Monogram Technologies, the surgical robot developer being acquired by Zimmer Biomet, said it completed the first fully autonomous saw-based robotic knee replacement on a patient.
The procedure, at the Krishna Shalby Hospital in Ahmedabad, India, was performed Saturday as part of a clinical trial for Monogram’s mBôs TKA robotic system. The study will evaluate the safety and effectiveness of the system in 102 total knee replacement procedures at sites across India, and include three months of clinical follow-up.
Monogram Founder and Chief Medical Officer Douglas Unis said the procedure showed that robots can be tools for performing better knee replacements.
“Based on years of evaluating technology, watching this surgery was the final validation I needed to know with certainty that we have a groundbreaking product,” Unis said in a statement. “It was incredible that there was so little stress, given the level of autonomy and first-time use on a living person. It was flawless.”
Monogram received 510(k) clearance from the Food and Drug Administration for its semi-autonomous mBôs TKA system in March. Zimmer Biomet is spending about $177 million to buy Monogram.
Stereotaxis electrophysiology mapping catheter wins clearance
Stereotaxis said it gained FDA 510(k) clearance for a robotically navigated electrophysiology mapping catheter to treat cardiac arrhythmias.
The device, which is compatible with the company’s robotic magnetic navigation systems, uses 20 electrodes to collect real-time data for faster and more precise mapping of complex heart anatomy.
Daniel Cooper, director of the Electrophysiology Lab at Washington University, said the catheter will help physicians create more accurate and detailed maps of complex arrhythmias.
„The ability to combine high-density mapping with robotics is an exciting long-awaited milestone for the community of robotic electrophysiologists and the broader EP field,“ Cooper said in a statement.
A 510(k) submission for Sterotaxis’ latest robotic system, the GenesisX, is currently under review by the FDA, a company spokesperson told MedTech Dive in an email. GenesisX received Europe’s CE mark last year.
