Revolve Surgical announced that it received FDA 510(k) clearance for its surgical robot platform. The Canada-based company develops what it describes as a first-in-class, zero-footprint surgical platform. It provides robotic assistance to augment surgeons performing soft tissue procedures.
Revolve says its table-mounted system can integrate into existing clinical workflows. Backed by Y Combinator, Revolve states that its ultimate goal is to enable physical AI in operating rooms at scale.
According to the FDA 510(k) database, the electromechanically controlled laparoscopic surgery platform is used for minimally invasive abdominal surgery. It features a reusable system arm that mounts to the operating table and operates under the surgeon’s direct control to manipulate tissues during surgery.
Its FDA clearance covers the general surgery indication. Revolve said it plans to use the device as part of initial pilot studies with an expanded clearance for all laparoscopic surgery, expected ahead of its commercial launch.
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Commentary from Revolve Surgical officials and surgeons
Matthew Kang, Revolve Surgical co-founder, said:
“This clearance is just step one in our rapid regulatory and development strategy. As of today, there’s a new ‘personal’ surgical platform, small enough for one-person setup and operation. We think that form factor and compatibility are critical to increasing access to surgical robotics, particularly in ambulatory surgery centers.”
Alex Gordon, Revolve Surgical co-founder, said:
“Technology, particularly AI, is moving faster than ever before, and in most industries if you have a computer or smartphone you can access it. But in surgery, there’s no universally accessible platform. Revolve’s mission is to build this platform to bring the latest technology and AI advancements to surgeons and their patients everywhere.”
Dr. Ori Rotstein, general surgeon and VP of research and innovation at Unity Health, said:
“We chose to partner with Revolve Surgical because their system offers a new approach that fits into our existing practice. It’s the right solution for our most common procedures, and we are proud to be the first to put this technology into practice.”