Regulatory: Page 288

FDA clears two GE ultrasound platforms
By AuntMinnie.com staff writers
GE Medical Systems received FDA 510(k) clearances last month on two new ultrasound products, Logiq 5 and Logiq.
February 12, 2002
Siemens gets clearance for Magnetom Trio-3T
By AuntMinnie.com staff writers
Siemens Medical Solutions has received Food and Drug Administration clearance for its Magnetom Trio-3T whole-body MR scanner.
February 11, 2002
Signa Infinity MRI cleared by FDA
By AuntMinnie.com staff writers
GE Medical Systems’ Signa Infinity, a new 1.5-tesla MRI scanner, was given 510(k) clearance January 28 by the FDA, just in time for the vendor to show it off at the 2002 Olympic Winter Games in Salt Lake City.
February 11, 2002
Final 510(k) approvals for January 2002
Issued February 5, 2002
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 January 2002.
February 4, 2002
CADx joins U.S. CAD market
By AuntMinnie.com staff writers
Computer-aided detection provider CADx Medical Systems has received Food and Drug Administration clearance for its Second Look breast cancer CAD system.
January 31, 2002
ElscinTec brings Digimam to North America
By AuntMinnie.com staff writers
Israeli mammography and breast biopsy system provider ElscinTec Systems has begun installations of its Digimam digital spot breast biopsy system at U.S. and Canadian medical centers.
January 24, 2002
Canon gets clearance for portable DR
By AuntMinnie.com staff writers
Digital radiography developer Canon Medical Systems has received Food and Drug Administration 510(k) clearance for its CXDI-31 portable DR sensor.
January 21, 2002
NIBIB gets funding, working group assignments
By AuntMinnie.com staff writers
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has received the funding it needs to make its mission of improving radiology research a reality.
January 21, 2002
New year brings new coding and bundling changes
Several new coding rules went into effect in the U.S. on January 1, bringing changes that could impact your practice's finances, both positively and negatively. Ranging from a new modifier for mammograms to new bundling edits, the new rules impact several modalities.
January 17, 2002
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ISSI receives FDA approval
By AuntMinnie.com staff writers
Computer-aided detection developer Intelligent Systems Software has received Food and Drug Administration clearance for its MammoReader CAD system.
January 16, 2002
SonoSite gets regulatory clearance in Japan
By AuntMinnie.com staff writers
Handheld-ultrasound provider SonoSite of Bothell, WA, has received clearance from the Japanese Ministry of Health, Labor, and Welfare to market and distribute its 180Plus and SonoHeart Plus ultrasound systems.
January 15, 2002
U.S. gives thumbs-down on PET for Alzheimer's
By AuntMinnie.com staff writers
The nuclear medicine community may be convinced of PET's value in diagnosing Alzheimer's disease (AD), but the U.S. government isn't sure enough to pay for it. On Thursday a Medicare panel recommended that the Centers for Medicare and Medicaid Services not cover use of FDG-PET in the diagnosis and management of the disorder.
January 10, 2002
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