Rayner Intraocular Lenses Limited, the world’s original manufacturer of IOLs, has received CE Mark approval for the Sulcoflex® Multifocal Toric IOL.
Approval/Clearance
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.
Ascendx Spine™ Appoints Pilar Debelius-Kinsey As Sales And Marketing Manager, Europe
Vertebral Compression Fracture Specialist Ascendx Spine™, has appointed Maria Pilar Debelius-Kinsey as Sales and Marketing Manager, Europe, effective immediately.
FDA Provides Info On NeurX Diaphragm Pacing system
Following FDA’s approval under Humanitarian Device Exemption rules of Synapse Biomedical’s NeurX Diaphragm Pacing System in September it has now released further information.
Aptus HeliFX EndoStapling System Cleared By FDA
Aptus HeliFX Endograft Fixation Device follows May CE Mark with FDA approval.
Diabetes Management: Cellnovo In The Sweet Spot
UK Medtech company Cellnovo ticks all the boxes in remote diabetes management.
BIOTRONIK Introduces the World’s First and Only MRI Compatible Implantable Defibrillators
New MRI Compatible Lumax 740 series ICDs with ProMRI® offer extended longevity and BIOTRONIK Home Monitoring® for improved patient care.
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.
FDA Publishes Further Information Following Approval Of Edwards Sapien Valve
FDA has followed up its approval of Edwards’ Sapien Transcatheter Aortic Valve with information pertaining to the approval and use of the device.
CE Mark For NeoVasc Reducer™ Product To Treat Refractory Angina
Neovasc Inc. has announced that it has received the CE mark designation for its Reducer™ product for the treatment of refractory angina.
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.
STAAR Surgical Receives CE Mark Approval For Its Toric Collamer® IOL
CE Mark for Staar Surgical Allows Company to Expand its Presence in the Premium IOL Market in Europe with the nanoFLEX(TM) Toric IOL. First Shipments are Scheduled for Q1 2012
Gore Receives FDA Approval for Conformable GORE® TAG® Thoracic Endoprosthesis
Durable ePTFE Endoprosthesis Designed for Endovascular Repair of the Descending Thoracic Aorta Provides Conformability without Compromise
Ethicon Endo-Surgery Receives 510(k) Clearance for New ENSEAL® G2 Curved and Straight Tissue Sealers Line — Broadest Range of Advanced Bipolar Tissue Sealers Available for Open and Minimally Invasive Surgery
Ethicon Endo-Surgery, Inc. has announced U.S. FDA 510(k) clearance of its innovative ENSEAL® G2 Curved and Straight Tissue Sealers
Vascular Designs’ IsoFlow™ Infusion Catheter Receives CE Mark Approval
Vascular Designs, Inc.has announced that its IsoFlow™ Infusion Catheter has received CE Mark approval for use in Europe and Canada
Early Clinical Evaluation Of Medical Devices In USA: FDA Issues Draft Guidance Document
Draft Guidance for Industry and Food and Drug Administration Staff – Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies