www.fdanews.com/articles/201611-fda-oks-robotically-assisted-surgical-device-for-transvaginal-hysterectomies
FDA OKs Robotically-Assisted Surgical Device for Transvaginal Hysterectomies
March 2, 2021
The FDA has granted De Novo approval for Memic Innovative Surgery’s Hominis Surgical System, the first robotically-assisted surgical device for facilitating transvaginal hysterectomy in certain patients.
The minimally-invasive device, which is intended for benign hysterectomy with salpingo-oophorectomy — removal of the ovaries and fallopian tubes — uses surgical instruments inserted through the vagina and a video camera inserted laparoscopically.
The device’s transvaginal approach reduces the number of incisions needed on the abdomen compared to conventional laparoscopic hysterectomy.