Monogram Technologies (NASDAQ: MGRM), an AI-driven robotics company transforming orthopedic surgery, has received approval from India’s Central Drugs Standard Control Organization to import its mBôs TKA system and begin a 102-patient, multi-center clinical trial in partnership with Shalby Limited (NSE: SHALBY). The study will evaluate the safety and effectiveness of Monogram’s robotic total knee replacement system using a Consensus CKS implant and include three-month clinical follow-up across multiple Indian sites. Monogram will deploy full-time staff to support training and execution, with surgeries expected to begin within 90 business days. CEO Benjamin Sexson called the approval a major milestone toward commercial launch, while partners from Reliance Life Sciences and Shalby praised the trial’s potential to elevate global orthopedic standards.
To view the full press release, visit https://ibn.fm/RX3Iy
About Monogram Technologies Inc.
Monogram Technologies (NASDAQ: MGRM) is an AI-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI and next-generation robotics.
Monograms mBôs precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goal is well balanced, better-fitting bone sparing knee replacements. The Company initially intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. Other clinical and commercial applications for the mBôs with mVision navigation are also being explored.
Monogram has obtained FDA clearance for mPress implants and applied for 510(k) clearance for its robotic products. The Company is required to obtain FDA clearance before it can market its products. Monogram cannot estimate the timing or assure the ability to obtain such clearances.
The Company believes that its mBôs precision robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for patients, resulting in well balanced better-fitting knee replacements with bone sparing implants. Monogram anticipates that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.
For more information, please visit www.monogramtechnologies.com.
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