Premia Spine secured FDA approval for a pivotal IDE study of TOPS™, a posterior arthroplasty device for the treatment of spondylolisthesis and spinal stenosis. The study seeks to establish the superiority of TOPS vs. traditional lumbar spinal fusion.
TRICARE, a managed healthcare program for active duty and retired members of the U.S. military, established a written coverage policy for minimally invasive SI joint fusion such as is provided with SI-BONE’s iFuse™ implant.
Histogenics successfully completed consultations with Japan’s PMDA regarding the regulatory path for NeoCart® autologous cell therapy for the treatment of knee cartilage defects.
Results from a 124-patient study indicate that Inspired Spine’s OLLIF procedure was completed at ~2x the speed of an open TLIF, and reduced blood loss by >80% vs. TLIF.
Stryker Howmedica Osteonics/Stryker Orthopaedics informed courts that 95% of additional registered eligible patients have enrolled in its Settlement Program relative to revisions of the Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem.
CurveBeam received FDA 510(k) clearance for InReach, a Cone Beam CT imaging system designed for the hand, wrist/elbow and lower extremities in non-weight bearing positions.
TheraCell was issued U.S. Patent No. 9,636,436, "Compositions of and Methods for Cancellous Bone Matrix," addressing its ECS™ enhanced cancellous demineralized bone technology.