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.

LimaCorporate, TechMah Medical Receive Regulatory Approvals For Smart SPACE Digital Platform

LimaCorporate, TechMah Medical Receive Regulatory Approvals For Smart SPACE Digital Platform

LimaCorporate and TechMah Medical LLC announced today important strides in the development of their digital platform designed to assist surgeons in delivering improved outcomes with an accessible and sustainable economic model, following LimaCorporate’s milestone-based acquisition of TechMah Medical. TechMah Medical was founded by Dr. Mohamed Mahfouz, Professor of Biomedical Engineering at the University of Tennessee, Dr. Michael Johnson, and Dr. Emam ElHak Abdel Fatah in 2014.

On December 28, 2020 TechMah Medical LLC received 510-K clearance from the FDA for its proprietary Smart SPACE Humeral 3D Positioner for use in Total Shoulder Arthroplasty and on February 3, 2021 it received 510-K clearance for its Smart SPACE Cubit Guidance also for Total Shoulder Arthroplasty. In addition, on January 19, 2021, the CE Mark for the Apple Macintosh OS version of the Smart SPACE 3D Virtual Planner was obtained by LimaCorporate.

Smart SPACE is LimaCorporate’s digital platform and features novel orthopedic technology and a rich pipeline of landscape-changing applications. Smart SPACE is a new environment designed to further enable the surgeon and enhance the predictability of surgical outcomes providing peace-of-mind to the physician. The Humeral 3D Positioner and Shoulder Cubit Guidance are important and innovative cornerstones of the Smart SPACE ecosystem.

This pioneering digital platform is intended to allow surgeons to develop a complete pre-operative plan, utilizing the Smart SPACE 3D Virtual Planner and execute the plan precisely using a combination of patient-customized 3D Positioners and the Cubit Guidance System with its proprietary sensor technology. Surgeons using the system receive real time feedback regarding instrument and implant positioning, all while maintaining their desired OR and patient set up.

Smart SPACE Shoulder Planner is currently in a controlled release within the United States and Europe. LimaCorporate is planning to commence the commercial release of the Shoulder Planner later in Q1 2021 and will initiate surgeries with the Humeral 3D Positioner and Shoulder Cubit Guidance in Q2 2021. Smart SPACE was developed in collaboration with TechMah Medical LLC.

Luigi Ferrari, LimaCorporate CEO, stated: “Following with our tradition of innovation, we are planning a significant number of new product releases for 2021. We are thrilled that many of our new product releases in 2021 involve Smart SPACE, our contribution to transform orthopedics in 2021. I am very excited to see tangible progress on the release of Smart SPACE.”



Submit a Comment

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