Durable ePTFE Endoprosthesis Designed for Endovascular Repair of the Descending Thoracic Aorta Provides Conformability without Compromise
Regulatory
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Early Clinical Evaluation Of Medical Devices In USA: FDA Issues Draft Guidance Document
Draft Guidance for Industry and Food and Drug Administration Staff – Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including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
Transcatheter Cardiovascular Therapeutics conference 2011: Live link of UK case highlights FDA’s caution on Sapien Aortic Valve PMA.
Update from TCT2011 sourced from an article by Medical Device Daily
Abbott Receives CE Mark for New Hepatitis Test
Abbott announced it has received CE Mark approval for its new, highly sensitive diagnostic test for detection of hepatitis B surface antigen.
Cordis Empira PTCA Catheters get 510(k) approval for Coronary Artery Disease
Cordis Corporation has announced EMPIRA™ and EMPIRA™ NC RX PTCA Dilatation Catheters have received 510(k) regulatory clearance for the treatment of coronary artery disease.
Medical Device Regulation: “FDA is tougher than CE mark” shock
According to MedCity News, the US site covering news, opinion and analysis from today’s medical cities; “The medical device industry seems to be in love with Europe”.
Medical Device Alert on Venturi Air Entrainment Jet Adapters manufactured by Lifecare Hospital Supplies Ltd
UK MHRA has issued a Medical Devices Alert on Venturi Air Entrainment Jet Adapters supplied in kits with Oxygen facemasks and Tubing, manufactured by Lifecare Hospital Supplies Ltd.
Edwards Receives FDA Approval to Expand U.S. Clinical Trial of Next-Generation Transcatheter Valve
Already approved in Europe since March 2010, Edwards’ Sapien XT valve now gains further investigational device study arm in USA.
Medical Device Alert on Crystal® Metal Disposable Laryngoscope Blades
Medical Device Alert: Crystal® Metal disposable laryngoscope blades (size Mac 4) manufactured by Penlon Ltd (MDA/2011/101)
CE Mark for New Lead Enhances abiliti® Food Sensing/Gastric Stimulation System
IntraPace, Inc. has announced that it has received CE Mark for the LGL102, a new gastric stimulation/food sensing lead designed to work with the innovative abiliti(R) system, an implantable weight loss management system.
FDA Reports Growth in Medical Device Adverse Events
Medtech Business reports FDA’s observations that growth in reported serious adverse events has outpaced revenue growth by 8% each year in the past decade.
NICE recognises the clinical potential of the EOS 2D/3D imaging system, encouraging use in the specialist research setting
UK’s NICE has published diagnostic guidance encouraging the use of the EOS 2D/3D imaging system in specialist research settings.
“New” Indian Regulatory Rules Mean Surgical Staplers Are Now Drugs
Indian regulations step back in time as more devices fall under pharmaceutical controls
CE Mark for a New Embolic Protection System During TAVI
Claret Medical Announces CE Mark of a New Embolic Protection System to Address Stroke During Transcatheter Aortic Valve Intervention