Musculoskeletal Clinical Regulatory Advisers



			June 24th, 2010




	Clinical, Regulatory, IP, Compliance & Reimbursement June 24, 2010 IOM Committee Questions Adequacy Of Compliance Tools In 510(k) Program June 22, 2010 CDRH’s Shuren: FDA’s 510(k) findings due soon June 22, 2010 Texas judge gives, takes away from Smith & Nephew in Arthrex patent suit FDA plans public recalls database Early Clinical Results Show High Degree of Accuracy and Ease-of-Use KneeAlign Surgical Navigation System June 21, 2010 No News June 18, 2010 Studies conflict over therapy with platelet-rich fluid June 17, 2010 No News June 16, 2010 No News June 15, 2010 Gephardt-Led Group Steps Up Medical Innovation Lobbying Effort June 14, 2010 No News June 11, 2010 Appeals court gives TriMed a win in patent dispute New Hips Gone Awry Expose U.S. Kickbacks in Doctors’ Conflicts June 10, 2010 TiGenix: Positive 5-year ChondroCelect follow-up results to be presented at ESSKA June 9, 2010 Intramedullary nails outperformed sliding hip screws in transtrochanteric fracture investigation June 8, 2010 May 2010 510(k) Clearances Favorable Results of Level-1 Clinical Study on Wright’s GRAFTJACKET(R) Matrix for Augmenting Rotator Cuff Repair Presented at Recent Arthroscopy Association of North America Meeting June 7, 2010 MiMedx Receives FDA Clearance to Market Additional HydroFix™ Vaso Shield Device Configurations June 4, 2010 Biomet Announces Enrollment of First Subject into Its Investigational Device Exemption Clinical Trial for Critical Limb Ischemia Utilizing Autologous Concentrated Bone Marrow Aspirate June 3, 2010 April 2010 PMA Approvals June 2. 2010 Amedica® Receives Patent for Hip Implant Using Monoblock Ceramic Technology Wright Medical resolves lawsuit with Stryker subsidiary June 1, 2010 RepRegen™ Reports Data from an In Vivo Study of StronBone™ Bone Graft Substitute — The First Product from the Company’s Platform to Repair and Regenerate Hard Tissue, Such as Bone Two-Year Follow up Data of NuBac® IDE Feasibility Study Was Presented at SAS Meeting Idaho Orthopedists Charged With Engaging in Group Boycotts and Denying Medical Care to Injured Workers May 28, 2010 Salient Surgical Technologies Expands Presence in Japanese Market With AQUAMANTYS(R) System May 27, 2010 No News May 26, 2010 Medical Device Alert: DePuy ASR acetabular cups used in hip resurfacing arthroplasty and total hip replacement May 25, 2010 Applied Spine Technologies Awarded Two New Patents, Expanding Stabilimax® IP Portfolio KFx Medical Corporation Announced Today It Has Received FDA 510k Clearance for Product(s) Used in a Wide Variety of Arthroscopic Tenodesis Knee Procedures Such as: ACL, PCL, and Patellofemoral Ligament (MPFL) Reconstruction May 24, 2010 X-spine Announces New FDA Clearance of Spinal Implant System MiDAS I CLINICAL STUDY RESULTS DEMONSTRATE SIGNIFICANT IMPROVEMENT IN PATIENTS TREATED WITH mild® Study Shows RF Kyphoplasty Procedure with StabiliT® Vertebral Augmentation System Led to 91% Less Cement Leakage (0 symptomatic) Compared to Vertebroplasty in Osteoporotic Fractures 9 US Hospitals Settle Claims Of Medicare Fraud For $9.4 Million May 21, 2010 FDA plan would publicize drug safety problems, manufacturing violations of companies May 20, 2010 No News May 19, 2010 Stryker Announces Resolution of Two FDA Warning Letters Mesoblast Announces United States FDA Clears Phase 2 Trial for Cervical Spinal Fusion May 18, 2010 No News May 17, 2010 Whistleblower Lawyers Comment on Hospital Settlements of Kyphoplasty Case May 14, 2010 ISTO Technologies, Inc. Announces Release of Peer-Reviewed Scientific Publication Related to Its Juvenile Cartilage Technology May 13, 2010 Anika Therapeutics Communicates Status of Compliance Issues with the FDA May 12, 2010 No News May 11, 2010 April 2010 510(k) Clearances May 10, 2010 March 2010 PMA Approvals May 7, 2010 Swept Up in Major Medical Device Case, Physician Pays $650,000 to Settle Kickback Charges May 6, 2010 MMI-USA Announces New Patent Applications, Stricter Protections of Device Designs Kickbacks case against Stryker dismissed May 5, 2010 Bone Solutions Inc. (BSI) Prepares Four Additional FDA Filings for OsteoCrete™, Expanding Options for Potential Strategic Partnerships ORTHO Receives FDA Clearance on Titanium IM Nail System Wright Medical Q1 tops view; says may settle DOJ probe May 4, 2010 New Data Reinforces the Proven Safety and Effectiveness of the BIRMINGHAM HIP Resurfacing System May 3, 2010 Mazor device successfully treats children’s spinal scoliosis April 30, 2010 MESOBLAST COMPLETES ENROLMENT FOR FIRST SPINAL FUSION TRIAL April 29, 2010 DFine Inc Issued Method Patent for StabiliT® Vertebral Augmentation System April 28, 2010 Applied Spine Technologies Awarded New Patent Nation’s Leading Patient Advocacy Group Unveils New Patient Data Analysis Report; Finds Increase in Case Complexity, Medicare Denials, Underinsure Long-term study shows favorable results using uncemented femoral stems in younger patients April 27, 2010 F.D.A. Steps Up Oversight of Infusion Pumps April 26, 2010 VertiFlex®, Inc. Announces 100th Patient Enrolled in Superion™ IDE Trial FDA Changes Process for Medical Device Advisory Committees April 23, 2010 Facet Solutions Announces 2 Year Data from US Pilot Study FDA Launches Initiative to Reduce Infusion Pump Risks April 22, 2010 Flexuspine receives FDA conditional approval to begin a feasibility study of its FSU (Functional Spinal Unit) Total Spine Arthroplasty system in the United States. IDE Trial Data for Applied Spine Technologies’ Stabilimax® System to be Presented at Spine Arthroplasty Society Meeting in New Orleans Smith & Nephew Receives FDA 510k Clearance for a 30-year Knee April 21, 2010 Orthofix International Comments on Competitor’s Statements on Investor Call April 20, 2010 LDR is the First to Announce Completion of Two-year Follow-Up on a Two-Level Cervical Artificial Disc IDE Study Patent Received for the TruFUSE(R) Minimally Invasive Facet Fusion Procedure Millstone Medical Outsourcing Registers as Human Tissue Bank with FDA, Completes Registration, Licensing Requirements for Six States April 19, 2010 3M files copyright suit against Andover Healthcare April 16. 2010 Clinical study demonstrates EOS reduces patient’s radiation exposure by up to 89% compared to standard CR x-rays while substantially improving image quality April 15, 2010 Exactech Approved to Begin Marketing Novation® Hip System in High Demand Asian Market « Previous Entries Next Entries »





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