Regulatory: Page 204

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
FDA OKs Siemens' 16-slice PET/CT
By AuntMinnie.com staff writers
Siemens Healthcare has received clearance from the U.S. Food and Drug Administration for its Biograph TruePoint 16-slice PET/CT system.
May 7, 2009
IsoRay expands into Canadian market
By AuntMinnie.com staff writers
Medical isotope developer IsoRay Medical has received approval to market its brachytherapy seeds in Canada.
May 6, 2009
Medtronic progresses with Endurant trial
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has completed enrollment in an investigational device exemption study of its Endurant abdominal aortic stent graft.
May 5, 2009
FDA clears GE's OEC C-arm
By AuntMinnie.com staff writers
GE Healthcare has received approval from the U.S. Food and Drug Administration to market its OEC 9900 Elite C-arm cardiac and vascular systems.
May 4, 2009
Hologic posts large loss in Q2, delays tomo review
By AuntMinnie.com staff writers
Write-downs largely related to its acquisition of Cytyc led to a $2.3 billion net loss for women's imaging vendor Hologic in its fiscal second quarter.
May 4, 2009
DraxImage gets FDA nod for generic sestamibi
By AuntMinnie.com staff writers
Canadian radiopharmaceutical firm DraxImage has received U.S. Food and Drug Administration approval for its generic sestamibi offering.
May 3, 2009
IMRIS wins CE Mark for MR angiography suite
By AuntMinnie.com staff writers
Canadian intraoperative MRI technology developer IMRIS has received the CE Mark for its MR imaging and x-ray angiography suite.
April 30, 2009
Positron gets FDA nod for cardiac PET scanner
By AuntMinnie.com staff writers
Cardiac molecular imaging company Positron has received U.S. Food and Drug Administration approval for a new PET scanner product line.
April 30, 2009
FDA clears proton positioning system
By AuntMinnie.com staff writers
Radiopharmaceutical firm Ion Beam Applications and partner ProCure Treatment Centers have announced that the U.S. Food and Drug Administration has cleared a patient positioning system for proton therapy systems marketed by the companies.
April 28, 2009
RaySearch, Philips launch SmartArc
By AuntMinnie.com staff writers
Swedish radiation therapy software developer RaySearch Laboratories said that partner Philips Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its SmartArc treatment planning software.
April 21, 2009
iCAD wins FDA nod for breast MRI software
By AuntMinnie.com staff writers
Computer-aided detection (CAD) firm iCAD has received clearance from the U.S. Food and Drug Administration for its interventional planning package for breast MRI.
April 15, 2009
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