Israel-based Momentis Surgical has received the US Food and Drug Administration (FDA) 510(k) approval for its second-generation Anovo robotic surgical platform.
The system previously received an FDA De Novo marketing authorisation for single-site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures.
The surgical robotic platform provides superior reach and articulation from a single incision.
It features miniature humanoid-shaped robotic arms that provide human-level dexterity, multi-planar flexibility and 360 degrees of articulation.
Additionally, the platform features a new annotation-enabled video overlay that enhances in-room communication and supports teaching and collaboration among medical teams.
Momentis Surgical CEO Dvir Cohen said: “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.
“This new FDA clearance is another milestone in the execution of our long-term plan to take robot-assisted surgeries to the next level.”
The robotic-assisted surgical technology company said the second-generation Anovo platform is developed based on years of clinical insights.
It features several upgrades, including the first FDA-approved robotic system that can operate in both retroflexion and anteflexion, to enhance surgeon experience.
The platform’s integrated haptic feedback provides surgeons with enhanced ergonomics, along with enhanced intuitive control of the robotic arms during surgical procedures.
Cohen added: “We are building strong momentum following the impressive clinical outcomes we’ve achieved in gynaecology. 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.”
