Distalmotion Secures Third FDA Clearance for DEXTER® with Hysterectomy Indication
Lausanne, Switzerland, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Distalmotion, the global MedTech company empowering access to the benefits of robotic surgery in outpatient sites of care, today announced that it has received FDA 510(k) clearance for the use of its DEXTER® Robotic Surgery System in total benign hysterectomy as well as oophorectomy, salpingectomy, and other gynecologic procedures. This milestone marks 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 US,” said Greg Roche, CEO of Distalmotion. “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 sites of care. 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, Gynecology Surgeon, 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 the value of DEXTER in outpatient settings and bringing the system in the US up to the latest global version.
Building on its growing footprint in the US and Europe, DEXTER has been used in over 2,000 procedures across more than thirty 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.
Note: In the United States, the DEXTER® Robotic Surgery System 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.
ABOUT DEXTER
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 comes with 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.
The 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 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.
Indications for use:
Europe: The Dexter L6 System is intended to assist in the accurate control of robotic instruments during urologic laparoscopic surgical procedures, general laparoscopic surgical procedures and gynecologic laparoscopic surgical procedures. The system is indicated for adult use.
US: The Distalmotion Dexter L6 System is intended for use in laparoscopic inguinal hernia repair, cholecystectomy and total benign hysterectomy including salpingo-oophorectomy. The system is indicated for adult use, defined as 22 years old and older.
ABOUT DISTALMOTION
Distalmotion is a global MedTech company with a mission to empower 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), to increase the number of patients who benefit from best-in-class minimally invasive care. 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 with a US office in Cleveland, Ohio.
For more information, visit https://www.distalmotion.com/en-US and connect with us on LinkedIn/Twitter: @Distalmotion.
For media inquiries: press@distalmotion.com
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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.
Attachments
Greg Roche Distalmotion +1 216 440 3775 greg.roche@distalmotion.com
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