Bone Solutions Inc. announced today that it has received FDA 510(k) clearance for the first device in its technology pipeline—a proprietary bone void filler, OsteoCrete™.
FDA Approval
Innovia LLC announced that it has received FDA 510(k) clearance to market the InnoPort™
Innovia LLC announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the InnoPort™ to facilitate single port access laparoscopy.
FDA Approves SBi’s S.T.A.R. Total Ankle Replacement System
Small Bone Innovations, Inc., a leading provider of innovation, products, technology and education for the small bone & joint segment of the orthopedics industry, announced today that the FDA has approved SBi’s Scandinavian Total Ankle Replacement (S.T.A.R.®) system to treat U.S. patients.
FDA Clears Boston Scientific’s SpyScope® Access and Delivery Catheter
Boston Scientific Corporation today announced that it has received FDA 510(k) clearance to market its SpyScope® Access and Delivery Catheter for diagnostic and therapeutic applications in the pancreatico-biliary system.
FDA Approves Boston Scientific’s Next-Generation TAXUS® Liberte® Atom™ Stent System
Boston Scientific Corporation today announced it has received approval from the U.S. Food and Drug Administration to market its TAXUS® Liberte® Atom™ Paclitaxel-Eluting Coronary Stent System.
FDA to Review Its Approval of Knee Device
The Food and Drug Administration said it will re-examine its decision to approve a knee-surgery device last December over the objections of several scientists and managers at the agency, according to a letter from the FDA that the Senate Finance Committee reviewed Monday.
St. Jude Medical Announces FDA Approval of Current Plus ICD and Promote Plus CRT-D Devices
St. Jude Medical, Inc. today announced U.S. Food and Drug Administration approval of the Promote® Plus cardiac resynchronization therapy defibrillator and Current® Plus implantable cardioverter defibrillators.
Edwards Lifesciences Receives FDA Approval for New Heart Valve
Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced that it has received approval from the U.S. Food and Drug Administration for the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, designed for easier implantation in the heart.
Gore Receives FDA Clearance For GORE BIO-A Fistula Plug
W. L. Gore & Associates announced that the US Food and Drug Administration has given the company 510(k) clearance to market the GORE BIO-A Fistula Plug, the next generation of anal fistula repair.
St. Jude Medical Announces FDA Clearance and Launch of the Attune Annuloplasty Ring for Heart Valve Repair
St. Jude Medical, Inc. today announced the U.S. launch of its Attune™ Flexible Adjustable Annuloplasty Ring for the repair of diseased heart valves.
FDA Approves New Medtronic Left Heart Lead for Cardiac Resynchronization Therapy Devices
Medtronic, Inc. today announced U.S. Food and Drug Administration approval and availability of the Attain Ability® left-heart lead (Model 4196) for use with cardiac resynchronization therapy devices for heart failure patients.
CoreSpine Technologies™ Receives Clearance To Market Surgical Disc Preparation Device
CoreSpine Technologies announced today it has received 510(k) clearance to market from the U.S. Food and Drug Administration for its XTEND-ST™ Nucleus Removal System.
X-spine Announces New FDA Clearance of Spinal Implant System
X-spine Systems, an emerging manufacturer of implants and instruments for spinal surgery, announces FDA clearance of its new Calix spinal implant system.
ISTO Technologies, Inc. Announces FDA Approval to Initiate a Clinical Trial for a Novel Treatment for Disc Nucleus Regeneration
STO Technologies, Inc. announced today that it has received notification from the U.S. Food and Drug Administration allowing the company to proceed with a Phase I clinical study for NuQu™, a cell-based injectable formulation of juvenile chondrocytes designed to regenerate cartilage, restore disc function and relieve discogenic back pain.
Core Essence Receives FDA Approval For SECURUS™, An Innovative Knotless Suture Anchor System
Core Essence Orthopaedics, Inc. announced that it has received 510(k) regulatory approval from the Food and Drug Administration for SECURUS™, a novel knotless suture anchor system used in minimally invasive, arthroscopic surgery.
NMT Medical Receives PMA Approval for STARFlex as a Ventricular Septal Defect Repair Implant
NMT Medical, Inc. today announced that it received Pre-Market Approval from the U.S. Food and Drug Administration enabling commercial sale of the Company’s STARFlex® cardiac septal repair implant in the United States for patients with ventricular septal defects.