Distalmotion has received U.S. Food and Drug Administration (FDA) 510(k) clearance to use its DEXTER Robotic Surgery System in total benign hysterectomy as well as oophorectomy, salpingectomy, and other gynecologic procedures. The authorization is the company’s third approved indication in the United States, following prior FDA clearances for inguinal hernia repair and cholecystectomy.

“Hysterectomy is a foundational procedure in women’s health, with over 600,000¹ cases performed annually in the U.S.,” Distalmotion CEO Greg Roche said. “With FDA clearance for three of the top five soft tissue procedures performed in ambulatory surgery centers²—inguinal hernia, cholecystectomy, and now hysterectomy—DEXTER offers ambulatory surgery centers a right-sized solution to provide the benefits of robotic surgery in a convenient surgical setting.”

As one of the highest volume gynecologic surgeries, hysterectomy is increasingly performed in outpatient centers. As more soft tissue procedures migrate to outpatient settings, there is growing demand for robotic solutions that deliver enhanced dexterity, precision, and surgeon ergonomics—without requiring dedicated robotic OR infrastructure or compromising on efficiency and cost.

“Access to robotics has long been a challenge for gynecologists due to limited block time availability,” said Dr. Erica Stockwell, a gynecology surgeon with AdventHealth Celebration. “DEXTER solves this with a mobile robot that can be shared by various specialties, giving us the access we’ve been waiting for. Having immediate bedside access to my patient during a robotic procedure also gives me control of the procedure and helps reduce staffing needs.”

Included in this regulatory clearance is an enhanced version of the DEXTER system. These enhancements are designed to simplify operating room setup, streamline procedural workflows, and optimize instrument performance—further strengthening DEXTER’s value in outpatient settings and bringing the U.S. system up to the latest global version. 

Building on its growing footprint in the United States and Europe, DEXTER has been used in more than 2,000 procedures across 30-plus procedure types in general, gynecological, colorectal, and urological surgery—including over 250 hysterectomies in Europe. Distalmotion continues to advance its work in gynecology with its recently completed sacrocolpopexy (SPARO) and initiation of its myomectomy (REAL-M) clinical trials.

In the United States, DEXTER is authorized for use in adult inguinal hernia repair, cholecystectomy, and the following gynecologic procedures: total benign hysterectomy, oophorectomy, salpingectomy, and combinations of these procedures, as well as adnexectomy and tubal ligation. 

The DEXTER Robotic Surgery System is a soft tissue surgical robot that uniquely simplifies operations to make the benefits of wristed robotics accessible in any operating room (OR). DEXTER includes a suite of fully wristed single use robotic instruments that enhance dexterity and precision. A small, mobile footprint allows DEXTER to integrate into any size OR without modifications, and to be easily maneuvered between rooms to optimize efficiency. Its sterile console supports flexible surgical workflows by positioning the surgeon close to the patient for quick bedside access, seamless transitions between laparoscopic and robotic techniques as desired, and enhanced communication with OR teams.

DEXTER’s open architecture enables compatibility with existing and future OR technologies, including visualization systems and advanced devices, for cost effective supply chain operations. Its instinctive design ensures an efficient, effective learning curve for setup and use. 

Distalmotion is a global medtech company empowering access to the benefits of robotic surgery by simplifying operations with its DEXTER robot. The company aims to broaden access to robotic surgery for more surgeons and sites of care globally, including hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs). Well-suited to any size OR, DEXTER is easily moved, quickly set up, and seamlessly integrated into existing procedures. DEXTER is commercially available in the United States and Europe. The company is headquartered in Lausanne, Switzerland, and maintains a U.S. office in Cleveland, Ohio.

References
¹ Harvey SV, Pfeiffer RM, Landy R, Wentzensen N, Clarke MA. Trends and predictors of hysterectomy prevalence among women in the United States. Am J Obstet Gynecol. 2022;227(4):611.e1-611.e12. doi:10.1016/j.ajog.2022.06.028.
² https://hcup-us.ahrq.gov/reports/statbriefs/sb287-Ambulatory-Surgery-Overview-2019.jsp, accessed 7/26/25.