The FDA authorizes the first robotic surgical device to perform a hysterectomy

The FDA has authorized marketing of the Hominis Surgical System, a new robotic-assisted surgical device (RASD) that can help facilitate hysterectomy in some patients.

According to the agency's statement on its official website, the Hominis surgical system is designed for benign hysterectomy (removal of the uterus for non-cancerous cases) with oophorectomy (removal of one or both of the fallopian tubes and ovaries).

“We are offering doctors and patients another option in minimally invasive gynecological surgery for non-cancer cases,” said Benita Ashar, MD, MBA, FACS, Director of the Office of Surgery and Infection Control Devices at the FDA's Center for Devices and Radiological Health. The FDA will support developments in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures.

RASD is a new robotic-assisted surgical device, sometimes referred to as robotic surgical devices or computer-aided surgical devices, that are not actually robots, as the devices cannot perform surgery without direct human control.

RASD enables the surgeon to use computer and software technology to control and move surgical instruments through one or more small ports (incisions or openings) in the patient's body and in a variety of procedures or surgeries. This technology facilitates minimally invasive surgery and complex tasks in confined areas. Inside the body.

To remove the uterus, the Hominis surgical system uses minimally invasive surgical instruments inserted through the vagina, and a video camera inserted endoscopically through a small incision in the abdomen to visualize the instruments inside the patient.

The approach requires fewer incisions in the abdomen compared to a conventional laparoscopic hysterectomy, and during the procedure, surgeons in the operating room control instruments from the console of the Hominis Surgical System.

 The Food and Drug Administration will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room personnel to complete before operating the device.

 All thirty procedures were successfully completed with the Hominis surgical system and there were no conversions to the open surgical approach or other laparoscopic surgical methods.

The U.S. Food and Drug Administration (FDA) has granted a marketing license for the Hominis Surgical System to Memic Innovative Surgery Ltd.