spinal levels News
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Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis
Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its LimiFlex™ Paraspinous Tension Band. In doing so, the FDA has determined that LimiFlex™ holds the potential to offer significant advantages over ...
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Empirical Spine Submits PMA Module II for Limiflex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently submitted Premarket Approval (PMA) Module II in the US Food & Drug Administration (FDA) approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST). LimiFlex is ...
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Empirical Spine Advances LimiFlex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, achieved several clinical, reimbursement and regulatory milestones in the past 12 months that are moving its LimiFlex™ Dynamic Sagittal Tether™ (DST) closer to market in the US. The ...
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Saluda Medical Announces Highlights from 2021 North American Neuromodulation Society (NANS) Meeting
Saluda Medical Pty Limited (“Saluda Medical”), the market leader in the development of closed-loop spinal cord stimulation for the treatment of chronic pain, announced scientific highlights from the 2021 North American Neuromodulation Society (NANS 2021) Virtual Meeting, including real-world European commercial results and sub-analyses of 24-month and 12-month clinical data from the ...
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Wenzel Spine Announces Acquisition of Statera Spine
Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced that it has completed the acquisition of Statera Spine, a pre-operative diagnostics and quantitative data software solution that improves treatment decisions for spine patients. Statera Spine is a software enabled spine imaging analytics ...
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Dr. Frank Phillips is First in the World to Use Augmented Reality Surgical Guidance in Minimally Invasive Spine Surgery
CHICAGO--(BUSINESS WIRE)--Midwest Orthopaedics at Rush announced today that Dr. Frank Phillips, Professor and Director of the Division of Spine Surgery and the Section of Minimally Invasive Spine Surgery at Rush University Medical Center, completed the first augmented reality (AR) minimally invasive spine surgery. The Augmedics xvision™ Spine System surgical guidance system allows a surgeon ...
By Augmedics
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FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an important milestone in the commercial approval process for its ...
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