Regulatory: Page 250

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
FDA OKs expanded use for Kinevac
By AuntMinnie.com staff writers
Bracco Diagnostics has received approval from the Food and Drug Administration to implement a labeling change to Kinevac (sincalide for injection) for all imaging modalities.
May 31, 2005
DOBI to add trial sites
By AuntMinnie.com staff writers
Optical breast imaging firm DOBI Medical International of Mahwah, NJ, said it plans to increase the number of U.S. sites participating in the clinical trial of its ComfortScan breast imaging system from 10 to at least 20 sites.
May 31, 2005
EP MedSystems to expand catheter platform
By AuntMinnie.com staff writers
Electrophysiology device developer EP MedSystems of West Berlin, NJ, said it intends to file a request for premarket approval with the Food and Drug Administration for its Alert CS/RA catheter system.
May 30, 2005
IOM advocates more monitoring of ailing mammo services
By AuntMinnie.com staff writers
In a report released this week, the Institute of Medicine (IOM) has offered its take on how to overhaul U.S. breast cancer screening programs -- greater regulation of screening programs.
May 26, 2005
Midwest weighs incremental Medicare gain for VC
By Eric Barnes
Considering the dim prospects for quick action on a U.S. Centers for Medicare and Medicaid Services national coverage decision that would cover virtual colonoscopy as a cancer screening option, the efforts of a few local carriers represent progress of a sort for virtual colonoscopy.
May 25, 2005
UltraSPECT gets CE Mark
By AuntMinnie.com staff writers
Nuclear medicine developer UltraSPECT of Haifa, Israel, has received the European CE Mark for its Wide Beam Reconstruction (WBR) product family.
May 23, 2005
Vascular Solutions nets 510(k)
By AuntMinnie.com staff writers
Interventional technology developer Vascular Solutions of Minneapolis has received U.S. Food and Drug Administration 510(k) clearance for the sale of 7-French configurations of its Langston dual-lumen catheter.
May 23, 2005
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