Monogram Technologies Inc., a leading AI-driven robotics company based in Austin, Texas, has recently submitted a 510(k) premarket filing to the U.S. Food and Drug Administration (FDA) for its innovative mBôs TKA System. This groundbreaking system is designed to revolutionize orthopedic surgery by leveraging precision robotic technology to enhance patient outcomes and improve overall healthcare.
The application for FDA clearance was officially submitted on July 19, 2024, and has successfully passed the FDA Administrative Review. The next phase involves substantive review by the FDA, with a decision expected within 90 days of the initial submission. However, the process may be temporarily paused if additional information is requested by the regulatory body.
Ben Sexson, the CEO of Monogram Technologies, expressed his enthusiasm for this significant milestone, stating, “The 28,214-page submission is the culmination of over eight years of dedicated effort and rigorous testing. This FDA submission for the mBôs TKA System marks a pivotal moment for Monogram as we continue our mission to advance human health through cutting-edge robotic surgical technology.”
Acknowledging the hard work and dedication of the Monogram team, Sexson highlighted key individuals such as Kamran Shamaei and engineering leadership, Muhammad Afnan, Pedro Alfonso, Gerardo Gonzalez, Daniel Grunden, Ani Nayak, and Nisha Patel. He also extended his gratitude to the company’s founder and Chief Medical Officer, Dr. Doug Unis, for his visionary leadership in driving the development of the mBôs TKA System.
Dave McGurl, Vice President of Regulatory Affairs at MCRA, commended the thoroughness of Monogram’s FDA submission, stating, “We believe that this is a very strong application. The team has demonstrated a high level of commitment and expertise, supported by comprehensive testing and documentation. We are confident in the potential for successful clearance and commercialization of the mBôs TKA System.”
The recent FDA feedback received by Monogram following a pre-submission request and teleconference meeting has further informed the development of the mBôs TKA System verification test plan. This feedback, along with proposed clinical trial protocols, is expected to enhance the overall submission process and facilitate a successful 510(k) clearance for the innovative robotic surgical system.
Kamran Shamaei, Chief Technology Officer at Monogram, emphasized the company’s unwavering commitment to realizing their vision, stating, “We are dedicated to pushing the boundaries of technology and exploring new clinical applications for our precision robotic system. With a focus on AI-driven computer vision and safety-enhanced robotics, we believe the mBôs TKA System is well-positioned to meet the evolving needs of the orthopedic market.”
Leading orthopedic surgeons have also expressed their support for Monogram’s mBôs TKA System, citing its potential to revolutionize the field of orthopedic surgery. Dr. Fabio Orozco, President of Orozco Orthopaedics, praised the system’s emphasis on patient safety and accuracy, declaring his intention to support Monogram’s commercial launch once FDA clearance is obtained.
Similarly, Dr. Robert Jamieson, who participated in the Verification and Validation testing for the FDA submission, likened Monogram’s mBôs to a technological advancement in orthopedic surgery, emphasizing its transformative potential for the market. Dr. Jamieson’s endorsement further underscores the confidence in Monogram’s commitment to advancing patient care through innovative robotic technology.
Dr. Joey Romero, a proponent of robotic-assisted surgery for arthroplasty, highlighted the importance of precision and patient-specific customization in improving surgical outcomes. His collaboration with Monogram during the development and testing phases of the mBôs TKA System reflects the strong partnership between medical professionals and technology innovators in driving healthcare advancements.
Dr. Doug Unis, founder and Chief Medical Officer of Monogram, expressed his anticipation for using the mBôs TKA System in clinical practice, underscoring the collaborative efforts of the Monogram team in bringing this innovative technology to fruition. The company’s Chief Financial Officer, Noel Knape, anticipates that the FDA submission will open up funding opportunities and attract institutional support as Monogram continues to advance its milestones.
Monogram Technologies’ mBôs precision robotic surgical system represents a significant leap forward in orthopedic robotics, combining AI, machine vision, and next-generation robotics to deliver patient-optimized orthopedic implants. With a focus on personalized care, precision, and safety, the mBôs TKA System is poised to revolutionize orthopedic surgery and set new standards for patient outcomes and quality of care.
As Monogram awaits FDA clearance for its innovative robotic system, the company remains committed to advancing the field of orthopedic surgery and improving the lives of patients through cutting-edge technology. With a dedicated team of experts, strong industry partnerships, and a clear vision for the future, Monogram Technologies is poised to lead the way in shaping the future of healthcare through innovation and excellence.