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29.10
2024

FDA Grants De Novo Marketing Authorization for the Distalmotion Dexter Surgical Robot

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 percent 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 continue to grow (7 percent ASC market CAGR). Dexter’s mobile design, combined with its small form factor, make 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.

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