St. Jude Medical, Inc. today announced the U.S. launch of its Attune™ Flexible Adjustable Annuloplasty Ring for the repair of diseased heart valves.
Regulatory
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.
Amedica Receives CE Mark For Valeo™ Ceramic Spinal Implant System Incorporating CSC Technology
Amedica Corporation announced that it has received a CE mark for initial rollout of their spinal intervertebral spacers using novel CSC (cancellous-structured ceramic) technology.
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.
Magellan Spine Technologies Receives CE Mark for the DART™ Spinal Disc Annular Repair Technology
Magellan Spine Technologies, Inc. announced today receipt of the CE Mark for the Company’s DART™ Disc Annular Repair Technology System. This patented technology is used to seal the access site in the annulus fibrosus following lumbar spine microdiscectomy.
Minnow Medical Receives CE Mark For Guided Re-Shaping Catheter To Treat Peripheral Artery Disease
Minnow Medical, a developer of innovative products to treat artery disease, announced it has received the CE Mark clearing its disposable catheter for marketing in the European Union.
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.
LDR Announces FDA Clearance of Its ROI-A ALIF Device
LDR, a total spine solution company, announced that it received FDA clearance on Feb. 2 to market its ROI-A™ implant as an anterior lumbar interbody fusion (ALIF) device.
Cardima Receives CE Mark Approval for its Surgical Ablation Probe with Stabilization Sheath
Cardima, Inc., a medical device company focused on the treatment of atrial fibrillation and manufacturer of the Cardima Surgical Ablation System, today announced that it has received CE Mark approval for its Surgical Ablation Probe with Stabilization Sheath.
U.S. advisers reject wider Stryker bone putty use
Stryker Corp’s bone-growth putty for spinal surgery should not be approved for expanded use in a wider population, advisors to federal drug regulators said on Tuesday.
Gore Receives FDA Approval For Larger Diameter, Small Profile AAA Endoprosthesis
W. L. Gore & Associates announced that it has received approval from the US Food and Drug Administration to market a 31 mm diameter version of the GORE EXCLUDER® AAA Endoprosthesis.
OrSense Receives European CE Mark Approval For New Monitoring System
OrSense Ltd. announced today that it has received a European CE Mark approval for its NBM-200MP, a Continuous Non-Invasive Hemoglobin And Pulse Oximetry Monitoring System.
Covidien Receives FDA Clearance For New Pulse Oximeter With OxiMax SPD™ Alert
Covidien announced today 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.
NeuroVasx Receives CE Mark for cPAX Aneurysm Treatment System
NeuroVasx, Inc., a medical device company that develops technologies for the treatment of hemorrhagic and ischemic stroke, announced today that it has received CE Mark for the cPAX Aneurysm Treatment System.