Korean medical-robotics firm Endorobotics has secured U.S. FDA approval for its incisionless surgical robot ROBOPERA and signed a global exclusive distribution deal with Olympus, positioning the platform for worldwide rollout through the world's largest endoscopy vendor.
An Incisionless Robot That Rides An Endoscope
ROBOPERA breaks with the paradigm popularised by Intuitive Surgical's da Vinci: instead of cutting incisions to insert robotic instruments, the system uses a robotic arm that attaches to and detaches from the tip of a standard diagnostic endoscope already in hospitals. Endorobotics approaches lesions via the mouth or anus, then activates the multi-axis arm for endoscopic submucosal dissection (ESD) — the technique used to treat early-stage stomach and colorectal cancer. That structural choice slashes hospital adoption cost because facilities keep their existing endoscopic workflow.
FDA 510(k), NAY Product Code And A Series C War Chest
The FDA cleared ROBOPERA under 510(k) in September 2025, making Endorobotics the first Korean company to obtain the "NAY" product code — the same regulatory classification as da Vinci. The clearance was followed by a 32.5 billion won (roughly $23 million) Series C at year-end 2025 that included a strategic investment from Olympus, laying the groundwork for the exclusive distribution deal signed in May 2026 and highlighted this month by Korea's Innovation Foundation (COMPA) as a public-research commercialization success.
A Global Distribution Ramp Through Olympus
Olympus is the world's dominant endoscopy manufacturer, and the deal gives Endorobotics access to its clinical sales force across the U.S., Europe and Asia. That could accelerate ESD adoption meaningfully — until now, ESD has been a highly skill-dependent procedure limited to a small pool of expert operators. Endorobotics joins a wave of surgical-robotics platform launches this month, including J&J's OTTAVA de novo authorization and Medtronic's Touch Surgery Aide platform. Related coverage: Medicaroid Hinotori CE mark.
Reporting based on coverage from Seoul Economic Daily, MassDevice, MedTech Dive, AuntMinnie and the FDA 510(k) database (K244029).