Regulatory: Page 241

Del Medical gets Chinese sign-off
By AuntMinnie.com staff writers
Del Medical Systems Group's manufacturing facilities in Franklin Park, IL, have completed the final testing required by Beijing-based China Quality Certification Center regulators for digital production.
March 16, 2006
Biosense Webster, Cordis get Noga XP FDA clearance
By AuntMinnie.com staff writers
Cardiac technology developer Biosense Webster and Johnson & Johnson subsidiary Biologics Delivery Systems Group, Cordis has received U.S. Food and Drug Administration clearance to market a cardiac 3D imaging device, the Noga XP cardiac navigation system.
March 15, 2006
GE receives Innova 510(k) clearance
By AuntMinnie.com staff writers
GE Healthcare said that the U.S. Food and Drug Administration has provided 510(k) clearance for its Innova 3131(IQ) and 2121(IQ) digital flat-panel biplane imaging systems.
March 13, 2006
ev3 stent gets FDA, CE stent nods for Protege
By AuntMinnie.com staff writers
Interventional device firm ev3 of Plymouth, MN, has received Food and Drug Administration 510(k) clearance to market its Protege EverFlex self-expanding stent system for the palliative treatment of malignant neoplasms in the biliary tree.
March 9, 2006
Guidant launches new stent
By AuntMinnie.com staff writers
Interventional device developer Guidant has launched the RX HercuLink Elite biliary stent system in the U.S., following Food and Drug Administration 510(k) clearance.
March 9, 2006
Ultrasound scanner bill introduced in CA
By AuntMinnie.com staff writers
California Assembly member Ted Lieu has introduced legislation aimed at limiting the sale of ultrasound scanners in California to only licensed medical professionals.
March 8, 2006
Boston Scientific submits final Liberté PMA module
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has submitted the final module of a premarket approval (PMA) application to the Food and Drug Administration (FDA) for its Taxus Liberté paclitaxel-eluting coronary sent system.
March 8, 2006
Point Biomedical agent accepted for FDA review
By AuntMinnie.com staff writers
Ultrasound contrast developer Point Biomedical said that the Food and Drug Administration has accepted its new drug application (NDA) for review of the firm's Cardiosphere myocardial perfusion agent.
February 27, 2006
Senate version of CARE bill introduced
By AuntMinnie.com staff writers
The effort to establish nationwide education and credentialing requirements for U.S. radiologic technologists took another step forward this month with the introduction of a version of the Consumer Assurance of Radiologic Excellence (CARE) bill in the U.S. Senate.
February 23, 2006
FDA completes Guidant manufacturing inspection
By AuntMinnie.com staff writers
Interventional device developer Guidant said that the U.S. Food and Drug Administration has completed its inspection of the firm's St. Paul, MN-based cardiac rhythm management facilities.
February 22, 2006
Rubidium-based PET may finally get its due
By Wayne Forrest
After languishing in the clinical shadows for the last 10 years, rubidium is starting to catch the attention of nuclear medicine specialists. The radiopharmaceutical can thank the Centers for Medicare and Medicaid Services (CMS) for its revival.
February 22, 2006
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Fuji gets CR mammo approval in Canada
By AuntMinnie.com staff writers
Fujifilm Medical Systems has obtained a Class III license from Health Canada for the distribution of its FCR Profect CS computed radiography system for mammography use in Canada.
February 20, 2006
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