Distalmotion Seeks Expanded U.S. Gynecology Use for DEXTER, Advances Myomectomy Trial

New updates have been reported about Distalmotion.

Distalmotion has moved to broaden U.S. indications for its DEXTER robotic surgery platform, filing a 510(k) submission with the Food and Drug Administration in March for sacrocolpopexy, sacrocervicopexy, and endometriosis resection following completion of its SPARO clinical trial in these procedures. If cleared, this would mark DEXTER’s fourth U.S. indication and second in gynecology, directly supporting Distalmotion’s strategy to deepen penetration in ambulatory surgery centers as gynecologic volumes shift from hospitals to outpatient sites.

Management positions these expanded indications as a way for outpatient centers to run more efficient gynecology programs by performing multiple robotic procedure types, such as hysterectomy and sacrocolpopexy, within the same operating day, improving service-line utilization and economics. In parallel, Distalmotion has secured FDA Investigational Device Exemption approval for a U.S. myomectomy trial, targeting a gynecologic segment projected to approach 1 billion dollars by 2030, which could materially increase DEXTER’s addressable market if future regulatory clearances follow. CEO Greg Roche emphasized that DEXTER is engineered for ASC workflows with a small, mobile footprint, open architecture, and flexible console design intended to lower adoption barriers and accelerate learning curves, reinforcing the company’s ambition to make robotic surgery more accessible while driving recurring revenue from single-use instruments and broader multi-specialty use in both the United States and Europe.