Mountain View, California-based Claria Medical designed its device to facilitate safe and efficient tissue extraction in hysterectomies. It received authorization after acceptance into the Safer Technologies Program (STeP), expediting its review.
The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program. It covers devices that could improve the safety of treatments or diagnostics.
This technology represents the first integrated tissue containment and removal system cleared by the FDA, the company said in a news release.