Memic has received the US Food and Drug Administration (FDA) De Novo marketing authorisation for its Hominis robot-assisted surgical platform.

The De Novo authorisation facilitates the use of the Hominis robotic system in a single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures.

The regulatory authorisation is based on clinical data from procedures using the Hominis system on different patients, conducted by Dr Jan Baekelandt in Belgium and Lior Lowenstein in Israel.

Baekelandt said: “This FDA authorisation represents a significant advance in the world of robot-assisted surgery and fulfils an unmet need in the world of robotic gynaecological surgery.

“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.

“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 US medical device maker said that its Hominis system is the first and only FDA authorised surgical robotic platform that features miniature humanoid-shaped robotic arms.

The robotic arms would provide human-level dexterity, multi-planar flexibility and 360 degrees of articulation.

Also, the biomimetic instruments of the system are designed to imitate the motions and capabilities of a surgeon’s arms, with shoulder, elbow and wrist joints.

Different tools can be introduced to the body through a single portal and the 360-degree articulation avoids obstacles, offering optimal access and working angles, said the company.

Memic intends to seek general surgery and transluminal indications for the Hominis platform and is developing AI-enabled features to support all the surgical indications.

Memic CEO Dvir Cohen said: “We are pleased to receive FDA De Novo authorisation of our Hominis system, which offers a small, cost-effective and less invasive option over current robotic instruments limited to straight shaft and single wrist designs and controlled with large, complex and expensive equipment.

“This authorisation is also just the beginning; it opens the door for our novel system to expand to additional indications that, until now, have been off-limits to robot-assisted surgery.”