Regulatory: Page 259

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
Confirma brings CADstream to Europe
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer Confirma has received the European CE Mark for its CADstream MRI CAD system.
October 28, 2004
Siemens scores cardiac MR patent
By AuntMinnie.com staff writers
Siemens Medical Solutions has received a U.S. parent for cardiac MR self-gating, a technology designed to eliminate the need to obtain an electrocardiogram (ECG) signal during imaging.
October 27, 2004
Emageon gets OK for digital mammo viewing
By AuntMinnie.com staff writers
Image management firm Emageon has received Food and Drug Administration (FDA) clearance to use its UltraVisual advanced visualization software for soft-copy viewing of digital mammography images in conjunction with FDA-approved display hardware.
October 27, 2004
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