Regulatory: Page 75

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
Calgary Scientific brings ResolutionMD to Singapore
By AuntMinnie.com staff writers
Calgary Scientific said that its ResolutionMD enterprise image viewing software has been registered with the Singapore Health Sciences Authority.
August 12, 2015
Senate bill seeks to protect mammo screening
By AuntMinnie.com staff writers
U.S. Sen. Barbara Mikulski (D-MD) has introduced bipartisan legislation to protect free annual mammogram screenings for women ages 40 and older.
August 9, 2015
VA approves use of Siemens' software
By AuntMinnie.com staff writers
The U.S. Department of Veterans Affairs (VA) has approved Siemens Healthcare's syngo Dynamics cardiovascular imaging software for use with its VistA Imaging PACS after successful validation testing.
August 6, 2015
FDA clears new Samsung DR system
By AuntMinnie.com staff writers
Samsung Electronics America has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its GC85A digital radiography (DR) unit.
August 5, 2015
ASTRO hails fight on radiation oncology Medicare cuts
By AuntMinnie.com staff writers
The American Society for Radiation Oncology (ASTRO) is applauding two U.S. senators for their effort to lobby against radiation oncology payment reductions included in the 2016 Medicare Physician Fee Schedule.
August 5, 2015
Merit expands QuadraSphere indications
By AuntMinnie.com staff writers
Disposable products developer Merit Medical Systems has received U.S. Food and Drug Administration 510(k) clearance for a new indication for its QuadraSphere therapeutic microspheres.
August 5, 2015
Elekta gets FDA nod for Gamma Knife Icon
By AuntMinnie.com staff writers
Radiation oncology firm Elekta has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its Leksell Gamma Knife Icon intracranial radiosurgery system.
August 4, 2015
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