Regulatory: Page 173

AngioDynamics receives warning letter
By AuntMinnie.com staff writers
Interventional technology developer AngioDynamics has received a warning letter from the U.S. Food and Drug Administration regarding marketing of its NanoKnife surgical ablation system.
January 25, 2011
Medicatech gets FDA nod for DR detectors
By AuntMinnie.com staff writers
Digital x-ray developer Medicatech USA has received U.S. Food and Drug Administration 510(k) clearance for new flat-panel digital radiography (DR) detectors.
January 25, 2011
Philips nets CE Mark for PET/MRI
By AuntMinnie.com staff writers
Philips Healthcare has received the CE Mark for its whole-body Ingenuity TF PET/MRI system.
January 24, 2011
CMS continues to eye imaging overutilization
By Kate Madden Yee
The U.S. Centers for Medicare and Medicaid Services (CMS) continues to keep its eye on imaging utilization: The agency is planning a meeting for January 31 to discuss whether to add new imaging exams to a data reporting program designed to track overutilization.
January 24, 2011
Maryland court upholds state self-referral law
By AuntMinnie.com staff writers
The Maryland State Court of Appeals has ruled against the practice of self-referral of advanced medical imaging and radiation therapy, reaffirming the state's physician self-referral law, according to the American College of Radiology.
January 24, 2011
Study finds USPSTF mammo guidelines would increase death rate
By Kate Madden Yee
Nearly 65,000 more women would lose their lives from breast cancer if the U.S. Preventive Services Task Force's (USPSTF) controversial 2009 guidelines on screening mammography were adopted on a widespread basis, according to a study in the February issue of the American Journal of Roentgenology.
January 24, 2011
FDA panel gives nod to Bayer's Gadovist MRI contrast agent
By Wayne Forrest
An advisory committee of the U.S. Food and Drug Administration today voted unanimously to recommend approval for Bayer HealthCare Pharmaceuticals' Gadovist 1.0 (gadobutrol), a gadolinium-based contrast agent for contrast-enhanced MRI of the central nervous system.
January 20, 2011
FDA panel gives Amyvid PET agent conditional approval
By Wayne Forrest
With a unanimous 16-0 decision, an advisory committee of the U.S. Food and Drug Administration voted on January 20 to conditionally recommend approval of Eli Lilly's PET imaging agent Amyvid (florbetapir) for detecting beta amyloid plaque deposits that could be precursors to Alzheimer's disease.
January 19, 2011
Elekta awarded CE Mark
By AuntMinnie.com staff writers
Swedish oncology firm Elekta said it has received CE Mark clearance for its Fraxion patient-specific cranial immobilization system.
January 18, 2011
NCI launches SBIR regulatory program
By AuntMinnie.com staff writers
The U.S. National Cancer Institute (NCI) has launched a new initiative under its Small Business Innovation Research (SBIR) program to help small businesses navigate the U.S. Food and Drug Administration approval process.
January 16, 2011
GE gets FDA nod for DaTscan
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration clearance for its DaTscan (ioflupane I-123 injection) radiopharmaceutical agent.
January 13, 2011
Stereotaxis adds CE Mark
By AuntMinnie.com staff writers
Image-guided interventional surgery firm Stereotaxis has received the European CE Mark for its Vdrive robotic navigation system.
January 10, 2011
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