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Approval of expanded indication for Boston Scientific’s CRT-Ds recommended
Apr 1, 2010Boston Scientific has shared that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) has unanimously recommended approval of an expanded indication for its cardiac resynchronisation therapy defibrillators (CRT-Ds), including the COGNIS CRT-D.
Being careful with marketing of surgical ablation devices
Apr 1, 2010It has emerged that several medical device makers are being investigated by the U.S. Justice Department over the marketing of surgical-ablation devices.
FDA enters final phase of its transparency initiative
Apr 1, 2010The U.S. Food and Drug Administration (FDA) is soliciting comments from interested persons on ways in which it can increase transparency between the FDA and regulated industry.
Reducing unnecessary radiation exposure from medical imaging
The U.S. Food and Drug Administration (FDA) has come up with an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy.
(Mar 1, 2010)FDA staff may require new device powers
The U.S. Food and Drug Administration (FDA) officials have indicated they face difficulties in reviewing certain medical devices.
(Mar 1, 2010)
TriReme gains clearance for Glider PTA Balloon Catheter
TriReme Medical has received FDA clearance for its newest product, the Glider balloon catheter, for percutaneous transluminal angioplasty (PTA) of lesions in the peripheral vasculature including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.
(Mar 1, 2010)Healthcare introduces pocket-sized visualization tool
GE Healthcare has introduced Vscan, a new visualisation tool developed to provide physicians with imaging capabilities at the point-of-care.
(Mar 1, 2010)
R-Squared ties up with IMS Health
R-Squared has formed a strategic alliance with IMS Health to help pharmaceutical and medical device manufacturers comply with the growing body of state transparency and marketing disclosure laws, known as “aggregate spend” reporting laws.
(Mar 1, 2010)