Momentis Surgical 的 Anovo 手术机器人获 FDA 510(k) 多孔手术配置许可

New clearance enables surgeons to perform natural orifice, single-port, and multiport procedures on a single flexible robotic platform, expanding system modularity while reducing the need for multiple robotic systems.
FORT LAUDERDALE, Fla. and TEL AVIV, Israel, July 23, 2026 /PRNewswire/ -- Momentis Surgical today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the multiport configuration of the Anovo® Surgical System, expanding the versatility of the company's flexible robotic surgery platform. The clearance expands the platform beyond its cleared natural orifice and single-port indications, making Anovo the first robotic surgical system capable of supporting all three surgical access approaches on a single platform.
The clearance allows surgeons to utilize Anovo's proprietary internally articulated humanoid-inspired shoulder-, elbow-, and wrist-like robotic instruments in a conventional multiport approach while leveraging the same core platform previously cleared for natural orifice and single-port/single-site procedures. This allows a general surgeon to choose between a single-site and multiport approach for ventral hernia repair and adds the multiport option to single-site and transvaginal approaches for gynecologic surgeons. With this milestone, Anovo becomes the only robotic surgical platform capable of supporting multiple surgical access strategies without requiring separate robotic systems.
"From the beginning, our vision was never to build another robotic system that simply replicated laparoscopy," said Dvir Cohen, Chief Executive Officer of Momentis Surgical. "We set out to rethink robotic surgery from the inside out. This clearance represents another important step toward that vision by giving surgeons the flexibility to choose the appropriate surgical approach for the patients' benefit while using the same compact robotic platform."
Beyond its strengths in natural orifice and single-site procedures, Anovo brings its flexible instruments to multiport robotic surgery to overcome key challenges in this field. Conventional robotic systems rely on rigid, straight instruments that generate large external fulcrum motions, driving bulky robotic arms and increasing the risk of arm collisions. Anovo's internally articulated instruments shift the point of articulation inside the patient, minimizing external arm movement while maintaining true 360-degree dexterity at the surgical site. The result is a more compact robotic architecture with fewer of the limitations inherent to conventional systems.
The clearance expands the modularity of the Anovo platform by allowing hospitals and ambulatory surgery centers to offer multiple robotic surgery approaches without investing in multiple specialized systems. The platform's compact footprint, simplified workflow, and lower capital requirements are designed to improve access to robotic surgery in both hospital and outpatient settings.
"The future of robotic surgery will not be defined by a single access technique," said Maurice R Ferré, MD, Chairman of Momentis Surgical, Chairman and CEO of Insightec and Co-Founder and former CEO of MAKO Surgical. "Surgeons need the flexibility to select the best approach for each patient. With this clearance, Anovo becomes a truly adaptable platform capable of supporting natural orifice, single-port, and multiport procedures within one unified robotic ecosystem." Until now, hospitals have largely had to choose robotic systems based on surgical approach. This clearance provides the modularity of natural orifice, single-site, and multiport surgery for the indicated procedures on a single flexible robotic platform.
The clearance builds on a series of regulatory and commercial milestones for Momentis, including the first FDA De Novo authorization for a robotic transvaginal surgical system, subsequent clearances for single-site transabdominal ventral hernia repair, and the recent addition of robotic camera control. Commercial experience with the second-generation Anovo platform has demonstrated strong surgeon adoption, with robotic surgeons transitioning most of their benign gynecologic procedures from legacy robotic systems to Anovo.
The company expects the expanded indication to accelerate commercialization by broadening the platform's clinical applicability while preserving the advantages of its flexible robotics architecture.
About Momentis Surgical®
Momentis Surgical is redefining robotic surgery through flexible robotics. The company's Anovo® Surgical System features proprietary internally articulated robotic instruments that deliver true 360-degree dexterity through a compact platform designed for natural orifice, single-port, and multiport minimally invasive surgery. By combining advanced flexibility with a smaller footprint and attractive economics, Momentis is expanding access to robotic surgery across hospitals and ambulatory surgery centers. For more information, visit: https://www.momentissurgical.com/.
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SOURCE Momentis Surgical