Zimmer Biomet's robotic surgical system ROSA One Brain application gains FDA clearance

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By: Katie Bell

Ref: Zimmer Biomet

Published: 02/11/2019

Zimmer Biomet's robotic surgical system ROSA One Brain application gains FDA clearance

Zimmer Biomet announced Monday that its next-generation robotic surgical navigation and positioning system, dubbed the ROSA One Brain application, received FDA clearance for use in neurosurgical procedures. The company noted that the platform, which builds upon the ROSA Brain application with enhanced performance and usability, was designed to be expandable into other specialties, with a spine application pending clearance.

According to Zimmer Biomet, a single robot that is able to perform both brain and spine surgery will "significantly advance" the company's position in the robotic surgical space. Specifically, Zimmer Biomet said that the ROSA One Brain application can be used to assist in minimally invasive neurosurgery procedures, such as biopsies and deep brain stimulation, and the "ROSA One Spine application is expected to bring these same robotic advantages to thoracolumbar spine surgery, assisting in the accurate and reproducible placement of surgical instruments in spinal procedures."

Zimmer Biomet gained the ROSA Brain application through its acquisition of surgical robot company Medtech in 2016. Meanwhile, last month, the FDA granted 510(k) clearance for the ROSA Knee system for robotically-assisted total knee replacement surgeries.

A number of traditional medical technology companies have been moving into the robotic surgery space, with Medtronic buying Mazor Robotics last year for $1.7-billion. More recently, sources suggested that Johnson & Johnson is looking to buy Auris Health in an effort to add surgical robotic technology to its portfolio, and is willing to pay a premium to the latter's $2-billion valuation from its latest round of funding.