Autonomous Milestone Achieved by Monogram Robot; Stereotaxis Catheter Gains Approval
In a groundbreaking development, Monogram Technologies, a leading name in medical robotics, has successfully completed the world's first fully autonomous saw-based robotic total knee arthroplasty (TKA) procedure on a live patient on July 26, 2025, at Krishna Shalby Hospital in Ahmedabad, India[1][3][4].
This historical surgery was part of a clinical trial for Monogram's innovative mBôs TKA robotic system. The trial, which aims to evaluate the safety and effectiveness of the system in 102 total knee replacement procedures across multiple sites in India, includes a three-month postoperative follow-up period[1][2]. The trial received regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) to import the system for the study, and patient enrollment and initial surgeries were expected to begin shortly after July 2025[2].
Monogram has delivered training systems and conducted investigator meetings to support the clinical trial, with full-time staff deployed in India for assistance[2]. The mBôs TKA system had already received FDA 510(k) clearance for its semi-autonomous functionality in March 2025 in the United States, but full regulatory approvals for the fully autonomous system are still pending globally[1][3].
Meanwhile, another significant advancement in the medical robotics field is being made by Stereotaxis. The company is developing the GenesisX robotic system, which is intended for use in complex heart procedures. Stereotaxis' GenesisX robotic system received Europe's CE mark last year[5]. Recently, the company also gained FDA 510(k) clearance for a robotically navigated electrophysiology mapping catheter[6].
Daniel Cooper, director of the Electrophysiology Lab at Washington University, expressed excitement about the potential impact of the new catheter on the community of robotic electrophysiologists and the broader EP field. The catheter, compatible with Stereotaxis' robotic magnetic navigation systems, uses 20 electrodes to collect real-time data for faster and more precise mapping of complex heart anatomy[7].
As the world of medical robotics continues to evolve, these advancements promise to revolutionise surgical procedures, offering improved accuracy, precision, and patient outcomes. The clinical trials for both Monogram's mBôs TKA system and Stereotaxis' GenesisX robotic system are ongoing, with regulatory clearances and broad commercialization still in progress[1][2][3][4][5][6][7].
[1] Monogram Technologies. (2025). Monogram Technologies Completes First Fully Autonomous Robotic Knee Replacement Procedure. Business Wire. [2] Monogram Technologies. (2025). Monogram Technologies Announces First Fully Autonomous Robotic Knee Replacement Procedure in India. PR Newswire. [3] MedTech Dive. (2025). Monogram Technologies completes first fully autonomous robotic knee replacement. MedTech Dive. [4] Stereotaxis. (2025). Monogram Technologies Completes First Fully Autonomous Robotic Knee Replacement Procedure. Business Wire. [5] Stereotaxis. (2024). Stereotaxis Receives CE Mark for GenesisX™ Robotic System. Business Wire. [6] Stereotaxis. (2025). Stereotaxis Receives FDA 510(k) Clearance for Robotically Navigated Electrophysiology Mapping Catheter. Business Wire. [7] MedTech Dive. (2025). Stereotaxis gains FDA clearance for robotically-navigated EP mapping catheter. MedTech Dive.
- The success of Monogram Technologies' first fully autonomous robotic total knee arthroplasty (TKA) procedure is a significant leap in medical robotics, demonstrating the potential for innovation in healthcare.
- Monogram's mBôs TKA robotic system, currently under clinical trial, aims to prove its safety and effectiveness in 102 total knee replacement procedures.
- Regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) permitted the import of Monogram's system for the clinical trial.
- The mBôs TKA system had earlier received FDA 510(k) clearance for its semi-autonomous functionality in the United States.
- Stereotaxis is another company making strides in medical robotics, developing the GenesisX robotic system for complex heart procedures.
- Stereotaxis' GenesisX robotic system received Europe's CE mark last year, and recently, it gained FDA 510(k) clearance for a robotically navigated electrophysiology mapping catheter.
- Daniel Cooper, from the Electrophysiology Lab at Washington University, was excited about the potential impact of Stereotaxis' new catheter on the robotic electrophysiologists and broader EP field.
- The new catheter, compatible with Stereotaxis' robotic magnetic navigation systems, uses 20 electrodes to collect real-time data for faster and more precise mapping of complex heart anatomy.
- Both Monogram's mBôs TKA system and Stereotaxis' GenesisX robotic system are undergoing ongoing clinical trials, with regulatory clearances and broad commercialization still in progress.
- Advancements in medical robotics, such as those by Monogram Technologies and Stereotaxis, hold the promise of revolutionizing surgical procedures, improving accuracy, precision, and health outcomes, while also impacting the fields of finance, business, technology, health-and-wellness, and medical-conditions.
