Regulatory: Page 250

Kodak DR gets FDA clearance
By AuntMinnie.com staff writers
The Food and Drug Administration has cleared the DirectView DR 7500 digital radiography system from Eastman Kodak Health Group of Rochester, NY.
July 5, 2005
Epix's Vasovist moves closer to market
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals said that the Food and Drug Administration has accepted the firm's May response as a complete response to the FDA's approvable letter for its Vasovist (MS-325) MR blood pool contrast agent.
June 30, 2005
Misonix gets Canadian OK on debrider
By AuntMinnie.com staff writers
Ultrasound developer Misonix has received a Canadian Device License for its ultrasonic wound debridement system.
June 27, 2005
Fluke gets CE Mark
By AuntMinnie.com staff writers
The Radiation Management Services unit of Fluke Biomedical has received the European CE Mark for its Double Check Pro Model 7600, a portable device for therapy beam quality assurance.
June 22, 2005
UltraSPECT gets FDA nod
By AuntMinnie.com staff writers
Israeli nuclear medicine developer UltraSPECT has received Food and Drug Administration 510(k) clearance for its Xpress.cardiac package.
June 15, 2005
Swissray gets FDA OK
By AuntMinnie.com staff writers
Digital radiography developer Swissray International has received Food and Drug Administration 510(k) clearance to market its newest DR system, the ddRCombi Trauma.
June 13, 2005
iCAD nets FDA OK for use with Siemens FFDM
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer iCAD has received Food and Drug Administration 510(k) clearance to package its Second Look Digital system with Siemens Medical Solutions' Mammomat NovationDR full-field digital mammography system.
June 12, 2005
DOBI teams up with Bio-Imaging
By AuntMinnie.com staff writers
Optical breast imaging technology developer DOBI Medical International has entered into a relationship with Bio-Imaging Technologies, which provides medical image management services for clinical trials.
June 8, 2005
Fuji submits PMA for CR mammography
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA of Stamford, CT, has submitted the final module in its premarket approval (PMA) application covering software for conducting computed radiography-based mammography studies.
June 8, 2005
Medtronic gets nod for multipurpose catheter
By AuntMinnie.com staff writers
Medical device developer Medtronic has received Food and Drug Administration 510(k) clearance for its Reliant stent-graft balloon catheter, a multipurpose catheter used for temporary occlusion of large vessels and the expansion of vascular prostheses.
June 7, 2005
Paradigm nets 510(k) for ultrasound biomicroscope
By AuntMinnie.com staff writers
Paradigm Medical Industries of Salt Lake City said it has received Food and Drug Administration clearance for its P60 ultrasound biomicroscope.
June 2, 2005
Cedara B-CAD nets FDA clearance
By AuntMinnie.com staff writers
Imaging software developer Cedara Software, a division of Merge Technologies of Milwaukee, announced that the breast computer-aided detection (CAD) system, Cedara B-CAD, has received Food and Drug Administration 510(k) clearance.
June 1, 2005
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