Distalmotion’s Dexter Surgical Robot Wins FDA Approval for U.S. Launch

Distalmotion announced it has received FDA de novo approval for its Dexter surgical robot, paving the way for its use in the U.S. for adult inguinal hernia repair. Already used by more than 1,300 patients across Europe, Dexter’s modular design aims to make robotic-assisted surgery more accessible to hospitals, outpatient departments, and ambulatory surgical centers (ASCs).

​

The compact, open-system robot integrates smoothly into existing operating room workflows and works natively with third-party imaging and surgical devices. Featuring fully wristed, single-use instruments, Dexter offers improved movement precision and reduced reprocessing needs. Designed as a “surgeon’s robot,” Dexter allows direct access to patients and full physician control, which Distalmotion CEO Greg Roche believes will empower U.S. healthcare facilities by enhancing surgical practices without added costs or disruptions.