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POLICY DEVELOPMENTS
FDA issues guidelines on devices used to treat blocked heart arteries
The US Food and Drug Administration has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries
Endeavor Zotarolimus-Eluting Coronary Stent approved
The Endeavor is the first drug-eluting stent approved since 2004 and the first since FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents.
TODAY'S NEWS
  Ranbaxy, Cadila get FDA permit to sell drugs in US
  Abbott launches device to help fast vessel closure
  Pall Corp. appoints Felix Negron to head manufacturing
  Murdoch University, Info Kinetics sign MoU
  Pfizer launches cancer research institute in Australia
  Simcere gets SFDA approval of biapenem injection Anxin
 
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Issue: April 30, 2008
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China steps up the pace: India and China are racing to become lucrative pharmaceutical markets for global players
 
 
 
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POLICIES
 
FDA issues guidelines on devices used to treat blocked heart arteries
The US Food and Drug Administration has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries
 
Endeavor Zotarolimus-Eluting Coronary Stent approved
The Endeavor is the first drug-eluting stent approved since 2004 and the first since FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents.
 
India to introduce medical devices regulation bill
The Department of Science & Technology, Government of India has proposed to bring in a new legislation to enforce uniform and effective standards of Medical Devices throughout the country. This will ensure that substandard devices are not exported
 
FDA licenses 15 new blood typing tests
The US FDA has licensed Alba Bioscience's 15 new blood typing tests
 
FDA approves GE mobile mammography system
GE Healthcare has received an approval from the US FDA for its new mobile mammography product that will improve access to breast cancer screening
 
Japan approves St Jude Medical's Angio-Seal
St Jude Medical has received regulatory approval from the Ministry of Health, Labor and Welfare for its Angio-Seal STS Plus Vascular Closure device
 
Japan approves Volcano's Intravascular Ultrasound
This is Volcano's first Integrated Intravascular Ultrasound (IVUS) System that can be integrated into new or existing cath labs. IVUS guidance improves patient outcomes when used as part of routine stenting technique
 
FDA approves artificial cervical disc
The Prestige Cervical Disc is the first US FDA approved artificial cervical disc for the treatment of cervical degenerative disc disease
 
China Medical to conduct cancer therapy trials in US
China Medical Technologies has received a conditional approval from US FDA to begin clinical trials using its high intensity focused ultrasound (HIFU) tumor therapy systems
 
Japan approves St Jude Medical CRT-D products
St Jude Medical has received approval from Japan MHLW for two new cardiac resynchronization therapy defibrillators to treat heart failure patients
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