Regulatory: Page 242

NAS receives Chinese clearance for IGRT device
By AuntMinnie.com staff writers
Radiation therapy firm North American Scientific (NAS) has received regulatory approval from the People's Republic of China State Food and Drug Administration (SFDA) to sell its BAT SXi, an ultrasound-based localization system used to view cancerous tumors prior to the delivery of radiation therapy.
February 20, 2006
Lawsuit takes aim at Deficit Reduction Act
By AuntMinnie.com staff writers
An Alabama attorney has filed a lawsuit seeking to overturn the Deficit Reduction Act of 2005, giving radiology advocates a sliver of hope that the legislation could be invalidated before it implements billions in Medicare reimbursement cuts.
February 20, 2006
Technological advances drive new 3D CPT codes
By Cynthia E. Keen
If your imaging practice frequently bills for 3D image reconstruction, you should be aware of recent changes in current procedural terminology (CPT) codes for advanced visualization techniques. The changes reflect the rapid pace at which 3D is being adopted for routine clinical use.
February 20, 2006
Planar ships first E4c
By AuntMinnie.com staff writers
Display vendor Planar Systems has received Food and Drug Administration 510(k) clearance for its Dome E4c 4-megapixel color display.
February 12, 2006
NAS gets FDA clearance for brachytherapy needle kit
By AuntMinnie.com staff writers
Radiation therapy firm North American Scientific (NAS) has received Food and Drug Administration clearance to market its Prospera SurTrak line of brachytherapy products for the treatment of prostate cancer.
February 6, 2006
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
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