Regulatory: Page 270

R2 gets FDA panel nod for lung CAD
By AuntMinnie.com staff writers
A Food and Drug Administration advisory committee panel has voted unanimously to recommend approval for R2 Technology's ImageChecker CT computer-aided detection (CAD) system.
February 3, 2004
Chase gets FDA OK for 3-D cardiac MRI software
By AuntMinnie.com staff writers
Cardiac device manufacturer Chase Medical has received Food and Drug Administration 510(k) marketing clearance for Simon, the company's cardiac 3-D analysis system.
February 3, 2004
Sectra breast workstation receives 510(k)
By AuntMinnie.com staff writers
Swedish PACS and digital mammography developer Sectra has received U.S. Food and Drug Administration 510(k) marketing clearance for its IDS5 dedicated breast imaging workstation.
January 28, 2004
IDSI lands another patent
By AuntMinnie.com staff writers
Laser breast imaging developer Imaging Diagnostic Systems has received its 15th U.S. patent.
January 27, 2004
CMS adopts NPI as unique identifier
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it has adopted the National Provider Identifier (NPI) as the standard unique health identifier for healthcare providers to use in filing and processing healthcare claims and other transactions, according to the agency.
January 22, 2004
State x-ray quality assurance program yields dividends
By Erik L. Ridley
A New Jersey state x-ray quality assurance program has yielded improved image quality and lower radiation doses, according to research from the New Jersey Department of Environmental Protection and the University of Utah Health Sciences Center in Salt Lake City.
January 22, 2004
2004 01 16 16 36 14 706
Schering gets European OK for Zevalin for NHL
By AuntMinnie.com staff writers
German pharmaceutical company Schering has received European Commission marketing approval for its radioimmunotherapy product Zevalin (ibritumomab tiuxetan), according to the Berlin-based firm.
January 21, 2004
Cook gets clearance for new stent
By AuntMinnie.com staff writers
Interventional device provider Cook has received Food and Drug Administration clearance for its Zilver 518 biliary stent.
January 19, 2004
Teleradiology firms obtaining own JCAHO accreditation
By Tracie L. Thompson
Providers of teleradiology services are now seeking accreditation from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), in hopes that they’ll get more business by reducing the credentialing and privileging burdens of clients who use their services.
January 19, 2004
Fuji gets FDA nod for FFDM printing
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received Food and Drug Administration 510(k) clearance to deploy its DryPix dry laser imagers for full-field digital mammography (FFDM) use.
January 14, 2004
Varian gets FDA nod for Trilogy
By AuntMinnie.com staff writers
January 8, 2004
Varian gets 510(k) for 3-D
By AuntMinnie.com staff writers
Varian Medical Systems has received U.S. Food and Drug Administration 510(k) marketing clearance for its 3-D cone-beam CT imaging system on a radiation therapy simulation and verification device.
January 7, 2004
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