Distalmotion has received FDA approval for its Dexter Surgical Robot, allowing it to enter the U.S. outpatient market.
Vaud-based medtech company Distalmotion has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its Dexter Surgical Robot. This milestone allows Distalmotion to market Dexter for adult inguinal hernia repair in the United States, marking a significant entry into the U.S. ambulatory and ambulatory surgery center (ASC) market. With more than 1,300 patients successfully treated in Europe, Dexter is well positioned to bring robotic-assisted surgery to high-volume outpatient settings in the U.S.
Distalmotion’s Dexter system addresses growing demands in ASCs by offering a compact, mobile robotic platform that integrates seamlessly into existing operating room workflows. Its unique design allows surgeons flexibility, switching effortlessly between robotic and manual techniques and offering an “open” platform compatible with third-party laparoscopic tools and imaging systems. According to Dr. William Hope, General Surgery Residency Program Director at Novant Health, Dexter’s accessibility and ergonomic design “will undoubtedly enable more patients to benefit from robotic-assisted surgery.”
Dexter’s streamlined form factor and single-use instrument options make it particularly advantageous for outpatient settings where cost effectiveness and workflow efficiency are priorities. The system’s intuitive console gives surgeons direct access to the patient for greater control and efficiency. Dr. Garth Jacobsen, Director of Hernia Surgery at UC San Diego, highlighted Dexter’s ease of use, calling it “more ergonomic and operatively efficient than current generation platforms,” while Dr. Ryan Broderick of UC San Diego noted its suitability for outpatient procedures, as Dexter’s design “enables the ideal robot for outpatient sites of care.”
The FDA’s De Novo authorization positions Dexter as a versatile solution for ASCs, aligning with Distalmotion’s recent strategic moves. In September, the company secured funding from Revival Healthcare and the Swiss Entrepreneurs Fund to drive Dexter’s global expansion, with sights set on the U.S. market. This funding is further supported by a partnership with Proximie, enabling digital collaboration among surgeons worldwide.
