Regulatory: Page 261

Preparation key to surviving MQSA inspections
By Erik L. Ridley
PHILADELPHIA - Inspections to measure compliance with the Mammography Quality Standards Act (MQSA) can be stressful, but proper preparation can alleviate much of the anxiety, according to Bonnie Rush, president of Breast Imaging Specialists (BIS) in San Diego.
October 3, 2004
2002 09 30 15 13 07 706
Schering gets EU approval for Primovist
By AuntMinnie.com staff writers
German pharmaceutical firm Schering has received European Union marketing approval for its Primovist MR liver imaging agent.
September 29, 2004
IDSI receives Chinese OK for CTLM
By AuntMinnie.com staff writers
Imaging Diagnostic Systems has received Chinese State Food and Drug Administration (SFDA) marketing approval for its CT laser mammography system (CTLM).
September 26, 2004
ComSynTech nets radiology workflow patent
By AuntMinnie.com staff writers
Information management systems firm Communication Synergy Technologies (ComSynTech) has received a U.S. patent covering its InForm radiology workflow offering.
September 23, 2004
Proxima gets FDA OK for new MammoSite
By AuntMinnie.com staff writers
Radiation therapy developer Proxima Therapeutics has received Food and Drug Administration clearance for the next generation of its MammoSite balloon catheter device.
September 21, 2004
Draxis begins Infecton trial
By AuntMinnie.com staff writers
Radiopharmaceutical developer DraxImage has received Food and Drug Administration approval to begin a phase II clinical study of its Infecton molecular imaging agent, designed to detect and localize difficult-to-diagnose infection in the body.
September 20, 2004
FDA clears IDC's Xplorer 1600
By AuntMinnie.com staff writers
Canadian digital x-ray developer Imaging Dynamics has received the U.S. Food and Drug Administration's 510(k) clearance for its Xplorer 1600 digital radiography unit.
September 19, 2004
FDA OKs use of Second Look CAD with Selenia
By AuntMinnie.com staff writers
Women's imaging vendor Hologic and computer-aided detection developer iCAD have received Food and Drug Administration clearance to use iCAD's Second Look Digital CAD technology with Hologic's Selenia full-field digital mammography (FFDM) system.
September 12, 2004
Final 510(k) decisions for August 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for August 2004:
September 6, 2004
CMS to cover carotid artery stenting
By AuntMinnie.com staff writers
The Centers for Medicare & Medicaid Services (CMS) said it intends to expand coverage of percutaneous transluminal angioplasty of the carotid artery with placement of an FDA-approved carotid stent.
September 1, 2004
Guidant stent gets FDA clearance
By AuntMinnie.com staff writers
Interventional-device firm Guidant has received Food and Drug Administration clearance for a new carotid stent system designed to reduce the risk of stroke associated with carotid artery disease.
August 31, 2004
FDA approves GE's Excite MRI technology
By AuntMinnie.com staff writers
GE Healthcare has received clearance from the Food and Drug Administration to market its Excite platform, an MRI technology that speeds up the data-processing pipeline to enable more advanced exams, the Waukesha, WI-based vendor said.
August 30, 2004
Previous Page
Page 261 of 303
Next Page