Regulatory: Page 245

DOBI Medical International
By Kate Madden Yee
Optical breast imaging technology developer DOBI Medical International of Mahwah, NJ, will display its Dynamic Optical Breast Imaging (DOBI) ComfortScan system.
November 6, 2005
CMS delays, reduces proposed Medicare imaging cuts
By Tracie L. Thompson
The U.S. government's proposal to cut Medicare technical reimbursement for contiguous imaging in both the hospital outpatient and physician office settings has been scaled back or delayed, with the American College of Radiology (ACR) taking credit for the turnabout.
November 3, 2005
GE launches BrightSpeed CT family
By AuntMinnie.com staff writers
GE Healthcare of Chalfont St. Giles, U.K., has launched a new line of CT scanners, called BrightSpeed, that include much of the technology available on GE's volume CT system, LightSpeed VCT, but in a smaller configuration.
November 3, 2005
DOBI signs Beardsworth for PMA trial
By AuntMinnie.com staff writers
DOBI Medical International has hired Beardsworth Consulting Group of Flemington, NJ, to manage the clinical trial of its ComfortScan optical imaging system.
November 2, 2005
MeVis gets 510(k)
By AuntMinnie.com staff writers
The MeVis Center for Medical Diagnostic Systems and Visualization in Bremen, Germany, has received U.S. Food and Drug Administration 510(k) marketing clearance for its software products, MeVis LiverAnalyzer and MeVis LiverViewer.
October 31, 2005
Neurognostics nets FDA nod
By AuntMinnie.com staff writers
Functional MRI technology provider Neurognostics has received a Special 510(k) approval for its MindState fDAD offering.
October 26, 2005
GE gets FDA OK for Lunar iDXA
By AuntMinnie.com staff writers
Multimodality vendor GE Healthcare has received Food and Drug Administration clearance for its new bone mineral density measurement system, Lunar iDXA.
October 25, 2005
Cook gets CE Mark for Zenith
By AuntMinnie.com staff writers
Interventional technology developer Cook has received CE Mark certification for its Zenith Fenestrated AAA endovascular graft, according to the Bloomington, IN-based firm.
October 24, 2005
Double Black, WIDE get 510(k) for mammo LCD
By AuntMinnie.com staff writers
Monitor distributor Double Black Imaging said that its partner WIDE has received Food and Drug Administration 510(k) clearance for its IF2105M LCD system, opening the door for its use in digital mammography applications.
October 20, 2005
Elekta gets Japanese OK for Gamma Knife
By AuntMinnie.com staff writers
Swedish radiation therapy firm Elekta said that the Japanese Ministry for Health, Labour and Welfare has given approval of its Leksell Gamma Knife 4C for noninvasive intracranial radiosurgery.
October 19, 2005
Alliance gets OK for AcuNav reprocessing
By AuntMinnie.com staff writers
Single-use medical device reprocessor Alliance Medical of Phoenix has received Food and Drug Administration 510(k) clearance to reprocess AcuNav ultrasound catheters from Siemens Medical Solutions of Malvern, PA.
October 16, 2005
Elekta gets Canadian IGRT approval
By AuntMinnie.com staff writers
Swedish radiation therapy developer Elekta reported that its Synergy Platform and X-ray Volume Imaging products for image-guided radiation therapy (IGRT) have received approval from Health Canada for sale and use in the country.
October 12, 2005
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