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Swiss medical device company Distalmotion has received US Food and Drug Administration (FDA) 510(k) clearance for additional gynecology indications on its DEXTER® Robotic Surgery System, broadening the range of procedures that can be performed robotically in outpatient settings.
The clearance covers sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection, marking the company’s second FDA clearance in gynecology and fourth overall for the DEXTER platform.
The latest authorization builds on DEXTER’s previous gynecology clearance for hysterectomy and salpingo-oophorectomy and follows earlier clearances in general surgery for inguinal hernia repair and cholecystectomy.
According to Distalmotion, the expanded indications are particularly relevant for ambulatory surgery centers (ASCs), where operational efficiency and procedure volumes play an important role in service line development. The additional procedures allow providers to broaden their gynecologic offerings while meeting growing demand for robotic-assisted surgery in women’s health.
Greg Roche, CEO of Distalmotion, described the clearance as another milestone for the DEXTER program.
“Securing FDA clearance for these additional GYN indications is another important milestone for the DEXTER program,” said Roche.
“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.”
The company noted that surgeons can now use DEXTER across a wider range of gynecologic conditions in outpatient settings, supporting access to robotic-assisted procedures in lower-cost sites of care.
Alongside its commercial expansion efforts, Distalmotion continues to advance its clinical development activities. The company is currently conducting a US Investigational Device Exemption (IDE) study evaluating DEXTER for myomectomy procedures.
To date, more than 4,000 patients have been treated using the DEXTER system, reflecting the company’s ongoing efforts to increase access to robotic surgery for high-volume outpatient procedures.
Designed for soft tissue surgery, the DEXTER Robotic Surgery System features fully wristed single-use robotic instruments intended to enhance surgical precision and dexterity. The system’s compact and mobile design allows it to be integrated into operating rooms without requiring structural modifications and enables movement between surgical suites as needed.
DEXTER also incorporates a sterile console that allows surgeons to remain close to the patient and operating room team, supporting communication and flexible transitions between laparoscopic and robotic techniques during procedures. Its open architecture is designed to work with existing operating room technologies and visualization systems, helping healthcare facilities integrate robotic capabilities into established workflows.
Headquartered in Lausanne, Switzerland, with a US office in Cleveland, Ohio, Distalmotion focuses on expanding access to robotic surgery across hospitals, hospital outpatient departments, and ambulatory surgery centers. The DEXTER system is commercially available in both the United States and Europe.
As robotic surgery continues to gain traction across outpatient settings, these developments and broader conversations around innovation, market access, and healthcare technology will be explored at MedTech World Asia 2026, taking place from 26–28 August at the Hong Kong Convention and Exhibition Centre, Hong Kong. The event will bring together MedTech leaders, investors, healthcare providers, and innovators from across the region and beyond to discuss emerging trends, industry challenges, and opportunities across the healthcare sector. Reserve your seat now if you haven’t already.
