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Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Olympus Supports Safety Actions Regarding Surgical Smoke

Olympus has announced its support of The Joint Commission’s recommended safety actions for managing the hazards of exposure to surgical smoke for health care staff in operating rooms.

Exofin Fusion Redesign Receives FDA Approval

Chemence Medical, a leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration’s (FDA) 510(k) approval of the company’s redesigned exofin fusion skin closure system.

Fusion Robotics Receives 510(k) Clearance for Spinal Navigation and Robotics System

Fusion RoboticsFusion Robotics LLC, a spinal robotics and navigation company has received 510(k) clearance to market its 3D imaging compatible navigation and robotic targeting system for spine surgery in the U.S. market.

The Fusion Robotics System addresses the key limitations of current spinal navigation and robotics systems by offering greater procedural efficiency with significantly less expense.

“We appreciate the partnership developed with FDA to rigorously validate safety and accuracy. Next, we look forward to partnering with clinicians and hospitals to increase efficiency, reduce cost and broadly expand the application of robotics to treat patients,” said Brad Clayton, CEO of Fusion Robotics.

Fusion Robotics Chief Medical Officer Kevin Foley, MD, said, “Since the introduction of robotics in spine surgery, the questions of economics and efficiency have hindered the widespread adoption of this technology. With this clearance, and the rapid development of our fluoroscopy-integrated system, we’re working quickly towards making robotics available to many more surgeons, in a form better suited to their practices.”

The company plans to commercialize broadly across the U.S. in 2021.

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