Regulatory: Page 256

Immunomedics gets Canadian nod for LeukoScan
By AuntMinnie.com staff writers
Radiopharmaceutical firm Immunomedics has received clearance for its LeukoScan agent in Canada.
January 18, 2005
CTI gets 510(k) for neuro tool
By AuntMinnie.com staff writers
PET developer CTI Molecular Imaging said that its subsidiary, CTI Mirada Solutions, has received U.S. Food and Drug Administration 510(k) clearance to market Scenium, a quantification application for the analysis of neurological PET scans.
January 17, 2005
Medicare panel endorses national privileging, Stark changes
By Tracie L. Thompson
The Medicare Payment Advisory Commission (MedPAC) is recommending the adoption of standards that would limit who can provide imaging under the U.S. federal health plan. The commission will present its imaging proposals, along with other recommendations such as changes to the Stark law, to Congress in March.
January 17, 2005
Epix gets approvable letter
By AuntMinnie.com staff writers
MR contrast developer Epix Pharmaceuticals has received an approvable letter from the U.S. Food and Drug Administration for its MS-325 MR blood pool contrast agent.
January 13, 2005
ABR outlines recertification program
By AuntMinnie.com staff writers
The American Board of Radiology has outlined its new Maintenance of Certification (MOC) program in an article published simultaneously in multiple radiology journals.
January 9, 2005
ACR to pitch Congress on 'designated physician imagers' for Medicare
By Tracie L. Thompson
As a more comprehensive response to spiraling costs fueled by nonradiologist self-referral, the American College of Radiology is proposing that Congress place limits on who can provide imaging to Medicare patients.
January 5, 2005
Valleylab gets FDA clearance
By AuntMinnie.com staff writers
Valleylab, a business unit of Tyco Healthcare Group, said that the U.S. Food and Drug Administration has issued marketing clearance for its Cool-tip RF ablation system.
January 4, 2005
Imalux Niris gets FDA nod
By AuntMinnie.com staff writers
Optical coherence tomography firm Imalux said its Niris Imaging System recently received market clearance from the U.S. Food and Drug Administration.
January 4, 2005
ArthroCare gets FDA nod for vertebroplasty product
By AuntMinnie.com staff writers
Medical device firm ArthroCare of Sunnyvale, CA, has received 510(k) clearance from the Food and Drug Administration for its Parallax Acrylic Resin with Tracers bone cement opacifier.
December 27, 2004
Resonant gets 510(k)
By AuntMinnie.com staff writers
Radiotherapy device manufacturer Resonant Medical said that its Restitu 3D ultrasound image-guided radiation therapy platform has received 510(k) marketing clearance from the Food and Drug Administration.
December 20, 2004
BrainLab reports new reimbursement code
By AuntMinnie.com staff writers
Radiotherapy developer BrainLab said that users of its ExacTrac X-Ray 6D image-guided radiation therapy system can now receive Medicare reimbursement.
December 20, 2004
NEMA releases DICOM update
By AuntMinnie.com staff writers
The National Electrical Manufacturers Association (NEMA) has released a 16-part update to the DICOM standard.
December 20, 2004
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