Regulatory: Page 205

FDA OKs Virtual Radiologic PACS product
By AuntMinnie.com staff writers
Teleradiology services provider Virtual Radiologic has received U.S. Food and Drug Administration clearance for its vRad PACS.
April 12, 2009
Xoft receives Canadian approval for Axxent
By AuntMinnie.com staff writers
Brachytherapy device developer Xoft has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell its Axxent electronic brachytherapy system.
April 8, 2009
FDA clears Ziosoft cardiac software
By AuntMinnie.com staff writers
Advanced visualization software developer Ziosoft has received U.S. Food and Drug Administration clearance for two new cardiac analysis software applications, one for calcium scoring and the other for cardiac function analysis.
April 8, 2009
FDA OKs Carestream DRX-1
By AuntMinnie.com staff writers
Carestream Health has received clearance from the U.S. Food and Drug Administration for its Carestream DRX-1 system.
April 7, 2009
MURR plans NRC filing next year
By AuntMinnie.com staff writers
The University of Missouri Research Reactor (MURR) Center plans to file its license application with the Nuclear Regulatory Commission (NRC) next year, with expectations to supply the medical isotope molybdenum-99 within four years.
April 6, 2009
Aribex handheld x-ray device gets OK in Maryland
By AuntMinnie.com staff writers
Handheld x-ray developer Aribex announced that its Nomad system has been approved for use by dentists and veterinarians in the state of Maryland.
April 2, 2009
Medtronic brings Endeavor stent to Japan
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has received approval for its Endeavor drug-eluting coronary stent system by the Japanese Ministry of Health, Labour, and Welfare.
March 29, 2009
FDA clears Digirad's SPECT/CT device
By AuntMinnie.com staff writers
Nuclear medicine firm Digirad has received 510(k) clearance from the U.S. Food and Drug Administration to market its Cardius X-ACT imaging system.
March 25, 2009
Orbital Therapy nets FDA OK for breast table
By AuntMinnie.com staff writers
Orbital Therapy has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ClearVue prone position breast radiotherapy treatment table.
March 12, 2009
Sicel nets FDA OK for dosimeter
By AuntMinnie.com staff writers
Dosimetry developer Sicel Technologies has received clearance from the U.S. Food and Drug Administration to begin marketing its DVS-HFT wireless implantable dosimeter.
March 8, 2009
Bracco revisits plans for U.S. launch of SonoVue
By AuntMinnie.com staff writers
VIENNA - Italian contrast firm Bracco Imaging is reviving plans to launch its SonoVue contrast agent in the U.S. The Milan firm plans to sponsor a multicenter clinical trial this year to collect data for a regulatory submission to the U.S. Food and Drug Administration.
March 7, 2009
Canada clears Konica Minolta's Xpress CR upgrade
By AuntMinnie.com staff writers
Konica Minolta Medical Imaging USA has received word that Health Canada has cleared the Xpress CR digital mammography upgrade for sale in Canada.
March 4, 2009
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