LimaCorporate Receives Regulatory Approvals For Smart Space Digital Platform
SAN DANIELE DEL FRIULI, Italy, Feb. 11, 2021 /PRNewswire/ -- LimaCorporate makes important strides in the development of its digital platform designed to assist surgeons in delivering improved outcomes with an accessible and sustainable economic model, following the milestone-based acquisition of TechMah Medical LLC. TechMah Medical LLC was founded by Dr. Mohamed Mahfouz, Professor of Biomedical Engineering at the University of Tennessee, 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 03, 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 Mac 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 will 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.
Luigi Ferrari, LimaCorporate CEO, stated: "Following with our tradition of innovation, we are planning a significant number of new product releases in 2021. We are thrilled that many of these will involve Smart SPACE, our contribution to transform orthopedics."
About LimaCorporate
LimaCorporate is a global orthopedic company, focused on digital innovation and tailored hardware, which advances patient centered care. Its pioneering technological solutions are developed to empower surgeons, and to improve patient outcomes from joint replacement surgery. Its primary focus is on providing reconstructive and custom-made orthopedic solutions to surgeons, enabling them to improve the quality of life of patients by restoring the joy of movement.
Headquartered in Italy, the company operates directly in over 20 countries around the world. LimaCorporate offers products ranging from large joint revision and primary implants, to complete extremities solutions, including fixation.
About TechMah Medical LLC
TechMah Medical LLC is a technology company focused on delivering orthopedic solutions. We build innovative applications designed to improve patient and clinician experience throughout the joint replacement process. Based in Knoxville, Tennessee, our team of scientists and engineers are driven to improve quality and efficiency through customization.
For additional information on the Company, please visit www.limacorporate.com.
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Contact:
Limacorporate spa
Via Nazionale, 52
33038 Villanova di San Daniele
Udine, Italy
+39 0432 945511
[email protected]
SOURCE Limacorporate S.p.A.
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