Regulatory: Page 274

Boston Scientific’s Taxus stent receives Canadian approval
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, has received approval from Health Canada’s Therapeutic Products Directorate for the sale of its Taxus Express2 paclitaxel-eluting coronary stent system in Canada.
September 11, 2003
B. Braun injector system gets 510(k)
By AuntMinnie.com staff writers
B. Braun Medical has received Food and Drug Administration clearance for its Ultrasite needle-free IV system for interventional radiology applications.
September 10, 2003
Boston Scientific, CryoVascular form alliance
By AuntMinnie.com staff writers
Boston Scientific and CryoVascular Systems have signed a series of agreements.
September 10, 2003
Siemens gets OK for Oncor Avant-Garde
By AuntMinnie.com staff writers
Siemens Medical Solutions has received Food and Drug Administration 510(k) clearance for its Oncor Avant-Garde linear accelerator.
September 9, 2003
Cordis stent gets FDA OK
By AuntMinnie.com staff writers
Interventional technology developer Cordis Endovascular has received Food and Drug Administration clearance for the use of its S.M.A.R.T. Nitinol stent and S.M.A.R.T. Control Nitinol stent for primary stenting of the iliac arteries.
September 4, 2003
Henry Schein divests PMA Bode
By AuntMinnie.com staff writers
Healthcare products and services provider Henry Schein of Melville, NY, has entered into an agreement to divest its PMA Bode business.
September 1, 2003
CADx gets FDA nod for Second Look systems
By AuntMinnie.com staff writers
Computer-aided detection developer CADx Systems has received Food and Drug Administration clearance for its Second Look Digital and Second Look AD systems.
August 12, 2003
Bard gets added clearance for vena cava filter
By AuntMinnie.com staff writers
Interventional technology developer C.R. Bard has received Food and Drug Administration clearance to market its Recovery vena cava filter as a removable device.
August 11, 2003
Aurora receives 510(k) for increased field strength
By AuntMinnie.com staff writers
Breast MRI developer Aurora Imaging Technology of North Andover, MA, has received Food and Drug Administration 510(k) marketing clearance for a new, 1.5-tesla version of its dedicated breast MRI scanner.
August 6, 2003
DraxImage begins Infecton Phase II trials
By AuntMinnie.com staff writers
DraxImage, a division of radiopharmaceutical firm Draxis Health of Mississauga, Ontario, has received Health Canada approval to begin phase II clinical studies of its radiopharmaceutical Infecton.
July 30, 2003
Advanced Magnetics gets U.S. patent
By AuntMinnie.com staff writers
Contrast agent developer Advanced Magnetics has received a U.S. patent related to the company’s next-generation iron oxide technology.
July 30, 2003
EP MedSystems seeks 510(k) for integrated system
By AuntMinnie.com staff writers
Electrophysiology device developer EP MedSystems has requested a 510(k) regulatory clearance filing with the Food and Drug Administration for the integration of its WorkMate intracardiac ultrasound catheter system with Boston Scientific’s Realtime Position Management technology.
July 23, 2003
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