Monogram Technologies Secures Approval for Robotic Knee Surgery Clinical Trial in India

By Advos

TL;DR

Monogram Technologies gains approval in India for clinical trial with Shalby Limited, paving the way for a major milestone and potential global orthopedic standard elevation.

Monogram's mBôs TKA system receives approval in India for a 102-patient clinical trial evaluating safety and effectiveness in robotic total knee replacement surgeries.

Monogram's AI-driven robotics aim to improve orthopedic surgery, offering personalized knee implants for patients and potentially raising global orthopedic standards.

Monogram Technologies' approval for a clinical trial in India marks a significant advancement in AI-driven robotics for orthopedic surgery, shaping the future of healthcare.

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Monogram Technologies Secures Approval for Robotic Knee Surgery Clinical Trial in India

Monogram Technologies, an AI-driven robotics company, has received approval from India's Central Drugs Standard Control Organization to initiate a comprehensive clinical trial for its robotic total knee replacement system. The 102-patient multi-center study, conducted in partnership with Shalby Limited, will evaluate the safety and effectiveness of the company's mBôs TKA system using a Consensus CKS implant.

The clinical trial represents a critical milestone for Monogram Technologies in expanding its orthopedic surgical technology into the Indian market. By deploying full-time staff to support training and execution, the company aims to ensure rigorous implementation of the study protocol. Surgeries are expected to commence within 90 business days of the regulatory approval.

CEO Benjamin Sexson characterized the approval as a major advancement toward commercial launch, highlighting the potential impact of the company's innovative robotic surgical approach. The trial's design includes a three-month clinical follow-up across multiple Indian sites, which will provide comprehensive data on the system's performance and patient outcomes.

This clinical trial could potentially demonstrate the advantages of Monogram's AI-driven robotic surgical technology, which aims to create more personalized knee implants. The technology combines advanced machine vision, artificial intelligence, and next-generation robotics to potentially improve surgical precision and patient recovery.

The study's success could have significant implications for orthopedic surgery, potentially setting new standards for knee replacement procedures. By focusing on bone-sparing techniques and personalized implant fitting, Monogram Technologies is positioning itself at the forefront of surgical innovation in the orthopedic medical field.

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