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Home » Distalmotion submits Dexter surgical robot to FDA for expanded indications in uro-gynecology

Distalmotion submits Dexter surgical robot to FDA for expanded indications in uro-gynecology

April 1, 2026 By Sean Whooley

Distalmotion's surgical robot system, Dexter, in an operating room.
Dexter consists of two small instrument arm carts, an endoscopic arm cart and an open sterile surgeon console. [Image courtesy of Distalmotion]
Distalmotion announced today that it submitted a 510(k) application to the FDA to expand indications for its Dexter surgical robot.

Lausanne, Switzerland–based Distalmotion submitted Dexter for sacrocolpopexy, sacrocervicopexy, and endometriosis resection procedures.

Distalmotion — one of 10 surgical robotics companies you need to know — designed Dexter to deliver robotic benefits to more hospitals, outpatient departments and ambulatory surgical centers (ASCs). The modular, small-format, open system delivers simplicity and straightforwardness, plus more accessibility, Distalmotion says.

Dexter can work natively with third-party 3D imaging systems, energy devices, vessel sealers and other laparoscopic devices. It features a suite of fully wristed, single-use instruments. These instruments offer dexterity, precision of movement, reliable instrument performance and lower reprocessing requirements.

(Learn more about Distalmotion, Dexter and the surgical robotics space in our MassDevice Surgical Robotics Special Report. Download the report for free here.)

In October 2025, Dexter received FDA clearance for total benign hysterectomy as well as oophorectomy, salpingectomy, and other gynecologic procedures. It marks the third approved indication in the U.S. after FDA nods for inguinal hernia repair and cholecystectomy.

Now, following the SPARO clinical trial evaluating Dexter in robotic sacrocolpopexy and sacrocervicopexy, the company hopes to deliver the fourth overall indication and second in gynecology for the robot in the U.S. It says clearance would further support the expansion of service lines in ASCs as well.

The company recently secured significant funding to support its efforts to bring Dexter to ASCs. CEO Greg Roche recently spoke about the ASC push on the DeviceTalks Weekly Podcast.

In addition to the FDA submission, Distalmotion also received FDA approval to conduct a myomectomy trial via investigational device exemption (IDE), furthering its work in gynecology.

In a news release, Roche said:

“Expanding gynecology capabilities in outpatient environments represents an important next step in the evolution of the Dexter robotic program. Dexter is designed to help outpatient centers introduce robotics in a practical way, enabling care teams to build sustainable service lines across multiple specialties. Dexter is purpose-built for ASCs, and our expansion of general surgery and gynecology indications supports the delivery of the combined benefits of wristed robotics and same-day care in a cost-effective way for patients, physicians, and providers alike. This submission reflects our commitment to enabling access to robotic surgery in the ASC environment.”

Filed Under: 510(k), Food & Drug Administration (FDA), Gynecological, Health Technology, Regulatory/Compliance, Robotic-Assisted, Surgical, Surgical Robotics, Urology Tagged With: Distalmotion, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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