Regulatory: Page 243

Congress passes steep Medicare imaging cuts
By AuntMinnie.com staff writers
The U.S. House of Representatives last night passed the final version of legislation that cuts Medicare reimbursement for imaging procedures by billions of dollars over the next five years.
February 1, 2006
Guidant gets CE Mark for drug-eluting stent
By AuntMinnie.com staff writers
Interventional device developer Guidant reported that it has received European CE Mark approval for its Xience V everolimus-eluting coronary stent.
January 31, 2006
CardiArc receives FDA nod for SPECT unit
By AuntMinnie.com staff writers
Cardiac imaging device developer CardiArc has received Food and Drug Administration 510(k) clearance for its cardiac SPECT gamma camera.
January 24, 2006
Aurora nets CE Mark, CMDCAS approval
By AuntMinnie.com staff writers
Breast MRI technology developer Aurora Imaging Technology said it has received CE Mark and Canadian Medical Devices Conformity Assessment System (CMDCAS) approval for its Aurora 1.5-tesla dedicated breast MRI system with bilateral rotating delivery of excitation off-resonance (RODEO) capabilities.
January 24, 2006
Draxis radiopharmaceutical approved
By AuntMinnie.com staff writers
Radiopharmaceutical developer Draxis Health has received FDA approval for its supplemental new drug application for sodium iodide I-131 oral capsules.
January 12, 2006
FDA clears Xoft brachytherapy unit
By AuntMinnie.com staff writers
Brachytherapy device developer Xoft has received FDA clearance for a new brachytherapy device designed to target breast cancer.
January 4, 2006
FDA issues warning to Guidant
By AuntMinnie.com staff writers
Interventional device developer Guidant of Indianapolis said it has received a warning letter from the FDA related to its inspection and Form 483 observations of the firm's cardiac rhythm management facility in St. Paul, MN, conducted in September this year.
December 26, 2005
Abbott gets approval for vessel closure device
By AuntMinnie.com staff writers
Interventional device firm Abbott Laboratories has received FDA approval for its StarClose vessel closure system.
December 22, 2005
Swissray gets FDA nod for flat-panel DR unit
By AuntMinnie.com staff writers
Digital radiography vendor Swissray International has received Food and Drug Administration 510(k) clearance for its ddRFormula flat-panel DR system.
December 20, 2005
Palatin suspends NeutroSpec distribution
By AuntMinnie.com staff writers
Contrast agent developer Palatin Technologies said it is voluntarily suspending sales, marketing, and distribution activities of its NeutroSpec radiopharmecutical imaging agent as a result of recently raised safety concerns.
December 18, 2005
Clario gets 510(k)
By AuntMinnie.com staff writers
Imaging processing developer Clario Medical Imaging has received 510(k) marketing clearance from the U.S. Food and Drug Administration for its z3D Contrast Acuity software.
December 13, 2005
New 510(k) for Varian
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received FDA 510(k) clearance for a new proton therapy eye dose calculation module that has been incorporated into company's Eclipse radiation therapy treatment planning system.
December 6, 2005
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