Momentis Surgical Earns FDA Nod for 2nd-Gen Surgical Robot

Momentis Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its second-generation Anovo robotic surgical platform.

The system’s first approval was a de novo authorization for Anovo in single-site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures including benign hysterectomy. According to the company, it’s the first and only FDA-authorized surgical robotic platform that has miniature humanoid-shaped robotic arms that offer human level dexterity, multi-planar flexibility, and 360 degrees of articulation.

The second-gen Anovo platform has a suite of upgrade to boost surgeon experience and use. This includes the first FDA-cleared robotic system—single-port or multi-port—that can operate in both retroflexion and anteflexion.

The new platform also touts integrated haptic feedback and annotation-enabled video overlay.

“This second-generation platform, combined with our expanded surgical indications, underscores our commitment to the long-term plan of transforming the field of robotic surgery with our versatile surgical platform,” said Momentis Surgical CEO Dvir Cohen. “This new FDA clearance is another milestone in the execution of our long term plan to take robot-assisted surgeries to the next level.”

Momentis Surgical is backed by leading life sciences investors, including Peregrine Ventures, Ceros, OurCrowd and Accelmed.

“We are building strong momentum following the impressive clinical outcomes we’ve achieved in gynecology,” said Cohen. “Our focus now is on expanding Anovo’s applications to additional indications, including general surgery. Alongside these advancements, we aim to broaden our global presence and look forward to introducing Anovo to markets in Europe and Asia in the future.”