Regulatory: Page 269

Medtronic receives FDA OK for stent clinical trial
By AuntMinnie.com staff writers
Medical device manufacturer Medtronic has received FDA clearance to begin the third round of clinical trials on its drug-eluting coronary stent Endeavor.
February 11, 2004
Agenix readies IND application for ThromboView
By AuntMinnie.com staff writers
Australian pharmaceutical developer Agenix is preparing to submit an investigational new drug (IND) application for its ThromboView radiopharmaceutical to the Food and Drug Administration in the second quarter.
February 11, 2004
Midway mark for mid-winter SalaryScan
By Brian Casey
There’s just a few weeks left to participate in the survey, which will enable AuntMinnie to update the data in our popular SalaryScan compensation analysis tool.
February 10, 2004
Nucletron gets 510(k) for Simulix Evolution
By AuntMinnie.com staff writers
Radiotherapy provider Nucletron has received Food and Drug Administration 510(k) marketing clearance for its Simulix Evolution digital simulator.
February 9, 2004
Rubicon completes European enrollment
By AuntMinnie.com staff writers
Interventional device developer Rubicon Medical has completed enrollment for clinical testing of its Rubicon Filter in Europe, according to the Salt Lake City-based firm.
February 4, 2004
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
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