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

Key Insights

• 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.

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."