NovaLign Orthopedics Inc. can now market its first product, a bone fixation system, after it received clearance from the Food and Drug Administration.
Regulatory
IlluminOss™ Photodynamic Bone Stabilization System Receives CE Mark
IlluminOss Medical Inc., a medical device company developing the innovative IlluminOss™ Photodynamic Bone Stabilization System for orthopedic surgery, today announced that it had been granted a CE Mark.
Covidien Receives FDA Clearance for the Nellcor™ OxiMax™ N-600x™ Pulse Oximeter with OxiMax SPD™ Alert
Covidien, a leading global provider of healthcare products, today announced that the United States Food and Drug Administration has issued a 510(k)marketing clearance for the Nellcor™ OxiMax™ N-600x™ pulse oximeter with OxiMax SPD™ alert for adults.
XTENT Receives CE Mark Approval for CUSTOM NX ® Drug-Eluting Stent System
XTENT, Inc. today announced that it has received CE Mark approval for its CUSTOM NX drug-eluting stent (DES) System.
KCI Announces It Will Appeal German Patent Ruling
Kinetic Concepts, Inc. announced that the German Federal Patent Court has ruled that a German patent licensed to KCI from Wake Forest related to KCI’s V.A.C.® technology is invalid.
Edwards Lifesciences Prevails in German Patent Infringement Case Initiated by Cook
Edwards Lifesciences Corporation, the world leader in the science of heart valves, announced that the District Court of Düsseldorf, Germany, today determined that it does not infringe on Cook Inc.’s German transcatheter valve patent.
Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer’s rivaroxaban
An Advisory Committee to the U.S. Food and Drug Administration met today to discuss the new drug application for Bayer’s rivaroxaban, a novel, oral anticoagulant taken as one tablet, once-daily for the prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Invatec Receives CE-Mark For Second Drug-Eluting Balloon Platform
Invatec, a comprehensive innovator of interventional products, announced CE-certification of a new coronary balloon, the IN.PACT™ Falcon paclitaxel-eluting PTCA balloon catheter.
Arobella Medical Announces European CE Mark Approval of Qoustic Wound Therapy System™
Arobella Medical, LLC, announced European CE Mark approval of its Qoustic Wound Therapy System™ medical device for ultrasound aided wound care.
St. Jude Medical Announces FDA Approval Of New Features In Remote Patient Care For Implantable Cardiac Devices
St. Jude Medical, Inc. announced U.S. Food and Drug Administration approval of the newest version of the Merlin.net™ Patient Care Network, a secure, Internet-based remote care system for patients with implanted medical devices.
Flexible Stenting Solutions, Inc. Announces IDE Submission for FlexStent® Femoropopliteal Self Expanding Stent System
Flexible Stenting Solutions Inc. has submitted an Investigational Device Exemption application to the FDA for its FlexStent® Femoropopliteal SE Stent System for the treatment of peripheral artery disease in the superficial femoral and popliteal arteries.
OrbusNeich Files Patent Infringement Lawsuit Against Boston Scientific
OrbusNeich Medical, Inc., a designer, developer, manufacturer and marketer of innovative medical devices for the treatment of vascular diseases, today announced that it has filed a lawsuit against Boston Scientific Corporation.
St. Jude Medical Announces European CE Mark Approval of Neurostimulation System for Chronic Angina
St. Jude Medical, Inc. today announced European CE Mark approval of its Genesis® neurostimulation system for managing a form of chest pain known as chronic angina pectoris, or chronic angina.
All-Inclusive Solution For Rigid Posterior Fixation Of The Cervico-Thoracic Regions Of The Spine
K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, announced the introduction of an all-inclusive solution for rigid posterior fixation of the cervico-thoracic regions of the spine, the CASPIAN™ Spinal System.
FDA Approves SyntheMed’s REPEL-CV® Adhesion Barrier for Use in Pediatric Cardiac Surgery
SyntheMed, Inc., a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that the U.S. Food and Drug Administration has approved the Pre-market Approval application for REPEL-CV® Adhesion Barrier for use in pediatric cardiac surgery patients.
SBi’s S.T.A.R. Total Ankle Replacement System Receives FDA Approvable Letter
Small Bone Innovations, Inc. (SBi) announced today that an ‘Approvable Letter’ has been received from the U.S. Food and Drug Administration (FDA) for the Scandinavian Total Ankle Replacement system (S.T.A.R. Ankle).