Distalmotion Expands FDA Clearance for DEXTER Robotic System in Gynaecology

Swiss medical device company Distalmotion has secured additional US Food and Drug Administration (FDA) 510(k) clearance for its DEXTER robotic surgery system, further expanding its role in minimally invasive gynaecological procedures.

The latest authorisation covers sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection, marking the system’s second FDA clearance specifically within gynaecology and its fourth overall indication in the US.

Expanding the Scope of Robotic Gynaecological Surgery

With this new clearance, DEXTER now supports a broader range of gynaecological procedures beyond its existing approvals for hysterectomy and salpingo-oophorectomy.

The system is also cleared for select general surgery procedures, including inguinal hernia repair and cholecystectomy, reinforcing its positioning as a multi-specialty soft tissue robotic platform.

The expanded indication set is expected to increase adoption in ambulatory surgery centres (ASCs), where efficiency, throughput, and same-day discharge capabilities are increasingly important.

By enabling a wider range of procedures to be performed robotically in outpatient environments, Distalmotion aims to support the continued shift of surgical care away from inpatient hospital settings.

Supporting Outpatient Care Models

Ambulatory surgery centres are under growing pressure to expand service lines while maintaining high procedural efficiency.

DEXTER’s compact design and focus on streamlined robotic assistance are positioned to support this need, allowing care teams to treat a broader range of women’s health conditions without increasing procedural complexity.

The system is designed for laparoscopic procedures across urology, general surgery, and gynaecology, combining robotic precision with workflows tailored to outpatient settings.

Company Perspective on the Clearance

Distalmotion CEO Greg Roche described the clearance as an important step in expanding the system’s clinical footprint in gynaecology.

He said the additional indications help enable a more comprehensive GYN service line, supporting care teams in delivering robotic-assisted procedures alongside same-day discharge pathways.

According to the company, this combination of robotics and outpatient care is central to improving both efficiency and patient access.

Continued Clinical and Commercial Progress

Alongside regulatory expansion, Distalmotion is advancing its US investigational device exemption (IDE) study evaluating DEXTER in myomectomy, further broadening its clinical evidence base in gynaecological surgery.

The company reports that more than 4,000 patients have already been treated using the system across approved indications.

DEXTER is a soft tissue robotic platform designed with single-use instruments and a compact footprint to facilitate integration into operating rooms with varying levels of infrastructure.

Positioning in the Surgical Robotics Landscape

The expansion of FDA clearances reflects broader momentum in surgical robotics, where manufacturers are increasingly focusing on:

• Expanding indications across multiple surgical specialties

• Supporting outpatient and ambulatory care settings

• Improving procedural efficiency and workflow integration

• Increasing adoption of minimally invasive techniques
  

Distalmotion’s strategy aligns with this shift, targeting broader clinical applicability rather than single-procedure robotic systems.

Summary

Distalmotion has secured additional FDA clearance for its DEXTER robotic surgery system, expanding its approved use in gynaecological procedures including prolapse repair and endometriosis treatment.

The move strengthens the system’s position in outpatient surgical care and supports its broader ambition to become a multi-specialty robotic platform across gynaecology, general surgery, and urology.

With continued clinical studies underway and increasing procedural adoption, DEXTER is steadily broadening its footprint in the evolving surgical robotics market.

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