Regulatory: Page 242

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
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
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