Regulatory: Page 260

Shared PET application gets FDA nod
By AuntMinnie.com staff writers
PET services provider Shared PET Imaging has received Food and Drug Administration approval of its ClarityFusion software, according to the Canton, OH-based firm.
November 21, 2004
EDDA gets FDA nod for chest software
By AuntMinnie.com staff writers
Imaging software developer EDDA Technology of Princeton, NJ, has received Food and Drug Administration clearance for its IQQA-Chest software for analysis of digital radiography chest images.
November 21, 2004
Orthocrat gets FDA nod for TraumaCad
By AuntMinnie.com staff writers
Israeli orthopedic planning software developer Orthocrat has received Food and Drug Administration 510(k) clearance for the latest version of its TraumaCad software.
November 18, 2004
Biofield makes regulatory progress on BDS
By AuntMinnie.com staff writers
Breast cancer detection developer Biofield of Atlanta is making progress in bringing its Breast Cancer Diagnostic System (BDS) to the U.S. market.
November 15, 2004
FDA clears 3D CT bronchoscopy
By AuntMinnie.com staff writers
Peripheral areas of the lung are virtually unreachable with standard bronchoscopy procedures, but Tel Aviv, Israel-based superDimension has developed an FDA-cleared navigation system for guiding endoscopic instruments in the pulmonary tract.
November 14, 2004
FDA clears EDDA's digital chest software
By AuntMinnie.com staff writers
New imaging software company EDDA in Princeton Junction, NJ, has received Food and Drug Administration 510(k) clearance for software for the review of digital x-ray chest images.
November 7, 2004
Hitachi wins clearance for SceptreP3 PET/CT
By AuntMinnie.com staff writers
Hitachi Medical Systems America has received the Food and Drug Administration's 510(k) clearance to market its new SceptreP3 PET/CT system in the U.S.
November 3, 2004
Varian adds 3D-guided imaging to linacs
By AuntMinnie.com staff writers
Varian Medical Systems has received Food and Drug Administration 510(k) clearance for conebeam CT imaging using the company's On-Board Imager device for real-time image-guided radiation therapy (IGRT) with its linear accelerators.
November 3, 2004
Radiologists (mostly) cheer as insurers set imaging rules
By Tracie L. Thompson
The concept isn't new, but "privileging" of imaging providers is gaining steam among payors. The trend may force changes in radiology practices, but it's more likely to curb imaging self-referral, making health plans the unexpected protectors and champions of imaging specialists.
November 3, 2004
Medicare announces payment rates and policy changes
By AuntMinnie.com staff writers
The Centers for Medicare and Medicaid Services (CMS) this week announced its final rule establishing a 3.3% increase in new payment rates for outpatient services starting January 1.
November 2, 2004
Analogic gets 510(k) for new flat-panel detector
By AuntMinnie.com staff writers
Analogic has received 510(k) clearance from the Food and Drug Administration for the GR17 flat-panel digital detector developed by Analogic subsidiary Anrad.
November 1, 2004
SonoVue reinstated for echo use
By AuntMinnie.com staff writers
The SonoVue ultrasound contrast agent from Bracco of Milan, Italy, has been reinstated for use in echocardiography applications in Europe by the Commission of the European Communities, the executive body of the European Union.
October 31, 2004
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