Regulatory: Page 213

Medtronic wins Japanese clearance for cardiac monitor
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has received clearance in Japan for its cardiac monitor, the Minneapolis company reported.
July 14, 2008
Epix wins South Korean approval of Vasovist
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has received clearance to market its Vasovist MR angiography agent in South Korea.
July 9, 2008
Carestream gets Health Canada nod for CR mammo
By AuntMinnie.com staff writers
Carestream Health has received approval from Health Canada for mammography features for its Kodak DirectView Classic and Elite computed radiography systems.
July 8, 2008
MDS sues AECL for $1.6 billion over Maple reactors
By Wayne Forrest
Canadian healthcare company MDS is suing Atomic Energy of Canada (AECL) for $1.6 billion ($1.58 billion U.S.) as part of an effort to compel AECL to resume work on new nuclear reactors to produce medical isotopes. At the heart of the dispute is AECL's decision in May to discontinue the development of two Maple nuclear reactors for medical isotope production at AECL's Chalk River Laboratories facility in Ontario.
July 8, 2008
FDA clears Bayer's Eovist MRI agent
By AuntMinnie.com staff writers
Bayer HealthCare Pharmaceuticals has received clearance from the U.S. Food and Drug Administration for its gadolinium-based contrast agent, Eovist (gadoxetate disodium).
July 7, 2008
Abbott gets FDA nod for Xience V
By AuntMinnie.com staff writers
Abbott Laboratories has received U.S. Food and Drug Administration clearance for its Xience V everolimus-eluting coronary stent system.
July 2, 2008
Hansen gets FDA nod for CoHesion
By AuntMinnie.com staff writers
Robotic technology developer Hansen Medical has received U.S. Food and Drug Administration clearance to market its CoHesion 3D visualization module for use in complex electrophysiology mapping procedures.
July 1, 2008
Epix resubmits Vasovist NDA
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has resubmitted a new drug application for its MR angiography contrast agent, Vasovist (gadofosveset trisodium).
June 30, 2008
FDA to review Acusphere's Imagify
By AuntMinnie.com staff writers
Ultrasound contrast developer Acusphere said that the U.S. Food and Drug Administration has accepted its Imagify new drug application for review.
June 30, 2008
FDA posts pediatric imaging advisory
By AuntMinnie.com staff writers
Children may be more sensitive to radiation received from medical imaging scans than adults, according to the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH).
June 24, 2008
aycan workstation OsiriX Pro gets CE Mark
By AuntMinnie.com staff writers
aycan Digitalsysteme in Wuerzburg, Germany, has received the European CE Mark for its aycan workstation OsiriX Pro.
June 23, 2008
Accuray wins CyberKnife approval in Japan
By AuntMinnie.com staff writers
Radiotherapy firm Accuray of Sunnyvale, CA, has received approval of its robotic radiosurgery system in Japan, the company reported.
June 18, 2008
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