
Monogram Technologies, a leader in the field whose knee replacement system received FDA approval on March17, and Vicarious Surgical, which is developing a single-port robotic system for abdominal procedures.
Both companies are pushing the limits of robotics surgery, promising more personalized treatments for patients in the near future. Monogram Technologies, headquartered in Austin, Texas, has received FDA 510(k) clearance for its mBôS Total Knee Arthroplasty (TKA), also known as robotic knee replacement system.
Benefits of Robotic Knee Replacement Surgery
The mBôS system offers numerous advantages of knee replacement robotic surgery, such as enhanced precision, fewer complications, and quicker recovery time, and by employing advanced robotics, the system accurately positions knee implants, leading to better and durability.
The mBôS system includes a private alignment technique that helps surgeons make real-time adjustments. This system is a highly developed solution in the total knee replacement systems market.
Knee replacement by robot also has its disadvantages and benefits that need to be balanced. For example, higher initial costs and the need for specialized training for surgeons. However, as technology advances, these advantages and disadvantages of robotic knee replacement hurdles will most likely minimize with greater availability of robot assistant procedures to a larger population, eventually resulting in more machine-led procedures.
Vicarious Surgical Faces Delays
Vicarious Surgical, which is developing a single-port robotic system for abdominal surgery, is facing delays in clinical trials and FDA de novo submission due to supply chain issues, affecting the production of its Version 1.0 robots.
As a result, Vicarious predicts welcoming its first clinical patients by the fourth quarter of 2025 and its FDA submission now is expected to be pushed back to late 2026.
Despite the delay, Vicarious Surgical is optimistic about the future of its robotic knee replacement system. The single-port system will reduce complications for ventral hernia procedures due to its minimally invasive approach, leading to faster recovery and fewer complications compared to open surgery.
Amid these delays, Vicarious Surgical is reassessing its financial strategy. BTIG analyst Ryan Zimmerman said the company may need to reduce cash burn or raise capital to be able to sustain its development process.
Final Thoughts
The delay in Vicarious Surgical’s knee replacement system FDA clearance highlights a dilemma within the MedTech industry which is the tension between quick innovation and strict safety testing. The delays hinder the rollout of new technology, potentially delaying patient access to new solutions that have the ability to treat them better.
So, who is right? The solution likely lies in balancing innovation with thorough testing to ensure that when new technology emerges, it is safe and effective to be used by patients. Eventually, while frustration is brought on by delays, they are absolutely critical to protecting public health.
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