Distalmotion 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.
The company says this milestone marks 'another step forward' in its mission to empower robotic surgery excellence by expanding access and improving care with robotic assisted surgery in the hospital outpatient and ambulatory surgery centres (ASC's) where over 90% of surgeries are performed in the United States. Distalmotion says it is focused on developing a robotic platform for high-volume procedures and bringing the benefits of robotic-assisted surgery to outpatient settings. The company says that in these settings, demand for cost-effective and efficient solutions is growing.
"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," said Greg Roche, Distalmotion CEO.
"Our goal is to enhance existing practices with robotics that support, not disrupt, the way surgical teams operate." Read more: Surgical robot firm closes $90m financing round William Hope, MD, Associate Professor of Surgery, UNC Chapel Hill, General Surgery Residency Program Director, New Hanover Regional Medical Center (Novant Health) added: "Inguinal hernia repair is an excellent first indication for Dexter. Access to robots for these procedures has historically been a challenge.
Dexter's design will undoubtedly ena.