Salamini said:
“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.”
The authorization marks Claria Medical’s first FDA clearance and paves the way for commercialization of the system in the U.S.
