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 existing … Read more

NGMedical GmbH Receives FDA Clearance for Its BEE® HA Cervical Cage System Made From PEEK-OPTIMATM HA Enhanced

NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its anatomically shaped cervical interbody BEE® HA, made of the innovative PEEK-OPTIMA™ HA Enhanced from Invibio Biomaterial Solutions, a global leader in high-performance biomaterial solutions.  BEE® HA was developed to optimize fusion while maintaining elasticity that is similar … Read more

SIS Earns Sixth Consecutive #1 Client Rating in Ambulatory Surgical Center EHR User Satisfaction, Black Book Survey

Black Book Research announced the top comprehensive information technologies for electronic health record as collected from 1,382 ambulatory surgical centers, outpatient procedure surgeons and support IT users in Black Book’s annual poll of customer experience and satisfaction. In total, 40 ASC EHR vendors received crowd-sourced evaluations from the professionals’ polling conducted Q3 2020 to Q1 2021. … Read more

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 … Read more

NGMedical GmbH Receives FDA Clearance for Its AM Titanium Cervical Interbody BEE®

NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its purely additively manufactured titanium cervical BEE® cage. The BEE® cage is designed to challenge the limits of additive manufacturing. The purposefully designed honeycomb endplate design reduces the risk of subsidence while allowing fusion. The honeycomb … Read more