Interventional Spine, Inc. has announced the FDA clearance of its Opticage™ Expandable Intervertebral Body Fusion Device for treatment of degenerative disc disease.
Approval/Clearance
CE Mark For “Bi-Directional Retrieval” Inferior Vena Cava Filter
Crux Biomedical has announced it has received CE mark approval for its revolutionary inferior vena cava filter with bi-directional retrieval.
CE Mark For Articular Cartilage Diagnostic Assessment Tool
A new concept in non-destructive evaluation of articular cartilage has been CE marked by Biomomentum Inc.
FDA Allows CE Marked Glue In On “Investigational Device” Basis
Abstract Yet again the CE vs FDA debate is brought into sharp relief with the news that Cohera Medical has … continue reading “FDA Allows CE Marked Glue In On “Investigational Device” Basis”
CE Mark For WOUNDCHEK™Protease Status, First Point-of-care Diagnostic Test for Chronic Wounds
Systagenix Wound Management has announced that it has gained CE mark status for its WOUNDCHEK™ Protease Status diagnostic tool to aid wound assessment.
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.
CE Mark And Launch For Medtronic’s Endurant® II AAA Stent Graft System
Medtronic’s Endurant® II Stent Graft to repair Abdominal Aortic Aneurysms without open surgery.
Planmed’s Newly CE Marked Extremity CT Scanner Delivers Fast, Accurate, Low Dose 3D Imaging
Planmed’s Verity, a new, mobile extremity scanner for orthopedic imaging of the extremities has gained CE mark approval, bringing a new level of accuracy, speed, low dosage and adaptability to CT scanning.
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.
Smallest, Lightest, Quietest, Durable Insulin Pump Gains CE Mark
D.Medical has achieved CE mark status for its Spring™ Zone Insulin Delivery System featuring technology which is claimed to offer superior blockage and detachment detection in a device which is small, light, quiet and durable.
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
CE Mark For App To Improve Burns Assessment
Mobihealth News has reported on what may be the first medical app to gain CE Mark approval in the UK.
CE Mark For MindFrame’s New CAPTURE™ LP Ischemic Stroke Device
First and only 4-mm thrombectomy devices that can be deployed through catheters as small as 10/14 offer improved navigation and aspiration.