MedPath

Distalmotion's Dexter Surgical Robot Receives FDA Approval for Inguinal Hernia Repair

• Distalmotion's Dexter surgical robot has received FDA de novo approval for adult inguinal hernia repair, marking its entry into the U.S. market. • Dexter is designed to integrate into existing surgical workflows, offering a modular, small-format system intended to enhance accessibility and simplicity in robotic surgery. • The system utilizes fully wristed, single-use instruments to provide dexterity and precision while reducing reprocessing needs, potentially benefiting hospitals and ambulatory surgical centers. • Clinical use of Dexter has already begun in Europe, with potential applications across general surgery, gynecology, and urology, according to Distalmotion.

Distalmotion has secured FDA de novo approval for its Dexter surgical robot, paving the way for its introduction into the U.S. market for adult inguinal hernia repair. The Dexter system is already in clinical use in Europe, where more than 1,300 patients have been treated.

Dexter's Design and Functionality

Designed with a focus on simplicity and accessibility, Dexter aims to bring the benefits of robotic surgery to a broader range of healthcare facilities, including hospitals, outpatient departments, and ambulatory surgical centers (ASCs). The system's modular, small-format design allows it to integrate with existing operating room equipment and workflows. Dexter is compatible with third-party 3D imaging systems, energy devices, and vessel sealers, and it features a suite of fully wristed, single-use instruments. These instruments provide surgeons with dexterity and precision of movement, while also reducing the complexities associated with reprocessing.

Clinical Applications and Surgeon Control

Currently utilized in Europe for a range of procedures, Dexter has the potential to treat patients across various complex and high-volume surgical types, including general surgery, gynecology, and urology. Distalmotion emphasizes that Dexter is designed to be the "surgeon’s robot," providing complete physician control throughout procedures. The system also enables quick, direct access to the patient from the sterile surgeon console.

Expert Commentary

Dr. William Hope of the New Hanover Regional Medical Center (North Carolina) views inguinal hernia repair as "an excellent first indication for Dexter." He anticipates that the system's design will "undoubtedly enable more patients to benefit from robotic-assisted surgery."

Company Perspective

Greg Roche, CEO of Distalmotion, stated, "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. Our goal is to enhance existing practices with robotics that support—not disrupt—the way surgical teams operate."
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

NextBioMedical's Nexsphere-F Receives FDA IDE Approval for Knee Osteoarthritis Trial

NextBioMedical's Nexsphere-F has received FDA IDE approval for a clinical trial (RESORB) to treat knee osteoarthritis via genicular artery embolization (GAE).
The RESORB trial is a multi-center, randomized, open-label study evaluating Nexsphere-F's efficacy in alleviating pain and improving mobility in OA patients.

Onward Medical's ARC-EX System Receives FDA Approval for Spinal Cord Injury Treatment

The FDA has granted de novo classification to Onward Medical's ARC-EX system, the first non-invasive spinal cord stimulator approved for SCI patients.
Clinical trials demonstrated that 90% of participants experienced improved strength or function, with 87% reporting a better quality of life.

Nanox's ARC Imaging System Receives FDA Clearance for Expanded Use

Nanox's ARC imaging system secures FDA 510(k) clearance for general use, including pulmonary, intra-abdominal, and paranasal sinus indications, expanding its market potential.
The Nanox.ARC system utilizes digital X-ray technology with cold cathode tomosynthesis, providing enhanced 3D visualization compared to traditional 2D X-rays.

EndoQuest Robotics Receives FDA IDE Approval for Flexible Robotic Colorectal Surgery System

EndoQuest Robotics secured FDA approval for its Investigational Device Exemption (IDE) to initiate a pivotal clinical study of its Endoluminal Surgical (ELS) System.
The PARADIGM study will assess the safety and efficacy of the ELS system in robotic endoscopic submucosal dissection (ESD) for removing colorectal lesions across five U.S. sites.

FDA Grants IDE for Johnson & Johnson's Ottava Surgical Robot, Clinical Trials to Commence

Johnson & Johnson MedTech received FDA IDE approval for its Ottava surgical robot, paving the way for clinical trials in the U.S.
The Ottava system features a unique four-armed design integrated into a standard surgical table, enhancing surgical team flexibility.

FDA Approves Clinical Trials for Johnson & Johnson's OTTAVA Robotic Surgical System

Johnson & Johnson MedTech received FDA approval for an Investigational Device Exemption (IDE) for its OTTAVA robotic surgical system, allowing US clinical trials to commence.
The OTTAVA system features a compact design with four robotic arms and advanced intra-operative repositioning, designed to address unmet needs in robotic surgery.

Momentis Surgical Receives FDA Clearance for Second-Generation Anovo Robotic Surgery Platform

Momentis Surgical secured FDA 510(k) clearance for its second-generation Anovo robotic surgery platform, enhancing surgical capabilities through a single incision.
The upgraded Anovo system offers improved ergonomics, sensory feedback, and a video annotation layer to boost surgical team communication and learning.

FDA Approves Distalmotion's Dexter Surgical Robot for Inguinal Hernia Repair

Distalmotion's Dexter Surgical Robot receives FDA De Novo approval for adult inguinal hernia repair, marking a step in expanding robotic surgery access.
Dexter is designed for high-volume procedures in outpatient settings, addressing the growing demand for cost-effective robotic solutions.

FDA Approves Anovo Robotic System for Ventral Hernia Repair

The FDA has granted 510(k) clearance to Momentis Surgical's Anovo robotic surgery platform for ventral hernia repair, expanding its application beyond gynecological procedures.
Anovo is the only robotic platform approved for minimally invasive abdominal hernia repair using a single entry incision, featuring robotic arms with 360-degree rotation.

FDA Clears IND for Myogenica's MyoPAXon in Duchenne Muscular Dystrophy

Myogenica, a University of Minnesota startup, received FDA clearance for its IND application for MyoPAXon, a stem cell therapy for muscular regeneration.
The planned clinical trial will assess the safety, tolerability, and engraftment of MyoPAXon in adult patients with Duchenne muscular dystrophy (DMD).

Reference News

[1]
Distalmotion wins FDA de novo nod for Dexter surgical robot - MassDevice
massdevice.com · Oct 28, 2024

Distalmotion received FDA de novo approval for its Dexter surgical robot, designed for adult inguinal hernia repair. Dex...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy