Distalmotion, the global MedTech company empowering access to the benefits of robotic surgery in more sites of care, today announced that it has received FDA 510(k) clearance for the use of its DEXTER® Robotic Surgery System in adult cholecystectomy (gallbladder removal). This milestone represents the second approved indication in the US, following De Novo clearance for inguinal hernia repair in Q4 2024.
“Cholecystectomy is a key procedure in general surgery, with approximately one million cases performed annually—of which 60 percent are performed in outpatient settings,” said Greg Roche, CEO of Distalmotion. “With indications for inguinal hernia repair and now cholecystectomy, we’re meaningfully building the reach of DEXTER in the US so that more surgical teams and patients will benefit from robotic surgery. Our mission remains focused on empowering access to robotics with the right robot for the right site of care.”
As one of the most frequently performed general surgeries in the United States, cholecystectomy is predominantly carried out in hospital outpatient departments and ambulatory surgery centers (ASCs). As more soft tissue procedures migrate to these settings, there is growing demand for robotic solutions that deliver enhanced dexterity, precision, and surgeon ergonomics—without compromising on flexibility, efficiency, or cost. Purpose-built for outpatient settings, DEXTER features a small, mobile footprint and integrates seamlessly into existing workflows to simplify operations and support high-volume procedures.
Building on its growing footprint in the US and Europe, DEXTER has been used in 2,000 procedures across more than thirty procedure types in general, gynecological, colorectal, and urological surgery. Distalmotion continues to expand access to robotic surgery in the US, with the completion of its pivotal HYPER study (NCT06473675) for benign hysterectomy and ongoing patient enrollment in its sacrocolpopexy clinical trial.
Note: The DEXTER Robotic Surgery System is currently authorized for use in adult inguinal hernia repair and cholecystectomy in the United States.
About DEXTER
The DEXTER® Robotic Surgery System is a soft tissue surgical robot that uniquely simplifies operations to make the benefits of wristed robotics accessible in any operating room (OR). DEXTER comes with a suite of fully wristed single use robotic instruments that enhance dexterity and precision.
A small, mobile footprint allows DEXTER to integrate into any size OR, without modifications, and to be easily maneuvered between rooms to optimize efficiency.
The sterile console supports flexible surgical workflows by positioning the surgeon close to the patient for quick bedside access, seamless transitions between laparoscopic and robotic techniques as desired, and enhanced communication with OR teams.
DEXTER open architecture enables compatibility with existing and future OR technologies, including visualization systems and advanced devices, for cost effective supply chain operations.
Its instinctive design ensures an efficient, effective learning curve for setup and use.
Indications for Use:
Europe: The DEXTER® Robotic Surgery System is intended to assist in the accurate control of robotic instruments during urologic laparoscopic surgical procedures, general laparoscopic surgical procedures, and gynecologic laparoscopic surgical procedures.
US: The DEXTER® Robotic Surgery System is intended for use in laparoscopic inguinal hernia repair and cholecystectomy. The system is indicated for adult use, defined as 22 years old and older.