LimaCorporate and TechMah Medical Receive Regulatory Approvals For Smart SPACE Digital Platform
KNOXVILLE, Tenn., Feb. 12, 2021 /PRNewswire/ -- 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 Guidancein 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."
About TechMah Medical
About the Founders
Dr. Mahfouz is the Principal Founder and President/CEO of TechMah Medical LLC. His primary focus is on moving research concepts into medical applications in the fields of medical imaging, orthopedic surgery, real-time positioning, electronic hardware, and many others. Dr. Mahfouz has over 30 years of experience in industry and academia.
Dr. Michael Johnson
Dr. Emam ElHak Abdel Fatah
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SOURCE TechMah Medical LLC