Regulatory: Page 203

FDA OKs new UltraSPECT feature
By AuntMinnie.com staff writers
Nuclear medicine firm UltraSPECT has added a U.S. Food and Drug Administration-cleared half-dose imaging feature to its Xpress.Cardiac half-time wide-beam reconstruction (WBR) image reconstruction product.
June 7, 2009
TomTec wins FDA OK for 2D cardiac software
By AuntMinnie.com staff writers
Imaging software developer TomTec Imaging Systems has received clearance from the U.S. Food and Drug Administration for its 2D Cardiac Performance Analysis software.
June 3, 2009
FDA OKs Brit PACS upgrade
By AuntMinnie.com staff writers
RIS/PACS vendor Brit Systems has received 510(k) clearance from the U.S. Food and Drug Administration for an upgrade of its browser-based PACS software.
June 2, 2009
FDA gives GE's DaTscan priority review
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has accepted GE Healthcare's new drug application for DaTscan (ioflupane iodine-123 injection) for priority review.
June 2, 2009
UltraSPECT nets FDA OK for software
By AuntMinnie.com staff writers
Nuclear medicine firm UltraSPECT has received clearance from the U.S. Food and Drug Administration for its attenuation correction/scatter correction (ACSC) software package.
June 1, 2009
Prowess gets FDA nod for RT software
By AuntMinnie.com staff writers
Radiation therapy firm Prowess has received U.S. Food and Drug Administration clearance for its RealART real-time adaptive radiation therapy software.
June 1, 2009
FDA clears Boston Scientific catheter
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received clearance from the U.S. Food and Drug Administration for a catheter used for endoscopic procedures, the company said.
May 27, 2009
Carestream ready to market DryView 5850
By AuntMinnie.com staff writers
Carestream Health has received U.S. Food and Drug Administration clearance for its DryView 5850 laser imager.
May 26, 2009
Pie software gets FDA nod
By AuntMinnie.com staff writers
Imaging firm Pie Medical Imaging has received U.S. Food and Drug Administration clearance for its CAAS MR Flow software.
May 26, 2009
iCAD submits VeraLook data to FDA
By AuntMinnie.com staff writers
Computer-aided detection (CAD) firm iCAD has submitted data to the U.S. Food and Drug Administration for 510(k) clearance of its VeraLook CAD technology for CT colonography.
May 26, 2009
DR Systems gets Canadian OK
By AuntMinnie.com staff writers
PACS software developer DR Systems has received regulatory approval in Canada to sell its Unity RIS/PACS software.
May 17, 2009
PDS wins clearance for NeuroPET scanner
By AuntMinnie.com staff writers
PhotoDetection Systems (PDS) has received approval from the U.S. Food and Drug Administration for its NeuroPET scanner.
May 14, 2009
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