Musculoskeletal Clinical Regulatory Advisers



			September 3rd, 2010




	Clinical, Regulatory, IP, Compliance & Reimbursement No News September 2, 2010 Mazor wins FDA nod for combined surgical systems Ascension Orthopedics Receives FDA Approval for TITAN™ Modular Total Shoulder System The Bonati Spine Institute Supports Recent Study Reporting That Invasive Back Surgery is Overused A Randomized, Prospective Study of Total Hip Wound Closure With Resorbable Subcuticular Staples Arthroscopic Rotator Cuff Repair: Great Outcomes for Patients Over 70 September 1, 2010 Insurance status influences continuity of care for ambulatory patients with operative fractures Early results of arthroscopic lateral ankle ligament reconstruction promising August 31, 2010 Amedica® Receives Patent for Knee Prosthesis With Monoblock Silicon Nitride Ceramic Tibial Component August 30, 2010 TiGenix announces the grant of a US patent for ChondroMimetic Pre and Post-Operative Use of Caldolor® (Ibuprofen) Injection Significantly Reduces Pain and Opioid Use in Newly Published Study August 27, 2010 Medtronic frets over state control of device coverage decisions August 26, 2010 DePuy Orthopaedics Voluntarily Recalls ASR™ Hip System AG Coakley Announces $1.35 Million Settlement with Stryker Biotech August 25, 2010 Medyssey Spine Receives FDA 510(k) Clearance for Zenius(TM) Thoracolumbar Spinal System in Titanium Alloy (Ti6AL-4V ELI) August 24, 2010 Johnson & Johnson Gets FDA Warning On Marketing August 23, 2010 July 2010 PMA Approvals August 20, 2010 U.S. Inquiry of Drug Makers Is Widened August 19, 2010 Benvenue Medical Begins Enrollment in Landmark Study Versus Balloon Kyphoplasty August 18, 2010 Aesculap Implant Systems, Inc. Receives FDA 510(k) Clearance for the A-Fix™ (SIBD) Spinal System August 17, 2010 Biomet Receives FDA Warning Letter, Seeks Resolution with FDA U.S. Inquiry of Drug Makers Is Widened August 16, 2010 NuOrtho Surgical, Inc. today announces that the findings of two separate studies discussing early surgical intervention for the articular cartilage damage of osteoarthritis. August 13, 2010 No News August 12, 2010 Cytori Issued Celution® System Patent for Orthopedic & Spinal Disc Diseases BioMimetic Therapeutics Receives Orphan Drug Designation for rhPDGF-BB Treatment of Osteochondritis Dissecans August 11, 2010 No News August 10, 2010 Whistleblowers Return for a Second Bite at False Claims Case Against Rush University Medical Center August 9, 2010 Spinal-Device Makers Report Rising Pressure From Insurers FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product August 6, 2010 Orthospace obtains CE Mark for shoulder balloon implant August 5, 2010 No News August 4, 2010 Medtronic, Stryker, J&J Face New U.S. Rules for Medical Device Approvals FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making Mass. gift ban repeal dies on the vine August 3, 2010 CMS to Consider Evidence on Bone Growth Agent June 2010 PMA Approvals August 2, 2010 VertiFlex®, Inc. Announces 150th Patient Enrolled in Superion™ IDE Trial Zimmer Gets Grassley Request for Reports on Product Complaints July 30, 2010 No News July 29, 2010 Ortho Kinematics Launches Multi-Site Clinical Study Of KineGraph VMA™ July 28, 2010 Medtronic’s AMPLIFY™ rhBMP-2 Matrix Receives Positive Votes from FDA Advisory Panel on All Three Key Questions: Safety, Effectiveness and Benefit/Risk The Centers for Medicare and Medicaid Services (CMS) will meet on September 22, 2010 to consider the currently available evidence regarding the clinical benefits and harms of on-label and off -label use of BMPs July 27, 2010 No News July 26, 2010 FDA Approves Orthovita’s New Collagen Facility FDA probes Medtronic, spinal implant’s cancer risk July 23, 2010 Medtronic Spinal Fusion Device Faces U.S. FDA Review Stone Research Foundation Study Reveals Biologic Joint Repair May Delay or Prevent the Need for Artificial Knee Joint Replacement July 22, 2010 TriMas’ Richards Micro-Tool Announces Key Business Developments July 21, 2010 Trinity Orthopedics Receives Patent Allowance for Sagittally Stable Spinal Fixation System Applied Spine Technologies Receives Notice of Patent Allowance for Travel Limiting Functionality in Dynamic Stabilization Devices July 20, 2010 SANUWAVE Health Granted European Patent July 19, 2010 Twelve-Week MiDAS I Clinical Study Data Confirm Safety, Efficacy of Vertos Medical’s mild® Orthovita Announces Presentations of Cortoss Clinical Study Results at the 17th International Meeting of Advanced Spine Technologies July 16, 2010 No News July 15, 2010 Ellipse Technologies Completes Enrollment for the Initial Clinical Trial of the MAGEC Remote Control, Non-Invasive System for the Treatment of Scoliosis July 14, 2010 Osseon Receives Patent Allowance for Novel Spinal VCF Treatment Devices NuOrtho Surgical Receives FDA 510(k) Clearance July 13, 2010 Brookhaven Lab and BioSET, Inc., Patent Improved Growth Factor Technology; Second-Generation Technology Has Multiple Applications in Soft Tissue Repair July 12, 2010 XYLOS® VESSEL GUARD RECEIVES FDA 510(K) CLEARANCE FOR ANTERIOR VERTEBRAL SURGERY Anika Therapeutics Comments on Patent Litigation July 9, 2010 Histogenics launches clinical trial May 2010 PMA Approvals July 8, 2010 OXPEKK-IG Device Viking Gains Regulatory Approval in Korea July 7, 2010 June 2010 510(k) Clearances Data suggests orthodpedic firms should worry most about FDA changes BioMimetic Therapeutics, Inc. Releases Clinical Update Including Positive 52-Week Data from North American Pivotal Trial July 6, 2010 RepRegen™ receives CE marking approval for StronBone™, the first product from company’s platform to repair and regenerate hard tissue, such as bone FDA Brainstorms New Regulatory Models To Address Unmet Health Needs July 2, 2010 No News July 1, 2010 No News June 30, 2010 Cerapedics, Inc. Receives CE Mark for i-FACTOR™ Flex Bone Graft June 29. 2010 No News June 28, 2010 BioMimetic Therapeutics Receives Filing Letter from FDA for Augment™ Bone Graft PMA July 27, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting Notice Regarding to Medtronic’s Premarket Approval Application of AMPLIFY rhBMP-2 Matrix June 25, 2010 Legislation circulating in the Mass. House of Representatives would kill the 2008 gift ban governing industry relationships with physicians « Previous Entries





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