Distalmotion Earns Expanded FDA Nod for Dexter Surgical Robot in Gynecology

Distalmotion has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Dexter robotic surgery system to be used in sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection.

This marks the second FDA nod for Dexter in gynecology and fourth overall, including general surgery indications for inguinal hernia repair and cholecystectomy. The latest clearance adds to the previous gynecology clearance, which included hysterectomy and salpingo-oophorectomy.

The company said in ambulatory surgery centers (ASCs), these additional procedures let administrators expand their gynecology service line while meeting the demands for robotics in women’s health and efficiency metrics to maximize system utilization and increase throughput. Using Dexter, surgeons can treat patients robotically across diverse gynecologic conditions in a more convenient, lower cost site of care.

“Securing FDA clearance for these additional GYN indications is another important milestone for the DEXTER program,” said Greg Roche, CEO of Distalmotion. “By enabling a comprehensive GYN service line, we are empowering care teams to maximize their workflows and deliver the combined benefits of robotics and same-day care to a broader patient population.”

The company also continues to advance its clinical pipeline with a U.S. investigational device exemption (IDE) study for Dexter in myomectomy. Over 4,000 patients have been treated with Dexter as the company advances its mission to grow access to robotic surgery across high-volume outpatient procedures.