Regulatory: Page 201

IsoRay nets FDA OK on seeds
By AuntMinnie.com staff writers
Medical isotope developer IsoRay Medical has received additional U.S. Food and Drug Administration (FDA) 510(k) clearance for its Proxcelan cesium-131 brachytherapy seeds.
August 17, 2009
FDA's CDRH head steps down
By AuntMinnie.com staff writers
The director of the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) announced this week that he is stepping down.
August 12, 2009
FDA panel recommends GE's DaTSCAN
By AuntMinnie.com staff writers
GE Healthcare has cleared one more hurdle in its quest to bring a new brain SPECT radiopharmaceutical called DaTscan to market.
August 10, 2009
GE gets clearance for wide-bore MR scanner
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration clearance for Optima MR450w, a 70-cm 1.5-tesla MR scanner.
August 10, 2009
FDA panel to review GE DaTscan agent
By AuntMinnie.com staff writers
A U.S. Food and Drug Administration advisory panel will meet on August 11 to discuss GE Healthcare's new drug application for DaTscan (ioflupane iodine-123 injection).
August 9, 2009
FDA clears Time Medical's open MRI system
By AuntMinnie.com staff writers
MR firm Time Medical has received clearance from the U.S. Food and Drug Administration for its whole-body open MRI system.
August 5, 2009
NeuroLogica's CereTom gets Brazil OK
By AuntMinnie.com staff writers
Portable scanner developer NeuroLogica has received marketing clearance for its CereTom scanner from ANVISA, the National Health Surveillance Agency in Brazil.
August 4, 2009
FDA OKs Carestream DR system
By AuntMinnie.com staff writers
Carestream Health has received 510(k) clearance from the U.S. Food and Drug Administration for its Carestream DRX-Evolution.
August 4, 2009
Cerner ProVision gets FDA nod
By AuntMinnie.com staff writers
Healthcare information systems firm Cerner has received 510(k) clearance from the U.S. Food and Drug Administration for its ProVision mammography workstation.
August 3, 2009
HHS delegates HIPAA enforcement
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) has assigned authority for administering and enforcing the HIPAA Security Rule to its Office for Civil Rights.
August 3, 2009
FDA OKs Neusoft's NeuViz CT
By AuntMinnie.com staff writers
Neusoft Medical Systems has received U.S. Food and Drug Administration clearance for its NeuViz 16 multislice CT scanner.
July 23, 2009
Elekta nets FDA OK for VMAT
By AuntMinnie.com staff writers
Swedish oncology firm Elekta has received 510(k) clearance from the U.S. Food and Drug Administration for its volumetric modulated arc therapy (VMAT) for the Monaco treatment planning system.
July 23, 2009
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