Distalmotion has grabbed hold of a de novo clearance for its Dexter surgical robot, a system designed for hospitals as well as ambulatory surgery centers.
The robotic assistant was cleared by the FDA for use in inguinal hernia repairs, an abdominal procedure that the company estimates is performed more than 90% of the time in the outpatient setting within the U.S.
“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,” Distalmotion CEO Greg Roche said in a statement. “Our goal is to enhance existing practices with robotics that support—not disrupt—the way surgical teams operate.”
To that end, Dexter is designed to be compatible with existing instruments and includes single-use equipment that helps avoid the need for reprocessing and sterilizing hardware.
The mobile, cart-based system is also built to offer what Distalmotion has described as a hybrid approach to surgery, allowing clinicians to swap between the device’s two robotic arms and hand-operated laparoscopic tools.
The platform has been available in Europe since late 2020, for procedures in gynecology, urology and general surgery; the Lausanne, Switzerland-based company said Dexter has been used to treat more than 1,300 patients.
Distalmotion previously raised $150 million in April 2023 to help bring the system to U.S. shores, via a fundraising round led by Revival Healthcare Capital. The company had also picked up $90 million in venture capital just over a year prior.