Lausanne, Switzerland, April 01, 2026 (GLOBE NEWSWIRE) — Distalmotion, the global MedTech company expanding access to robotic surgery in outpatient sites of care, announced that it submitted a 510(k) application to the US Food and Drug Administration (FDA) in March to seek clearance for sacrocolpopexy, sacrocervicopexy, and endometriosis resection for the DEXTER® Robotic Surgery System in the US.
This latest submission follows the completion of the Robotic Sacrocolpopexy and Sacrocervicopexy (SPARO) clinical trial evaluating DEXTER in these procedures. If cleared, this would represent the fourth overall indication and second in gynecology for DEXTER in the US and further support the expansion of service lines in ambulatory surgery centers (ASCs).
As procedures continue to shift from hospitals to outpatient settings, driven by physician, payor, and patient preferences, robotics has become a key enabler of this migration. For ASCs building gynecology programs, expanded robotic indications allow multiple procedure types—such as hysterectomy, sacrocolpopexy, and other benign gynecologic procedures—to be performed within the same operating day, supporting more efficient service line operations.
“Expanding gynecology capabilities in outpatient environments represents an important next step in the evolution of the DEXTER robotic program,” said Greg Roche, CEO of Distalmotion. “DEXTER is designed to help outpatient centers introduce robotics in a practical way, enabling care teams to build sustainable service lines across multiple specialties.”
Distalmotion also received FDA approval for a US myomectomy trial via Investigational Device Exemption (IDE) to further advance its clinical work in gynecology. Myomectomy represents a large procedure segment in US gynecologic surgery, with this market estimated to reach approximately $1 billion by 2030[1].
“DEXTER is purpose-built for ASCs, and our expansion of general surgery and gynecology indications supports the delivery of the combined benefits of wristed robotics and same-day care in a cost-effective way for patients, physicians, and providers alike. This submission reflects our commitment to enabling access to robotic surgery in the ASC environment,” said Mr. Roche.
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 as well as 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: [email protected]
[1] Mordor Intelligence. Myomectomy Market – Growth, Trends, and Forecast (2020–2031). Mordor Intelligence. 2026. Available here
- Distalmotion Seeks to Expand US Indications in Uro-Gynecology with Latest FDA Submission
- ABOUT DEXTER