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

Fusion 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.

ECRI and oneSOURCE Plan Alerts Management Collaboration

ECRI and oneSOURCE Document Management Services have announced a joint collaboration focused on improving medical device safety and responsiveness of health care facilities.

TransEnterix Announces Name Change, Introduces a New Category of Surgery

The name change reflects the company’s broader vision of shaping the future of surgery by integrating computer vision and machine learning with surgical robotics.

Fujifilm Systems Integration Leads AIA-Accredited Course

During this one hour course, participants will learn about the importance of continuing to digitize systems and processes in the OR, the role digitization plays in ensuring that various technologies used during procedures are connected and accessible, and why it’s important to understand this evolution as architects and equipment planners.

Getinge informs about a medical device recall for the Maquet Axius Blower Mister

Getinge is informing about a global Medical Device Recall for the Axius Blower Mister. To date, there are no known adverse events associated with serious injury or death. Getinge has reported to relevant competent authorities according to applicable regulations and does not expect the cost for the recall to be material.

The Axius Blower Mister is a contract manufactured product for Getinge. The Axius Blower Mister provides controlled delivery of CO2 and saline during coronary artery bypass surgery. It allows the surgeon to operate a clear bloodless field and complete the anastomosis comfortably. Failure of the Blower mister to deliver a jet of CO2 and saline will impact the ability of the surgeon to complete the anastomosis in a dry bloodless field.

In total 7,880 units of Axius Blower Mister have been distributed globally between September 10, 2018, to January 8, 2019.

All concerned customers have received communication to return the product to Getinge for replacement or credit.

This information is released in order to inform users of mentioned Getinge products, according to applicable requirements by regulatory authorities.



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