Regulatory: Page 253

Mammo display clearance for Siemens
By AuntMinnie.com staff writers
Imaging display developer Siemens Display Technologies of Lafayette, CO, has received 510(k) approval from the Food and Drug Administration for its 5-megapixel liquid-crystal display for mammography applications.
March 27, 2005
FDA requests Combidex information
By AuntMinnie.com staff writers
MR contrast developer Advanced Magnetics of Cambridge, MA, reported that it has received an approvable letter from the Food and Drug Administration regarding Combidex, its investigational functional molecular imaging agent.
March 23, 2005
FDA approval for Barco's Nio displays
By AuntMinnie.com staff writers
Display provider Barco has received Food and Drug Administration 510(k) clearance for its Nio family of diagnostic display systems.
March 23, 2005
Elekta gets MEG approval in Canada
By AuntMinnie.com staff writers
Swedish radiation therapy and magnetoencephalography developer Elekta has received clearance to market its Neuromag system in Canada.
March 22, 2005
Siemens gets clearance for treatment table
By AuntMinnie.com staff writers
Siemens Medical Solutions has received Food and Drug Administration 510(k) clearance for 550 TxT, a radiation therapy treatment table.
March 21, 2005
RealTimeImage gets additional Prism clearance
By AuntMinnie.com staff writers
Image distribution technology provider RealTimeImage has received Food and Drug Administration 510(k) clearance to market its iPACS Prism v5.0 PACS network for primary mammography reading.
March 20, 2005
CARE bill reintroduced in U.S. Congress
By AuntMinnie.com staff writers
Legislation that would establish education and credentialing requirements for radiologic technologists in the U.S. has been reintroduced in the House of Representatives.
March 17, 2005
CMS adds PTA with stenting coverage
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it is expanding coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stent placement for patients who are at high risk for carotid surgery.
March 17, 2005
U.S. Congress hears debate over federal imaging standards
By Tracie L. Thompson
The debate over who should be able to provide imaging services in America reached Capitol Hill today, with the American College of Radiology (ACR) at odds with other medical specialists and, to a lesser degree, the imaging vendor community.
March 16, 2005
Suros gets FDA clearance for breast tissue removal
By AuntMinnie.com staff writers
Interventional technology developer Suros Surgical Systems has received additional Food and Drug Administration clearance for its ATEC breast biopsy system.
March 16, 2005
Varian gets FDA OK for nasopharynx applicator set
By AuntMinnie.com staff writers
Varian Medical Systems has received Food and Drug Administration clearance for its Nasopharynx Applicator Set, which is designed to deliver localized radiation therapy in the upper throat area.
March 13, 2005
DOBI reports year-end results
By AuntMinnie.com staff writers
Optical breast imaging developer DOBI Medical International of Mahwah, NJ, reported financial results for fiscal 2004 that show the development-stage company beginning to generate revenue for the first time.
March 13, 2005
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