Hominis from Memic cleared by FDA

 

"The FDA announced today that it authorized marketing for Memic Innovative Surgery’s Hominis system for transvaginal hysterectomy.  Hominis is the first FDA-approved robotically-assisted surgical device for performing transvaginal hysterectomy, with indication for performing benign hysterectomy with salpingo-oophorectomy, according to an FDA news release."

"Developed by Tel Aviv, Israel-based Memic Innovative Surgery, the Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries). Hominis is also the first robot-assisted surgical device with arms designed to replicate the motions and capabilities of a surgeon's arms, with shoulder, elbow, and wrist joints, allowing the surgical robot device to access and reach through areas not possible with other robots."

"Memic, a medical device company dedicated to transforming robot-assisted surgery with its proprietary technology, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization of its Hominis® robot-assisted surgical platform for use in single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures including benign hysterectomy. The De Novo authorization is supported by clinical data from procedures using the Hominis system on a variety of patients in Belgium and Israel with Drs. Jan Baekelandt and Lior Lowenstein, respectively.  "This FDA authorization represents a significant advance in the world of robot-assisted surgery and fulfills an unmet need in the world of robotic gynecological surgery," said Professor Jan Baekelandt, MD, PhD, a gynecologist at Imelda Hospital in Bonheiden, Belgium, who performed the first hysterectomy using the Hominis system in November 2018. "Research shows vaginal hysterectomy provides optimal clinical benefits to patients including reduced pain, recovery time and rates of infection but in most countries the incidence of vaginal hysterectomy is decreasing. In addition, transvaginal approaches result in no visible scars, which is very important to the gynecological patient. Hominis is the only robot specifically developed for transvaginal surgery and is therefore small and flexible enough to perform surgery through a small incision."  The Hominis (Latin for humanoid) system is the first and only FDA-authorized surgical robotic platform that features miniature humanoid-shaped robotic arms that provide human level dexterity, multi-planar flexibility and 360 degrees of articulation. The biomimetic instruments are designed to replicate the motions and capabilities of a surgeon's arms, with shoulder, elbow and wrist joints. Multiple instruments can be introduced to the body through a single portal and the 360-degree articulation offers obstacle avoidance as well as optimal access and working angles. In addition to these features, the system will be sold at a significantly lower price compared to other marketed robotic surgery systems, potentially allowing more medical facilities including hospitals and ambulatory surgical centers to access and adopt surgical robotics."

Source: Memic, MassDevice, MedGadget, MDDI