Distalmotion has secured a fresh round of US Food and Drug Administration clearance for its DEXTER Robotic Surgery System, adding sacrocolpopexy, sacrocervicopexy, sacrohysteropexy and endometriosis resection to the soft-tissue robot's approved gynecologic indications. The Lausanne, Switzerland MedTech company announced the 510(k) clearance on June 16, 2026.
Fourth FDA clearance overall
The clearance is DEXTER's second in gynecology and its fourth overall, building on earlier general-surgery indications for inguinal hernia repair and cholecystectomy and a prior gynecology nod covering hysterectomy and salpingo-oophorectomy. With the additions, surgeons can now treat a markedly broader range of gynecologic conditions robotically.
Built for the outpatient setting
Distalmotion has positioned DEXTER squarely at hospital outpatient departments and ambulatory surgery centers (ASCs), where throughput and cost pressures are acute. The system pairs a small, mobile footprint with single-use wristed instruments and a sterile open console, letting it slot into existing operating rooms without modification. "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," said Greg Roche, CEO of Distalmotion.
Expanding access to robotic surgery
More than 4,000 patients have now been treated with DEXTER, which is commercially available across the United States and Europe. In parallel with the commercial expansion, Distalmotion is advancing a US Investigational Device Exemption study for DEXTER in myomectomy. The move sharpens competition in a surgical-robotics market where rivals are racing for outpatient share, including CMR Surgical's Versius Plus US launch and Intuitive's da Vinci 5 rollout. Adjacent breakthroughs in medical device innovation underscore how quickly robotic and AI-driven care is scaling.
Reporting based on coverage from GlobeNewswire and Surgical Robotics Technology.