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.
FDA recalls Asensus surgical robot due to unintended movement
The issue involves a laparoscope instrument actuator that rotates continuously in one direction after the surgeon removed the engagement of teleoperation on the system.
Johnson & Johnson plans to submit Ottava surgical robot for FDA IDE next year
Johnson & Johnson first shared details on the Ottava surgical robotic platform nearly three years ago, and now its sharing its plans to seek FDA approval.
Asensus Surgical targets FDA clearance for Luna surgical robot in 2025
Asensus Surgical announced its second-quarter financial results and shared an update on its Luna surgical robot platform.
Asensus Surgical wins CE mark for expanded machine learning
New features from Asensus Surgical include 3D measurement, digital tagging and image enhancement.
FDA clearance expands indications for Xact Robotics’ ablation system
The Xact Ace system combines image-based procedure planning and real-time monitoring with hands-free precise robotic insertion and non-linear steering.
First robot-assisted system for transvaginal hysterectomy approved by FDA
The U.S. Food and Drug Administration (FDA) authorized marketing for Memic Innovative Surgery’s Hominis system for transvaginal hysterectomy. According to the FDA, Hominis is the first FDA-approved robotically-assisted surgical device for performing transvaginal hysterectomy, with indication for performing benign hysterectomy with salpingo-oophorectomy. Using minimally invasive surgical instruments inserted through the vagina and a video camera…
FDA approves Think Surgical’s robotic knee surgery system
The newly-cleared version of the system features includes an enhanced pre-surgical planning user interface, quick-change tooling, improved surgeon accessories, and advanced bone model generation.
Ottava surgical assistant robot finally unveiled by Johnson & Johnson
After delays, Johnson & Johnson has announced its Ottava robot-assisted surgical platform, which it claimed will be more flexible than other systems currently on the market.