Lausanne, Switzerland, June 16, 2026 (GLOBE NEWSWIRE) — Distalmotion, the global MedTech company expanding access to robotic surgery in outpatient sites of care, today announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection for the DEXTER® Robotic Surgery System.
This is the second US clearance for DEXTER in gynecology and the fourth overall, including general surgery indications for inguinal hernia repair and cholecystectomy. This latest clearance adds to the previous gynecology clearance, which included hysterectomy and salpingo-oophorectomy.
In ambulatory surgery centers (ASCs), where efficiency is critical, these additional procedures enable administrators to expand their gynecologic surgery service line while meeting both the demand for robotics in women’s health and efficiency metrics to maximize system utilization and increase throughput. With DEXTER, surgeons can now treat their patients robotically across diverse gynecologic conditions in a more convenient, lower cost site of care.
“Securing FDA clearance for these additional GYN indications is another important milestone for the DEXTER program,” said Greg Roche, CEO of Distalmotion. “By enabling a comprehensive GYN service line, we are empowering care teams to maximize their workflows and deliver the combined benefits of robotics and same-day care to a broader patient population.”
In parallel with this commercial expansion, Distalmotion continues to advance its clinical pipeline with its US Investigational Device Exemption (IDE) study for DEXTER in myomectomy.
With more than 4,000 patients treated with DEXTER, Distalmotion continues to advance its mission to expand access to robotic surgery across high-volume outpatient procedures.
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, total benign hysterectomy including salpingo-oophorectomy, and sacrocolpopexy. 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 surgery 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.
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- Distalmotion Supports ASCs in Expanding GYN Service Lines with US FDA 510(k) Clearance for Additional Gynecology Indications
- About DEXTER® Robotic Surgery System