NEW

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.

FDA Releases Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices

The FDA has released its report “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” in accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).

The executive summary of the report states: “We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices, including by third party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time. Although we do not believe that additional, formal regulatory action is warranted, based on the available information and findings, we intend to pursue the following actions:

  1. Promote the Adoption of Quality Management Principles;
  2. Clarify the Difference Between Servicing and Remanufacturing;
  3. Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices; and
  4. Foster Evidence Development to Assess the Quality, Safety and Effectiveness of Medical Device Servicing.”

Download a PDF of the report here.

Previous

Next

Submit a Comment

Your email address will not be published. Required fields are marked *

X