Following on from a previously granted FDA De Novo marketing authorisation, Momentis’ second-generation Anovo robotic surgical platform had previously only seen use at a single site. Credit: Momentis

Florida-based robotic surgery firm, Momentis Surgical, has announced that its second-generation surgical gynaecology robot equipped with miniature humanoid-shaped robotic arms, has been granted 510(k) clearance from the US Food and Drug Administration (FDA).

Following on from a previously granted FDA De Novo marketing authorisation, Momentis’ second-generation Anovo robotic surgical platform had previously only seen use at a single site, used only for laparoscopic-assisted transvaginal benign surgical procedures including benign hysterectomies. Now, the device is open to the wider market.

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Momentis claims that its newest model comes with a suite of software upgrades including the first FDA-cleared robotic system (single-port or multi-port) capable of operating in both retroflexion and anteflexion in uterine procedures. The robot also comes with a new annotation-enabled video overlay system designed to be used to enhance teaching and communication.

Dvir Cohen, CEO of Momentis Surgical, 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.

“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.”

At the end of 2023, the global market for robotic surgical systems was estimated to be valued at $3.3bn, with that figure expected to rise to $7.2bn in 2033 according to GlobalData, which found that the expansion of the surgical robotics market can in part be attributed to growing elderly population, as well as a drive towards value-based healthcare.

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Michael Conditt, SVP of strategic marketing and clinical development at Momentis, said: “The small size and ease of use of the Anovo platform make it ideal for more surgeons to offer patients robotic surgery solutions at sites of care beyond the hospital setting, like outpatient Ambulatory Surgery Centers.

“The new features of our second-generation system will enable us to pursue further indication expansions into bariatric, colorectal and ENT surgeries.”

Elsewhere in the robotic surgical market, the FDA has also granted de novo marketing clearance to CMR Surgical’s Versius surgical robotic system, designed to perform soft tissue minimal access surgery for cholecystectomies.