Interventional Spine, Inc. has announced the FDA clearance of its Opticage™ Expandable Intervertebral Body Fusion Device for treatment of degenerative disc disease.
FDA Approval
Curos® Disinfecting Port Protector Gains Extended Approval From FDA
Ivera Medical Corporation can now claim improved performance including a reduction in disinfection time and an extension of the product’s effective duration of use for its Curos Disinfecting Port Protector.
Gore® TAG® First Device FDA Cleared For Endovascular Repair Of Traumatic Aortic Transections
Two years after receiving its “equivalent” CE mark approval, W L Gore has now announced an extension of the indications for use of its Conformable Gore TAG endoprosthesis to include traumatic aortic transections.
Biomet Receives FDA Clearance For Two New Shoulder/Elbow Products
Biomet, Inc., has announced FDA clearance of two new products; the E1® humeral bearing for use with the Comprehensive® Reverse Shoulder System, and the Comprehensive® Segmental Revision System.
China Looks To USA As USA Looks To China
Many large American companies consider the Far East to represent the best chance for growth, while paradoxically Chinese manufacturers are looking at USA as an opportunity to increase their own revenues.
FDA Clearance For da Vinci Vessel Sealer: CE Mark Next?
Intuitive Surgical, Inc. has announced that it received FDA clearance to market its EndoWrist® One™ Vessel Sealer instrument for use with the da Vinci® Si™ Surgical System.
Vertebral Motion Analyser System Receives FDA Clearance
Ortho Kinematics Inc has announced FDA clearance for its KineGraph VMA system. The company aims to replace the flexion/extension x-ray method of detecting spinal dysfunction
FDA Nod For S&N’s PICO Portable Negative Pressure Wound System
Smith & Nephew plc has followed last year’s launch of PICO in Europe, Canada, and Australia by announcing that its pocket-sized PICO single use Negative Pressure Wound Therapy (NPWT) system has now received FDA clearance.
da Vinci Single Site Lap Chole System Gains FDA Approval
Intuitive Surgical, Inc. the global leader in minimally invasive robotic-assisted surgery, has announced that it has received FDA clearance to market its Single-Site Instrumentation for laparoscopic cholecystectomy procedures.
FDA Approves DePuy’s AOX ™Antioxidant Polyethylene Bearing
DePuy Orthopaedics, Inc.has received FDA Premarket Approval to use its AOX ™ Antioxidant Polyethylene material with the company’s SIGMA ® Rotating Platform Knee System and LCS ® COMPLETE ® Mobile Bearing Knee System.
Two New Products From Boston Scientific
Boston Scientific launchea CHARGER™ PTA Balloon catheter in USA and Infinion 16, first and only 16-contact percutaneous lead for treatment of patients suffering chronic pain.
Covidien Gets FDA Approval 6 Years After CE Mark
Covidien has announced that the U.S. Food and Drug Administration (FDA) has expanded the cope of approval for its SpiderFX® embolic protection device to include the treatment of severely calcified lesions used in conjunction with plaque excision in arteries of the lower extremities.
Aptus HeliFX EndoStapling System Cleared By FDA
Aptus HeliFX Endograft Fixation Device follows May CE Mark with FDA approval.
Boston Scientific Receives FDA Approval for PROMUS Element™ Plus Platinum Chromium Stent System
Boston Scientific has announced that it has received U.S. Food and Drug Administration (FDA) approval for the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System.
AIM Float for Sphere Medical Brings Near Real-Time Accurate Blood Gas Analysis Closer
Sphere Medical, a UK based developer of blood monitoring and diagnostic products, has issued a press release in which it has announced its flotation and new product plans.
US Consumer Group Wants (Even) Stronger FDA
US Consumers Union is arguing that Congress should strengthen the Food and Drug Administration’s ability to regulate medical devices in order to improve quality, safety and effectiveness.