FDA grants De Novo marketing authorization for the Distalmotion Dexter® Surgical Robot
31.10.2024
Distalmotion's Dexter Surgical Robot opens an entirely new era for soft tissue robotics in the outpatient setting and ambulatory surgery centres that will have an immediate benefit for patients.
 Distalmotion's team
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Distalmotion has been granted De Novo approval by the U.S. Food and Drug Administration (FDA) to market the Dexter Surgical Robot for adult inguinal hernia repair. This significant milestone marks another step forward in Distalmotion’s mission to empower robotic surgery excellence by expanding access and improving care with robotic-assisted surgery in the hospital outpatient and ambulatory surgery centers (ASC’s) where over 90% of inguinal hernia repairs are currently performed in the United States. With more than 1,300 patients successfully treated in Europe, Distalmotion’s extensive experience has paved the way for bringing this innovation to the U.S. market.
Distalmotion is focused on developing a robotic platform for high-volume procedures and bringing the benefits of robotic-assisted surgery to outpatient settings where demand for cost-effective and efficient solutions continues to grow (7% ASC market CAGR). Dexter’s mobile design, combined with its small form factor, makes it particularly well-suited to these environments, allowing hospitals and ASCs to optimize resources while still accessing the latest technologies and best-in-class surgical tools.
Dexter seamlessly integrates into existing operating workflows and is fully compatible with current operating room equipment, protecting hospitals' existing investments. Additionally, its single-use instruments remove the complexities of reprocessing, further enhancing workflow efficiency. Dexter’s design enables direct and quick access to the patient from the sterile surgeon console, allowing surgeons the flexibility to choose the best technique for each step of the procedure. Dexter is designed to be the "surgeon’s robot" that provides the physician complete control of the procedure to optimize patient outcomes.
Distalmotion won the final stage of Venture Kick in 2012, was ranked among the TOP 100 Swiss Startups from 2013 to 2017 as well as among the TOP 100 Scale-ups in 2021 and 2022.
Distalmotion is focused on developing a robotic platform for high-volume procedures and bringing the benefits of robotic-assisted surgery to outpatient settings where demand for cost-effective and efficient solutions continues to grow (7% ASC market CAGR). Dexter’s mobile design, combined with its small form factor, makes it particularly well-suited to these environments, allowing hospitals and ASCs to optimize resources while still accessing the latest technologies and best-in-class surgical tools.
Dexter seamlessly integrates into existing operating workflows and is fully compatible with current operating room equipment, protecting hospitals' existing investments. Additionally, its single-use instruments remove the complexities of reprocessing, further enhancing workflow efficiency. Dexter’s design enables direct and quick access to the patient from the sterile surgeon console, allowing surgeons the flexibility to choose the best technique for each step of the procedure. Dexter is designed to be the "surgeon’s robot" that provides the physician complete control of the procedure to optimize patient outcomes.
Distalmotion won the final stage of Venture Kick in 2012, was ranked among the TOP 100 Swiss Startups from 2013 to 2017 as well as among the TOP 100 Scale-ups in 2021 and 2022.