FDA Clears Momentis Surgical’s Anovo System for Multiport Surgery
Momentis Surgical has received the U.S. Food and Drug Administration (FDA) 510(k) clearance for the multiport configuration of the Anovo Surgical System, expanding the platform beyond its previously cleared natural orifice and single-port indications. The clearance makes Anovo the first robotic surgical system capable of supporting all three surgical access approaches — natural orifice, single-port, and multiport — on a single platform.
The clearance allows surgeons to utilize Anovo’s internally articulated humanoid-inspired robotic instruments in a conventional multiport approach while leveraging the same core platform previously cleared for natural orifice and single-port procedures. This enables a general surgeon to choose between a single-site and multiport approach for ventral hernia repair and adds the multiport option to existing approaches for gynecologic surgeons. The platform’s internally articulated instruments shift the point of articulation inside the patient, minimizing external arm movement while maintaining 360-degree dexterity at the surgical site, resulting in a more compact architecture with fewer 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. 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.
Dvir Cohen, Chief Executive Officer of Momentis Surgical, said the company’s vision was never to build another robotic system that simply replicated laparoscopy, but to rethink robotic surgery from the inside out. He noted that 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.
Maurice R Ferré, MD, Chairman of Momentis Surgical, said the future of robotic surgery will not be defined by a single access technique, and surgeons need the flexibility to select the best approach for each patient. He noted that 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 multiple approaches on a single flexible robotic platform for the indicated procedures. 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. The clearance builds on a series of regulatory 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.
