Regulatory: Page 75

FDA OKs Medtronic's implantable heart device for MRI
By AuntMinnie.com staff writers
Medtronic has received U.S. Food and Drug Administration (FDA) approval for an implantable cardioverter defibrillator system for use with MRI scanners.
September 13, 2015
DEA removes GE compound as controlled substance
By AuntMinnie.com staff writers
The U.S. Drug Enforcement Administration (DEA) has removed a compound found in GE Healthcare's DaTscan SPECT radiopharmaceutical from the schedules of the Controlled Substances Act, which means the imaging agent will be more widely available to the medical community.
September 13, 2015
Delphinus wins $39.5M in venture capital
By AuntMinnie.com staff writers
Tomographic ultrasound developer Delphinus Medical Technologies has received $39.5 million in venture capital funding.
September 9, 2015
Philips gets FDA nod for spectral CT software
By AuntMinnie.com staff writers
Philips Healthcare has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Spectral Diagnostic Suite, a software suite of advanced visualization and analysis tools available for its IQon spectral CT scanner.
September 8, 2015
U.S. NRC starts review of LNT radiation theory
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission (NRC) is reviewing the linear no-threshold (LNT) model of the health effects of radiation and the idea that LNT should be replaced with a radiation hormesis model.
September 7, 2015
Surefire gets FDA nod for drug delivery device
By AuntMinnie.com staff writers
Interventional radiology technology developer Surefire Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Surefire Precision, a new infusion drug delivery device.
August 31, 2015
FDA clears Eizo monitor for breast tomo
By AuntMinnie.com staff writers
Display manufacturer Eizo has received U.S. Food and Drug Administration (FDA) 510(k) clearance for breast tomosynthesis applications on its RadiForce GX540 5-megapixel monochrome LCD monitor.
August 31, 2015
HealthMyne gets FDA nod for informatics software
By AuntMinnie.com staff writers
Imaging analytics start-up HealthMyne has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its platform of imaging informatics software.
August 24, 2015
Boston Scientific gets CE Mark for MRI-ready defibrillators
By AuntMinnie.com staff writers
Interventional and ultrasound technology developer Boston Scientific has received the CE Mark for MRI-conditional labeling for cardioverter defibrillators.
August 24, 2015
FDA readies new safety probe into gadolinium contrast
By Wayne Forrest
Once again, the U.S. Food and Drug Administration (FDA) is set to embark on an investigation into the safety of gadolinium-based contrast agents, after several recent studies found gadolinium deposits in the brains of some patients years after they had received contrast-enhanced MRI scans.
August 24, 2015
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St. Jude obtains CE Mark for MRI chronic pain unit
By AuntMinnie.com staff writers
St. Jude Medical has received the CE Mark for MRI-conditional labeling for its Prodigy MRI chronic pain unit with select leads.
August 23, 2015
FDA clears GE CT scanners for lung cancer screening
By AuntMinnie.com staff writers
Several GE Healthcare CT scanners have been cleared by the U.S. Food and Drug Administration (FDA) to perform low-dose lung cancer screening.
August 16, 2015
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