Distalmotion Seeks FDA Clearance to Expand Dexter Robot Use in Gynecology

Distalmotion has submitted a 510(k) application to the Food and Drug Administration to expand indications for its Dexter robotic surgery system in the U.S.

The company aims to extend Dexter’s use into gynecological procedures such as sacrocolpopexy, sacrocervicopexy, and endometriosis resection. The move supports its strategy to target ambulatory surgical centers (ASCs), where space and infrastructure constraints may favour compact robotic systems.

Dexter is already cleared for procedures including gallbladder removal, hernia repair, and hysterectomy. Expanding into outpatient gynecology marks a key step in the platform’s evolution.

Distalmotion recently completed a safety study in pelvic procedures and secured approval to begin trials in myomectomy. The company is positioning Dexter as a flexible, mobile solution to capture growing demand for robotic-assisted outpatient surgeries.

06-04-2026