Surgical Robotics Technology
Distalmotion has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection for the DEXTER® Robotic Surgery System.
This is the second US clearance for DEXTER in gynecology and the fourth overall, including general surgery indications for inguinal hernia repair and cholecystectomy. This latest clearance adds to the previous gynecology clearance, which included hysterectomy and salpingo-oophorectomy.
In ambulatory surgery centers (ASCs), where efficiency is critical, these additional procedures enable administrators to expand their gynecologic surgery service line while meeting both the demand for robotics in women’s health and efficiency metrics to maximize system utilization and increase throughput. With DEXTER, surgeons can now treat their 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.”
In parallel with this commercial expansion, Distalmotion continues to advance its clinical pipeline with its US Investigational Device Exemption (IDE) study for DEXTER in myomectomy.
With more than 4,000 patients treated with DEXTER, Distalmotion continues to advance its mission to expand access to robotic surgery across high-volume outpatient procedures.
Source: Distalmotion
