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Monogram Technologies Announces World's First Fully Autonomous Saw-Based Robotic Knee Replacement Surgery
Globenewswire· 2025-07-29 13:30
Core Viewpoint - Monogram Technologies Inc. has successfully completed the world's first fully autonomous saw-based robotic total knee arthroplasty (TKA) surgery on a live patient, marking a significant milestone in orthopedic surgery innovation [1][4][12]. Company Overview - Monogram Technologies Inc. is an AI-driven robotics company focused on revolutionizing orthopedic surgery, with a commitment to improving human health through advanced technologies [14]. - The company has developed the mBôs TKA System, which is designed to enhance the safety and effectiveness of knee replacement procedures [3][11]. Clinical Trial Details - The groundbreaking procedure took place at Krishna Shalby Hospital in Ahmedabad, India, as part of a multi-center clinical trial involving 102 total knee replacement procedures [2][3]. - The trial aims to evaluate the safety and effectiveness of the Monogram TKA System, with a three-month clinical follow-up period [3]. Regulatory Approvals - Monogram received regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) to import its mBôs TKA system for clinical investigation [3]. - The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Monogram's semi-autonomous TKA System, further validating its market readiness [12]. Strategic Partnerships - Monogram has partnered with Shalby Limited, one of the largest orthopedic hospital groups globally, to support the clinical investigation of the TKA System [11]. - Shalby Hospitals aims to lead innovation in joint replacement surgeries and has expressed strong support for the introduction of Monogram's robotic system [12]. Impact and Future Outlook - The successful execution of the autonomous knee replacement procedure is expected to have a significant positive impact on the standard of care in orthopedic medicine [4][9]. - Company executives have expressed confidence that the Monogram TKA System will lead to improved clinical outcomes and efficiency in knee replacement surgeries globally [8][9].