Regulatory: Page 261

FDA OKs use of Second Look CAD with Selenia
By AuntMinnie.com staff writers
Women's imaging vendor Hologic and computer-aided detection developer iCAD have received Food and Drug Administration clearance to use iCAD's Second Look Digital CAD technology with Hologic's Selenia full-field digital mammography (FFDM) system.
September 12, 2004
Final 510(k) decisions for August 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for August 2004:
September 6, 2004
CMS to cover carotid artery stenting
By AuntMinnie.com staff writers
The Centers for Medicare & Medicaid Services (CMS) said it intends to expand coverage of percutaneous transluminal angioplasty of the carotid artery with placement of an FDA-approved carotid stent.
September 1, 2004
Guidant stent gets FDA clearance
By AuntMinnie.com staff writers
Interventional-device firm Guidant has received Food and Drug Administration clearance for a new carotid stent system designed to reduce the risk of stroke associated with carotid artery disease.
August 31, 2004
FDA approves GE's Excite MRI technology
By AuntMinnie.com staff writers
GE Healthcare has received clearance from the Food and Drug Administration to market its Excite platform, an MRI technology that speeds up the data-processing pipeline to enable more advanced exams, the Waukesha, WI-based vendor said.
August 30, 2004
Barco gets FDA nod for flat-panel mammo
By AuntMinnie.com staff writers
Diagnostic display provider Barco has received Food and Drug Administration 510(k) clearance for its Coronis 5MP Mammo LCD display, according to the Kortrijk, Belgium-based firm.
August 30, 2004
DR Systems gets nod for digital mammo reading
By AuntMinnie.com staff writers
PACS vendor DR Systems has received Food and Drug Administration clearance for diagnostic reading of digital mammography images on its PACS network.
August 30, 2004
FDA approves Siemens FFDM system
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions has received FDA premarket approval for its Mammomat Novation DR full-field digital mammography system.
August 22, 2004
Medicsight to bring Lung CAR to market
By AuntMinnie.com staff writers
Image analysis software developer Medicsight has received Food and Drug Administration clearance for its Lung Computed Assisted Reader (CAR) software.
August 15, 2004
Hologic gets FDA nod for SecurViewDX
By AuntMinnie.com staff writers
Women's imaging firm Hologic has received Food and Drug Administration marketing clearance for its SecurViewDX breast imaging workstation, according to the Bedford, MA-based company.
August 11, 2004
Final PMA decisions for July 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of premarket approvals (PMA), product development protocols (PDP), supplement and notice decisions from the previous month. The following decisions were rendered for July 2004.
August 11, 2004
Final 510(k) decisions for July 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for July 2004:
August 9, 2004
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