Spinal Stabilization News
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Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who receive either LimiFlex or ...
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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 Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in the investigational arm of its U.S. IDE trial studying the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal ...
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Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in its U.S. IDE trial studying the use of LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) ...
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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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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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Empirical Spine Presents Data from Study of the LimiFlex Tension Band at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021
Empirical Spine, Inc., a Silicon-Valley based medical technology company, announced today that data from the IDE study of the company’s LimiFlex Tension Band for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis, was presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021. The SMISS Annual Forum took place from October 28 ...
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Empirical Spine Closes $10 Million Series B Financing
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced the closing of a Series B financing of $10 million. SHD (Scientific Health Development) led the round, with additional investment from GP&G (Green Park & Golf) and other syndicate members. The funds will be used to advance the product on its path to market, including completing the ongoing pivotal trial ...
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Sharp HealthCare launches new Implant Stability Assessment Service
Halifax Biomedical Inc. (HBI), a Nova Scotia-based company specializing in precision assessment of spine and joint-replacement micro-instability, is pleased to announce that Sharp HealthCare (Sharp) will be implementing HBI’s innovative Implant Stability Assessment Kit at their Coronado, California facility. Sharp HealthCare is a not-for-profit integrated regional health care delivery ...
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Centers for Medicare and Medicaid Services Issues Updated Payment Guidelines for Halifax Biomedical Services.
The Centers for Medicare & Medicaid Services (CMS) in the United States have issued an update to payment policies and payment rates for services furnished to Medicare beneficiaries in hospital outpatient departments and Ambulatory Surgical Centers (ASCs) beginning January 1, 2015. The following procedures codes that relate to HBI’s products and services were addressed in this payment ...
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