TechMah Medical & LimaCorporate Receive First 510k Approval for Smart SPACE Digital Technology
UDINE, Italy, Dec. 9, 2019 /PRNewswire/ — LimaCorporate is pleased to announce the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Smart SPACE is an innovative digital platform developed by TechMah Medical thanks to collaboration with LimaCorporate, who entered into a milestone-based acquisition agreement last year. TechMah Medical was founded by Dr. Mohamed Mahfouz, Professor of Biomedical Engineering at the University of Tennessee, in 2014.
The platform provides surgeons with intuitive, surgeon-driven software solutions for 3D pre-operative planning and 3D Positioners for intra-operative positioning. In a second step, the platform will integrate intra-operative surgical guidance systems that aim to simplify shoulder arthroplasty and create precision in personalized patient care.
This approval is a key milestone for Smart SPACE and provides LimaCorporate the possibility of combining best in class hardware, pioneering 3D Printing technologies and now proprietary and patent-protected software. The full roll-out of Smart SPACE will apply to Shoulder, Hip and Knee arthroplasty.
“With this first important step now achieved, we are on our way to making a significant contribution to transforming how Orthopedic surgery is approached today with digital technologies combined with hardware, all in the hands of the surgeon,” commented Luigi Ferrari CEO of LimaCorporate.
LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.
About TechMah Medical
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: limacorporate.com
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SOURCE Limacorporate S.p.A.