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.
Regulatory
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.
Hospital Defibrillators: AHA Admits Old Models Outperform New
When the rush to new technology may need more consideration: How the American Heart Association may have to resuscitate its policy on defibrillators.
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.
EU Medtech Industry Proposes Changes To Achieve “Smart And Efficient” Medical Devices Legislation.
Medtech industry outlines six steps to guarantee rapid access to safe medical technology while safeguarding innovation
Diabetes Management: Cellnovo In The Sweet Spot
UK Medtech company Cellnovo ticks all the boxes in remote diabetes management.
PleurX Peritoneal Catheter Drainage System Gets Provisional Nod From UK NICE
UK’s National Institute for Health and Clinical Excellence has found that use of PleurX’s peritoneal catheter drainage system is suported by evidence.
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.
Stent Shrinkage Still In Spotlight. FDA Wades In.
FDA is taking a proactive stance and working with manufacturers to understand the issue of longitudinal compression in next generation Drug-Eluting Stents.
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
US Consumer Group Wants (Even) Stronger FDA
US Consumers Union is arguing that Congress should strengthen the Food and Drug Administration’s ability to regulate medical devices in order to improve quality, safety and effectiveness.