Regulatory: Page 251

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
Epix submits response to FDA
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has filed a response to the approvable letter it received in January from the Food and Drug Administration for its MS-325 MR blood-pool contrast agent.
May 22, 2005
IDev Longhorn gets FDA nod, enters European market
By AuntMinnie.com staff writers
Interventional radiology, vascular surgery, and cardiology device developer IDev Technologies said the Food and Drug Administration has given marketing clearance for the Texan Longhorn foreign body retrieval device, the latest addition to IDev's Texan product line.
May 17, 2005
Breakaway nets O-arm 510(k)
By AuntMinnie.com staff writers
Surgical imaging developer Breakaway Imaging has received Food and Drug Administration 510(k) approval for its mobile O-arm imaging system.
May 12, 2005
DOBI posts Q1 numbers
By AuntMinnie.com staff writers
Optical breast imaging firm DOBI Medical International of Mahwah, NJ, reported fiscal 2005 first-quarter (end-March 31) revenues of $62,000, compared with no revenue in the first quarter of fiscal 2004.
May 9, 2005
Conor Medsystems nets CE Mark
By AuntMinnie.com staff writers
Vascular device developer Conor Medsystems has received European CE Mark approval for the use of its UniStar cobalt chromium bare-metal coronary stent for the treatment of de novo coronary artery lesions.
May 9, 2005
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