Regulatory: Page 256

CSI gets 510(k), European trial approval
By AuntMinnie.com staff writers
Interventional device developer Cardiovascular Systems (CSI) of Minneapolis has received 510(k) marketing clearance from the U.S. Food and Drug Administration for its orbital atherectomy device to remove tissue-causing stenosis in synthetic AV shunts.
February 2, 2005
Neurognostics nets 510(k)
By AuntMinnie.com staff writers
Functional MRI (fMRI) applications developer Neurognostics has received 510(k) market clearance from the U.S. Food and Drug Administration for its MindState functional data acquisition device (fDAD).
February 1, 2005
Combidex gets FDA review date
By AuntMinnie.com staff writers
MR contrast developer Advanced Magnetics and biopharmaceutical firm Cytogen reported that the FDA's Oncologic Drugs Advisory Committee is scheduled to review the regulatory filing for Combidex, Advanced Magnetics' investigational MRI contrast agent, on March 3, this year.
January 31, 2005
Medicare expands PET coverage for cervical cancer
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it will extend Medicare coverage for the use of an FDG-PET scan for staging newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extrapelvic metastasis.
January 30, 2005
Implant Sciences gets 510(k) for ytterbium-169
By AuntMinnie.com staff writers
Radiation oncology and interventional cardiology firm Implant Sciences said it has received clearance of its 510(k) application from the U.S. Food and Drug Administration.
January 26, 2005
IDSI alters course on FDA PMA
By AuntMinnie.com staff writers
CT laser mammography (CTLM) developer Imaging Diagnostic Systems (IDSI) in a letter to shareholders today said that it is altering its course for obtaining U.S. Food and Drug Administration premarket approval (PMA) for its CTLM device.
January 26, 2005
Fluorescent system clearance for Novadaq
By AuntMinnie.com staff writers
Canadian cardiovascular imaging developer Novadaq Technologies of Toronto has received 510(k) clearance from the U.S. Food and Drug Administration for its Spy intraoperative imaging system.
January 24, 2005
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
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