Welcome to our dedicated page for Monogram Technologies news (Ticker: MGRM), a resource for investors and traders seeking the latest updates and insights on Monogram Technologies stock.
Monogram Technologies Inc. Common Stock (NASDAQ: MGRM) is a forward-thinking medical technology company specializing in the development of AI-driven robotic systems and patient-specific orthopedic implants. Formerly known as Monogram Orthopaedics Inc., the company aims to revolutionize reconstructive joint procedures through the integration of 3D printing, advanced machine vision, and next-generation robotics.
Monogram Technologies' flagship product, the mBŏs precision robotic surgical system, is designed to autonomously perform high-precision insertions of FDA-cleared press-fit implants. The system integrates automated digital image analysis algorithms and machine learning to deliver scalable, patient-specific load-bearing joint replacements. Their innovations are set to transform knee replacement surgeries by offering minimally invasive procedures that promise better-fitting and bone-sparing implants.
The company’s current and upcoming product lines include robotic surgical equipment, related software, orthopedic implants, tissue ablation tools, and navigation consumables. They are also in the verification and validation phase for their robotic products, aiming for a 510(k) submission to the FDA in the second half of 2024.
Recently, Monogram achieved significant milestones, including the delivery of their first surgical robot to a major global distributor, marking their entry into commercial revenues. The company's mBŏs robot addresses a major gap in the $19.4 billion knee replacement market, which still relies heavily on manual procedures for approximately 88% of surgeries.
Monogram Technologies continues to advance its commercialization roadmap while exploring new applications for its technology. Their mVision navigation system, aimed at eliminating cart-based tracking and minimizing surgical time, represents another leap forward in orthopedic robotics. As part of their growth strategy, Monogram is also actively seeking partnerships with independent distributors to further expand its market reach.
Visit www.monogramorthopedics.com for more information and the latest updates on their developments.
Monogram Orthopaedics Inc. provided an update regarding its mBôs surgical system regulatory path after a meeting with the FDA, revealing accelerated 510(k) submission plans for early second half of 2024. The FDA feedback on the Q1 2023 submission was positive, supporting a least burdensome approach to clinical data acquisition. Management aims to conduct an OUS clinical trial, estimating costs at $1.5M, to support post-launch marketing. Monogram anticipates leveraging OUS clinical data and an accommodating FDA stance towards it to expedite technology pipeline development, including mVision tracking solution. Verification and Validation testing nearing completion in Q2 2024, with a 510(k) submission expected in late 2024. The company's modified mBôs system design aims to minimize the risk of FDA clinical data requests. Various tests and validations are progressing well, with strategic engagements with external partners, including MCRA, aiding in regulatory strategy execution.
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