Welcome to our dedicated page for Monogram Orthopaedics news (Ticker: MGRM), a resource for investors and traders seeking the latest updates and insights on Monogram Orthopaedics stock.
Monogram Technologies Inc (NASDAQ: MGRM) pioneers AI-driven orthopedic solutions combining surgical robotics, 3D printing, and machine vision. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's innovative approaches to joint replacement technology.
Access timely announcements including regulatory submissions, clinical trial progress, and strategic partnerships. Our curated collection features earnings reports, product development milestones, and analyses of the company's unique robotic surgical ecosystem designed for precision implant placement.
Key updates cover advancements in autonomous surgical systems, FDA clearance processes, and collaborations with medical institutions. Bookmark this page for verified information about Monogram's integration of digital imaging analytics, and bone-sparing surgical techniques that aim to redefine orthopedic care standards.
Monogram Orthopaedics Inc. has engaged a global Contract Research Organization (CRO) to oversee its clinical trial activities for its mBôs Total Knee Arthroplasty (TKA) System outside the U.S., aiming to accelerate its product pipeline development and commercialization opportunities. The CRO will submit the clinical trial data to local regulators and has experience with successful FDA submissions. Monogram plans to conduct a multi-center TKA clinical trial with the mBôs TKA System using the cemented version of its FDA-cleared mPress TKA implant. The company expects to complete enrollment and study execution expeditiously, leveraging the clinical data for post-launch marketing and international clearance. The clinical trial design follows FDA guidance and regulations for investigations conducted outside the U.S., ensuring compliance with GCP guidelines and other regulatory requirements.
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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