Distalmotion has received De Novo Marketing Authorization from the US Food and Drug Administration (FDA) to market the Dexter Surgical Robot for adult inguinal hernia repair.
Dexter integrates into existing operating workflows and is fully compatible with current operating room equipment, safeguarding hospitals’ investments.
Its single-use instruments simplify the process by eliminating reprocessing and boosting workflow efficiency.
Dexter’s mobile design allows for direct access to the patient from the sterile surgeon console, giving surgeons flexibility in technique choice for each procedure step.
According to Switzerland-based Distalmotion, the Dexter Surgical Robot is designed as the “surgeon’s robot,” providing complete control to optimise patient outcomes.
Dexter aims to bring robotic surgery benefits to more hospitals, outpatient departments, and ambulatory surgical centres (ASCs). Its design is said to be simple, modular, and compact, making it accessible for various settings.
As an open system, the robotic system integrates with third-party 3D imaging systems, energy devices, vessel sealers, and other laparoscopic tools.
The system features fully wristed, single-use instruments that offer dexterity and precise movement, ensuring reliable performance while reducing reprocessing needs.
The Swiss medical device company said the Dexter System is specifically intended for laparoscopic inguinal hernia repair in adults aged 22 and older.
Distalmotion CEO Greg Roche said: “We’re excited to bring Dexter to the US 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.”
This approval is expected to help Distalmotion advance robotic surgery. It will also enhance soft tissue robotics in outpatient settings and ASCs, said the firm.
The robotic system is already available in Europe and is now set to enter the US market.
University of California, San Diego (UCSD) hernia surgery director Garth Jacobsen said: “Dexter provides an open concept and the ability to transition from console to bedside seamlessly, resulting in a system that is more ergonomic and operatively efficient than current generation platforms.”
In April 2023, Distalmotion raised $150m to expedite the FDA approval and clinical experience.
