Regulatory: Page 270

Proxima receives clearance for new MammoSite catheters
By AuntMinnie.com staff writers
Radiation-therapy developer Proxima Therapeutics of Alpharetta, GA, said it has received Food and Drug Administration marketing clearance for elliptical-shaped balloon catheters for its MammoSite catheter-based radiation treatment device.
March 31, 2004
Guidant completes stent trial enrollment
By AuntMinnie.com staff writers
Interventional device developer Guidant has completed enrollment in Spirit First, a clinical trial evaluating the Indianapolis-based firm's second drug-eluting stent system for the treatment of coronary artery disease.
March 31, 2004
Boston Life Sciences gets FDA OK for Altropane trial
By AuntMinnie.com staff writers
Pharmaceutical firm Boston Life Sciences has reached an agreement with the Food and Drug Administration for the phase III clinical trial of its radioimaging agent Altropane.
March 31, 2004
Coalition seeks Medicare coverage for aortic aneurysm screening
By Tracie L. Thompson
Seven organizations from the imaging and surgery fields have convinced four U.S. Congressmen to sponsor a bill directing Medicare to cover ultrasound screening for abdominal aortic aneurysm (AAA).
March 29, 2004
CMS issues interim final rule on self-referral
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has issued the second phase of its final regulations addressing physician referrals to entities with which they have a financial relationship.
March 24, 2004
AuntMinnie.com RIS Digital Communinity Radiology Insider
By Jonathan S. Batchelor
March 7, 2004
NEMA releases gamma probe standard
By AuntMinnie.com staff writers
The National Electrical Manufacturers Association (NEMA) of Rosslyn, VA, has released a published standard for non-imaging intraoperative gamma probes.
March 3, 2004
Infrared Sciences gets FDA nod for infrared breast imaging unit
By AuntMinnie.com staff writers
Infrared Sciences has received Food and Drug Administration 510(k) clearance for its BreastScan IR digital infrared imaging system.
February 25, 2004
Boston Scientific gets Canadian approval
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, has received a license for the sale of its Carotid Wallstent Monorail Endoprosthesis from Health Canada’s Therapeutic Products Directorate.
February 18, 2004
PET's gene-expression role in cervical cancer
By Brian Casey
Taiwanese researchers are using FDG to assess glucose uptake in squamous cell carcinoma of the cervix (SCCC).
February 17, 2004
Medtronic receives FDA OK for stent clinical trial
By AuntMinnie.com staff writers
Medical device manufacturer Medtronic has received FDA clearance to begin the third round of clinical trials on its drug-eluting coronary stent Endeavor.
February 11, 2004
Agenix readies IND application for ThromboView
By AuntMinnie.com staff writers
Australian pharmaceutical developer Agenix is preparing to submit an investigational new drug (IND) application for its ThromboView radiopharmaceutical to the Food and Drug Administration in the second quarter.
February 11, 2004
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