Distalmotion has secured a fresh FDA 510(k) clearance for its DEXTER robotic surgery system, this time for ventral hernia repair — a move the Swiss MedTech says completes its core outpatient portfolio and unlocks the top four highest-volume soft-tissue ambulatory procedures in the United States.
Four Procedures, Three Million Cases
The clearance, supported by data from the Robotic minimAlly invasive Ventral hErNia repair (RAVEN) Study, adds ventral hernia repair to DEXTER's existing US indications of inguinal hernia repair, cholecystectomy and total benign hysterectomy including salpingo-oophorectomy. Together, the four procedures represent more than three million annual cases in the US. Ventral hernia repair alone accounts for more than 600,000 procedures a year, of which over 75% are already ambulatory.
Built For The ASC
DEXTER is purpose-built for ambulatory surgery centers (ASCs) — a small, mobile footprint that fits any operating room without infrastructure changes and can be wheeled between rooms. The sterile console keeps the surgeon at the bedside for quick transitions between laparoscopic and robotic technique. “Until DEXTER, ASCs did not have a surgical robot that fit their physical and economic realities,” said Distalmotion CEO Greg Roche. Dr. Jeffrey Berndtson of Northtowns Ambulatory Surgery Center estimated the ventral hernia nod alone lets his team treat “almost 40% more patients robotically.”
Momentum Against Intuitive
DEXTER has been CE-marked in Europe since 2022 across general, gynecologic and urologic surgery, with over 4,000 patients treated. The Lausanne-based company earlier this year won expanded FDA gynecology clearance, and today's update closes what Roche called a “major strategic milestone.” The push directly targets Intuitive Surgical's dominance in soft-tissue robotics by attacking the outpatient corner of the market. It arrives as competitors race for their own footholds — Medtronic recently pushed its Hugo system into new US indications.
Reporting based on coverage from Distalmotion via GlobeNewswire and The Manila Times.