This de novo minimally invasive system was designed for safer hysterectomies

Claria Medical won FDA de novo classification in July 2026 for its minimally invasive system for hysterectomy. Hysterectomies are among the most common surgeries for women, but 'many current approaches fall short,' the Mountain View, California-based company says at its website. 'High container breach rates risk hidden cancer spread or bowel injury,' the company said. 'Significant abdominal incisions leave scars and cause unnecessary hospital readmissions [and] procedure times are highly variable.' Claria Medical describes its new option as 'an intelligent system designed for safe extraction of an enlarged uterus using a vaginal approach with no mini-laparotomy, minimizing patient risk, recovery and scarring.' Watch on-demand: The 2026 MDO Min-Vasive Medtech webinar series In 2023, Claria Medical secured a strategic investment from Organon in a deal that gave the publicly traded device developer the option to acquire Claria Medical. Caria also says it has won grants from the National Science Foundation and National Institute of Health to 'develop products to improve hysterectomy, myomectomy and other surgical procedures.' How the minimally invasive Claria system works The Claria system is indicated for 'contained cutting, coring and extraction of tissue during laparoscopic hysterectomy,' according to the FDA classification order. The device was accepted into the FDA's Safer Technologies Program (STeP), which is designed to expedite review for devices that could improve the safety of treatment or diagnostics. The FDA's de novo classification for the Class II device created a new generic device type called 'gynecologic power morcellator and containment system.' The FDA defined that kind of device as 'a prescription device consisting of an integrated power morcellator and a containment method that are intended to contain, reduce and remove gynecologic tissue that is not suspected to contain malignancy during minimally invasive surgery.' The Claria system consists of three components: a handpiece, a container and a console that allows for communication between the two. The handpiece has integrated lighting and a rotating cutter with a 34 mm cutting blade. The container has a triple-layer design with a metallic cloth layer to prevent damage. The system's SafeStop feature stops the blade rotation upon contact with the metallic layer of the container using electronic communication between the container and the handpiece, a feature designed to prevent organ injury and tissue spread. To perform a hysterectomy with the system, the uterus is first detached from the body laparoscopically. Then the container is inserted through the vagina into the abdominal cavity and the uterus is placed into the container. The rim of the container is then externalized, and the handpiece is inserted into the container. A tenaculum is inserted through the handpiece to grasp the tissue. The blade begins tissue reduction and when the tissue is sufficiently reduced, the handpiece and the container (with any remaining portion of the uterus) are removed.The FDA added a requirement for the device's labeling to include a contraindication for use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy. There is also a contraindication for the removal of uterine tissue containing suspected fibroids in patients who are post-menopausal, over the age of 50 or candidates for en bloc tissue removal through the vagina or via a mini-laparotomy incision. The FDA left room for this contraindication to be lifted if clinical data supports it. When used in women with fibroids, the system is indicated for women who are premenopausal and under age 50. The FDA also required the labeling to carry a boxed warning identifying the risk of unsuspected cancer, the potential for dissemination and that use of this device has not been clinically demonstrated to reduce that risk. You can learn more about the system and watch a video depicting the procedure at Claria Medical's website.