Distalmotion has received 510(k) approval from the US Food and Drug Administration (FDA) for its Dexter Robotic Surgery System for use in adult cholecystectomy procedures in the US.
It is the second indication for the Dexter system in the US, following the FDA De Novo approval for inguinal hernia repair, granted in the fourth quarter of 2024.
Cholecystectomy, a common general surgery in the US, is increasingly performed in hospital outpatient departments and ambulatory surgery centres (ASCs).
Designed specifically for outpatient environments, the Dexter system features a compact, mobile design that integrates easily into existing workflows.
The system has been used in 2,000 procedures across over 30 types of surgeries, including general, gynaecological, colorectal, and urological, in both the US and Europe.
Distalmotion CEO Greg Roche said: “Cholecystectomy is a key procedure in general surgery, with approximately one million cases performed annually, of which 60% are performed in outpatient settings.
“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.”
The Dexter Robotic Surgery System is a soft tissue surgical robot that simplifies operations, making wristed robotics accessible in any operating room (OR).
It includes fully wristed single-use robotic instruments that improve dexterity and precision.
Its small, mobile footprint allows easy integration into ORs of any size without modifications and facilitates movement between rooms to optimise efficiency.
The sterile console of the Dexter system supports flexible surgical workflows, positioning the surgeon close to the patient for quick access, seamless transitions between laparoscopic and robotic techniques, and improved communication with OR teams.
Its open architecture enables compatibility with existing and future OR technologies, ensuring cost-effective supply chain operations.
Currently, Dexter is indicated for assisting in the accurate control of robotic instruments during urologic, general, and gynaecologic laparoscopic surgical procedures in Europe.
In the US, the system is intended for laparoscopic inguinal hernia repair and cholecystectomy for adults aged 22 and older.
Distalmotion is expanding access to robotic surgery in the US by completing its HYPER study for benign hysterectomy and continuing patient enrolment in its sacrocolpopexy trial.
