Regulatory

Covidien’s Solitaire FR device has been accepted into US stroke trial on an investigational basis. Company financials look strong and sounds bullish about the forthcoming tax levy.

Safety, cost-effectiveness and quality are the key parameters that lie behind NICE’s approval of four new-generation cardiac computed tomography (CT) scanners for use by the NHS in Coronary Artery Disease patients.

Interventional Spine, Inc. has announced the FDA clearance of its Opticage™ Expandable Intervertebral Body Fusion Device for treatment of degenerative disc disease.

In a shameless attempt to add humour to a difficult situation, medlatest stoops low for a snappy headline.

Apparently ailing 72 year old boss of PIP has now been charged with causing involuntary injury.

Eucomed issues statement updating plans to guide conference plans of its members.

Covidien’s Everflex system, designed to treat long vascular lesions with a single stent, is the subject of an extensive clinical study, interim results of which have been released. The stent is already approved for use in Europe.

The UK’s Department of Health(DOH) has published the terms of reference for its forthcoming review of the PIP scandal.

If we want to introduce one measure to prevent a PIP recurrence, it’s the unannounced site audit.

Details of UK MHRA’s alert relating to St Jude’s Riata defibrillator leads.

Crux Biomedical has announced it has received CE mark approval for its revolutionary inferior vena cava filter with bi-directional retrieval.

Medtronic gets a little closer to market (in USA) with the announcement that CoreValve’s extreme risk group enrollment is now complete.

Opinion piece on how the PIP scandal is flushing out a mixed bag of arguments. But at least we’re thinking about the subject.

A new concept in non-destructive evaluation of articular cartilage has been CE marked by Biomomentum Inc.

Abstract Yet again the CE vs FDA debate is brought into sharp relief with the news that Cohera Medical has … continue reading “FDA Allows CE Marked Glue In On “Investigational Device” Basis”

MHRA comes out fighting “misleading” Lancet