The FDA previously granted marketing authorization for CMR’s first-generation Versius Surgical System in October 2024.
MMI earns FDA clearance for robotic soft tissue dissection tools
MMI’s dissection instruments are some of the smallest fully wristed robotic instruments designed for dissection in open microsurgery.
Wandercraft earns second FDA clearance for Atalante X exoskeleton
This clearance comes just a few short months after Wandercraft received expanded CE Mark certification for enhanced clinical features.
Medical Microinstruments completes first case in neurosurgical trial with MMI Symani system
Founded in 2015, MMI said it is developing robotic technology that pushes the limits of soft tissue open surgery.
Levita Magnetics’ MARS platform uses AI-guided autonomous camera in first surgery
By reducing manual camera control, the AI-guided MARS platform aims to provide surgeons with a clearer, uninterrupted field of vision.
Mendaera earns FDA clearance for Focalist handheld robotic system
With the clearance, Mendaera is starting a limited launch of Focalist with select medical institutions this year.
Intuitive Surgical obtains CE mark for da Vinci 5 robot
da Vinci 5, Intuitive’s latest-generation robot, won FDA clearance last year, as the company continues adding features.
Levita Magnetics MARS surgical robot receives expanded FDA clearance
Levita Magnetics has received clearance for the MARS, or magnetic-assisted robot surgery system, for bariatric and hiatal hernia repair.
Stereotaxis submits catheter pair for FDA clearance
In addition to the FDA 510(k) submission, Stereotaxis expects to submit the catheter for CE mark clearance in Europe this month.
Microbot Medical submits LIBERTY surgical robot to FDA for approval
Microbot Medical said LIBERTY eliminates the need for large and expensive equipment and streamlines customers’ access to robotics.
EndoQuest Robotics submits IDE application for pivotal colorectal clinical study
EndoQuest Robotics says its Flexible Robotic Surgical System will enable minimally invasive surgery through a variety of natural orifices.
Johnson & Johnson wins FDA exemption for Ottava surgical robot
The regulatory nod for Ottava allows Johnson & Johnson MedTech to begin a clinical trial for the surgical robot at U.S. sites.
Corin gets FDA approval of Unity Knee insert for robotic knee replacement
Corin continues to expand its Unity Knee MC portfolio with its latest insert, compatible with its surgical robot.
FDA clears Zimmer Biomet Persona Knee System with Think Surgical robot
The FDA cleared THINK Surgical’s miniature surgical robot for use with Zimmer Biomet’s Persona Knee System.
Obvius Robotics Certa access system earns FDA breakthrough nod
Obvius Robotics aims to improve the accuracy, safety, and consistency of central venous catheterization with its Certa system.
Wandercraft exoskeleton used in Olympic torch relay
Kevin Piette works for Wandercraft, the company that built what it calls a Personal Exoskeleton that could help disabled people walk.
Endiatx plans pivotal trial through Mayo Clinic; watch its live TED Talk demo
Endiatx plans to publish data from in-human trials, saying they are “progressing well, and physicians appreciate the technology.”
Moon Surgical receives FDA clearance for Maestro Robotic Surgery System
Moon Surgical plans to deploy its Maestro System in the U.S. and Europe in a limited market release ahead of a broader launch in 2025.
Intuitive seeks FDA clearance for next-gen da Vinci 5 surgical robot
Intuitive said it has also initiated conversations about da Vinci 5 with regulators in Japan and South Korea
Microbot Medical is a step closer to an FDA IDE submission
Microbot Medical has completed a pivotal pre-clinical study of its Liberty endovascular robotic surgical system.
Quantum Surgical makes its first surgical robot sale in U.S.
Quantum Surgical’s Epione surgical robot was financed by K2 Capital Group for the Miami Cardiac & Vascular Institute.
SRI International designs XRGo to protect pharmaceutical workers through teleoperation
SRI International says its XRGo teleoperation capability could help ensure pharmaceutical quality and open up jobs to a wider range of candidates.