Distalmotion’s DEXTER® Robotic Surgery System Secures FDA 510(k) Clearance for Ventral Hernia Repair
About DEXTER®
Lausanne, Switzerland, Aug. 13, 2026 (GLOBE NEWSWIRE) — Distalmotion, the global MedTech company expanding access to robotic surgery in outpatient sites of care, today announced it has received US Food and Drug Administration 510(k) clearance for ventral hernia repair with its DEXTER Robotic Surgery System. The clearance was supported by data from the Robotic minimAlly invasive Ventral hErNia repair (RAVEN) Study. CE-marked since 2022 in general, gynecologic, and urologic surgery, DEXTER has real-world clinical experience in thousands of hernia repairs in Europe.
“Ventral hernia repair is one of the highest-volume outpatient general surgery procedures,” said Dr. Jeffrey Berndtson, General Surgeon, Northtowns Ambulatory Surgery Center. “This ventral hernia repair approval allows us to use DEXTER to treat almost 40% more patients robotically in our surgery center, which further optimizes the efficiency of our ASC schedule.”
This clearance allows DEXTER to be used in the top four highest volume soft tissue ambulatory procedures in the US, with a combined total annual volume of more than 3 million1: cholecystectomy, hysterectomy, inguinal hernia repair, and ventral hernia repair. Ventral hernia repair represents a major outpatient opportunity with greater than 600,000 performed each year, of which more than 75% are ambulatory2. Together, these indications significantly expand the number of patients benefitting from robotic surgery in a patient-preferred ambulatory surgery center (ASC) setting. For ASC administrators and surgeons, DEXTER supports adding or expanding general surgery and gynecology service lines for efficient, cost-effective outpatient care.
“Securing FDA clearance for ventral hernia repair completes our core outpatient portfolio and marks a major strategic milestone for Distalmotion,” said Greg Roche, CEO of Distalmotion. “Until DEXTER, ASCs did not have a surgical robot that fit their physical and economic realities. With DEXTER, they avoid costly infrastructure changes, additional sterile processing equipment, significant staffing requirements, and large inventories needed to support high-volume robotic programs, allowing them to focus on providing patient-centric care to more members of their communities.”
Purpose-built for ASCs with a small and mobile footprint, DEXTER provides unique surgeon bedside access and open architecture compatibility with all visualization systems as well as an efficient learning curve for setup and use.
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 and ventral 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.
For media inquiries: [email protected]
[1]: Overview of Major Ambulatory Surgeries Performed in Hospital-Owned Facilities, 2019 #287. Accessed August 12, 2026. https://hcup-us.ahrq.gov/reports/statbriefs/sb287-Ambulatory-Surgery-Overview-2019.jsp
[2]: McCartney J. New Approaches, Trends Are Emerging in Hernia Repair. 2023. Accessed August 11, 2026. https://www.facs.org/for-medical-professionals/news-publications/news-and-articles/bulletin/2023/march-2023-volume-108-issue-3/new-approaches-trends-are-emerging-in-hernia-repair/
Attachments
- Distalmotion's DEXTER® Robotic Surgery System Secures FDA 510(k) Clearance for Ventral Hernia Repair
- About DEXTER®
CONTACT: Greg Roche Distalmotion +1 216 440 3775 [email protected]
