Memic Innovative Surgery has secured de novo marketing authorisation from the US Food and Drug Administration (FDA) for its Hominis robotic surgical system with humanoid-shaped robotic arms.
Hominis is a robot-assisted surgical platform designed for use in a single site and natural orifice laparoscopic-assisted transvaginal benign surgical procedures, including benign hysterectomy.
The authorisation has been given after taking into the clinical data from procedures using the Hominis system on different patients in Belgium and Israel with Drs Jan Baekelandt and Lior Lowenstein.
Claimed to be the first and only FDA-authorised surgical robotic platform, Hominis includes miniature humanoid-shaped robotic arms that are said to offer human level dexterity, multi-planar flexibility and 360 degrees of articulation.
With shoulder, elbow and wrist joints, the biomimetic instruments have been designed to reflect the motions and capabilities of a surgeon’s arms, the company said.
The robotic system enables the introduction of multiple instruments in the body through a single portal. In addition, the 360-degree articulation allows obstacle avoidance as well as optimal access and working angles.
Memic intends to pursue general surgery and transluminal indications for the Hominis platform. To support all its surgical indications, the company is advancing artificial intelligence (AI)-enabled features for the system.
Memic CEO Dvir Cohen said: “We are pleased to receive FDA De Novo authorization 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.”
Last month, Brainlab secured from the FDA for its Loop-X mobile imaging robot and Cirq robotic surgical system for spine.
