Robotic surgery’s growing popularity has attracted startups pursuing segments of the market across numerous medical specialties. Here are the latest developments at two companies looking to make a difference in the field.
Monogram’s robotic knee system earns FDA 510(k)
Monogram Technologies received Food and Drug Administration 510(k) clearance for its mBôS TKA System for total knee replacements and will now work toward commercializing the system, the Austin, Texas-based company said Monday.
Monogram aims initially to place the robot with surgeons who are key opinion leaders in strategic geographies as it establishes clinical experience and demonstrates the platform in real-world settings. It plans to integrate recent upgrades to the robot’s cutting system and other enhancements into the cleared mBôs device over the coming months.
CEO Benjamin Sexson told MedTech Dive in 2023 that Monogram’s robot uses a personalized alignment approach that allows surgeons to make precise adjustments during procedures, leading to greater patient satisfaction with the outcome of their knee replacement. The goal is better-fitting knee implants.
The platform is built to eventually support orthopedic applications beyond knee replacement.
Monogram, which went public in May 2023, is also working toward submissions for more clinical applications and hopes to obtain regulatory clearance to begin trials in India.
The company said it believes the robotic-assisted joint reconstruction market is underpenetrated, with room for innovation and growth.
Vicarious Surgical delays de novo submission
Vicarious Surgical, which is developing a single-port robotic system intended to minimize patient complications in abdominal procedures, said Monday that supply chain challenges would delay the start of its clinical trial and de novo submission.
“We still expect to treat our first clinical patients this year,” CEO Adam Sachs told analysts on an earnings call. “However, it will be closer to year-end. Consequently, we now expect our de novo submission to be late in 2026.” Vicarious previously targeted an early to mid-2026 submission.
President Randy Clark said material procurement challenges at key suppliers delayed the delivery of components needed to complete production of its Version 1.0 robots.
Vicarious plans to file a de novo classification application with the FDA for use of the robot in ventral hernia procedures as its first indication.
BTIG analyst Ryan Zimmerman, in a note to clients Monday, said Vicarious will need to reduce its cash burn or find more financing sources given the extended development timeline. “None of this is easy in this environment,” Zimmerman added.
Waltham, Massachusetts-based Vicarious recently hired Sarah Romano as its new CFO. Romano will begin April 1, the same day Chief Operating Officer John Mazzola plans to retire.
