AtriCure has gained FDA’s blessing to commence a study into the impact of its AtriClip Left Atrial Appendage exclusion device on stroke prevention.
Regulatory
PIP Should Not Provoke Knee-Jerk Reforms Says MHRA Chief
“To devise a regulatory system solely about this particular event would be to miss the point that most of the … continue reading “PIP Should Not Provoke Knee-Jerk Reforms Says MHRA Chief”
Cappella’s Sideguard® Coronary Stent Now Approved In India
How to stent a sidebranch. Cappella knows how and has now supplemented CE mark for its Sideguard® system with Indian approval.
UK MHRA Issues Detailed Guidance On All-Metal Hips
MHRA provides advice on follow-up systems for all-metal hips to include testing of all patients with large diameter femoral component and all ASR hips.
Cardiac Science Recalls Certain Automated External Defibrillators
Diligent QC inspections have identified a potential problem with some of Cardiac Science’s AEDs, prompting a recall.
Medical Device Alert: Smiths Medical Level 1® Normothermic IV Fluid Administration Sets And Hotline® Blood And IV Fluid Warming Sets
MHRA has followed up last November’s Field Safety Notices from Smiths Medical, with its own Medical Device Alert pertaining to the company’s Fluid warming and Administration sets.
Double Whammy For Cook With First Japanese Drug-Eluting Peripheral Stent And First Stent For SFA Indication
Cook’s Zilver PTX Becomes First SFA Stent and first Drug-Eluting Peripheral Stent
When Is An App A Medical Device?
Our pages are filling up with medical applications for smartphone/tablet technology, but the regulatory status of many new potential products remains unresolved.
New Steerable Balloon Vertebral Augmentation Device Gains CE Mark
CE mark for clever Steerable Balloon from Osseon, which it claims challenges existing kyphoplasty systems.
Ascendx Spine™ Gets New Board Member, New EU Distributors and FDA Approval
It’s positive news for Ascendx with a new high profile board member, new distributors for its CE marked products in four European countries, and FDA clearance for its Acu-Cut Vertebral Compression Fracture Solution.
Available In EU Since 2004, First US Implant Of Sorin’s Stentless Pericardial Aortic Valve
Eight years after first European implantation Sorin’s Freedom Solo stentless pericardial aortic valve sees its first US patient.
UK MHRA Finally Issues Alert On Covidien Duet One Month After The Company Contraindicates It
It’s only a month, but when people have died because of a medical device technology being found wanting, shouldn’t the UK’s competent authority have acted sooner?
Vascutek Anaconda Field Safety Notice
Vascutek Field Safety Notice issued to ensure safe removal of the bifurcate delivery system when inserting Anaconda and Anaconda ONE-LOK™ AAA grafts.
First FDA Clearance For Drug-Eluting Coronary Stent Use In Heart Attack Patients
Boston’s drug-eluting stents have become the first to gain FDA clearance for use in heart attack patients.
Internal Emails Cast Doubt On DePuy Claims About Reasons For Halting PMA
Will we ever see through the fog in the DePuy ASR case? Internal emails now suggest product performance was a consideration in stopping the PMA and ultimate product withdrawal.
Externalised Defibrillator Leads: State Of Play
Nice piece updating us on the Riata/Sprint Fidelis ICD lead situation.