• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Special Reports
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Resources
    • About MassDevice
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
    • In-Depth Coverage
    • Latest News
  • Attend DeviceTalks
    • Events
      • DeviceTalks Minnesota – May 4
      • DeviceTalks Boston – May 27–28
      • DeviceTalks West
      • DeviceTalks Tuesdays
    • DeviceTalks Podcast Network
      • DeviceTalks Weekly
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Advertise
  • Subscribe
Home » Distalmotion wins FDA de novo nod for Dexter surgical robot

Distalmotion wins FDA de novo nod for Dexter surgical robot

October 28, 2024 By Sean Whooley

Distalmotion Dexter Surgical Robot (1)
The Dexter surgical robot. [Image courtesy of Distalmotion]
Distalmotion announced today that it received FDA de novo approval for its Dexter surgical robot for adult inguinal hernia repair.

Lausanne, Switzerland–based Distalmotion can now bring Dexter to the U.S. with more than 1,300 patients already treated in Europe.

The company designed Dexter to deliver robotics’ benefits to more hospitals, outpatient departments and ambulatory surgical centers (ASCs). As a modular, small-format, open system, it offers simplicity and straightforwardness, plus more accessibility, according to the company.

Distalmotion said 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 deliver dexterity, precision of movement, reliable instrument performance and lower reprocessing requirements.

The company says Dexter seamlessly integrates into existing workflows and works with current operating room equipment. The single-use instruments also remove the complexities of reprocessing to further enhance workflow efficiency. Dexter’s design enables quick, direct access to the patient from the sterile surgeon console as well. Distalmotion said it designed Dexter to be the “surgeon’s robot,” providing complete physician control for procedures.

Currently in day-to-day clinical use in Europe, Dexter could treat patients across complex and high-volume procedure types. That includes general surgery, gynecology and urology. Distalmotion raised $150 million last year to progress its regulatory efforts in the U.S. (The company featured on MassDevice’s list of 10 surgical robotics companies you need to know in 2024.)

In a news release, Dr. William Hope of the New Hanover Regional Medical Center (North Carolina) called inguinal hernia repair “an excellent first indication for Dexter.” Hope expects the design to “undoubtedly enable more patients to benefit from robotic-assisted surgery.”

“We’re excited to bring Dexter to the U.S. market and empower healthcare facilities with a robotic solution that addresses the barriers of cost, space, and workflow disruption,” commented Greg Roche, Distalmotion’s CEO. “Our goal is to enhance existing practices with robotics that support—not disrupt—the way surgical teams operate.”

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

More recent news

  • Sequel Med Tech’s automated twiist pump scores FDA clearance in type 2 diabetes
  • FDA posts alert for Edwards Lifesciences mitral valve delivery system after patient death
  • Former Medtronic RDN leader joins Teleflex
  • CMR Surgical CEO outlines the path forward for Stryker’s robotics partnership
  • Stryker earns FDA clearance for new bone and soft tissue removal platform

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].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >
MDO ad
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2026 · Arrowfly LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Arrowfly.

Privacy Policy