Regulatory: Page 108

Nucletron wins FDA clearance for Esteya
By AuntMinnie.com staff writers
Elekta's Nucletron division has received clearance from the U.S. Food and Drug Administration for its Esteya electronic brachytherapy system.
October 1, 2013
FDA clears Konica Minolta AeroDR detector
By AuntMinnie.com staff writers
Konica Minolta Medical Imaging has received clearance from the U.S. Food and Drug Administration for its AeroDR 10 x 12-inch wireless flat-panel digital radiography (DR) detector.
October 1, 2013
Lilly 'disappointed' with CMS beta-amyloid PET decision
By AuntMinnie.com staff writers
Once again, drug developer Eli Lilly is expressing disappointment with a regulatory decision related to its Amyvid PET radiopharmaceutical for the detection of Alzheimer's disease.
September 30, 2013
MITA lukewarm on CMS' PET decision
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) cited progress in the U.S. Centers for Medicare and Medicaid Services' (CMS) final decision on beta-amyloid PET coverage; however, the organization said it was disappointed by the scope.
September 30, 2013
SuperSonic Imagine gets FDA clearance
By AuntMinnie.com staff writers
Ultrasound technology developer SuperSonic Imagine announced that its Aixplorer MultiWave ultrasound system has received U.S. Food and Drug Administration clearance for the quantification capabilities of its ShearWave elastography technology.
September 30, 2013
Repeal medical device excise tax, nearly 1,000 groups say
By AuntMinnie.com staff writers
Nearly 1,000 organizations have signed a letter requesting that the U.S. Congress repeal the medical device excise tax.
September 29, 2013
CMS upholds PET decision for dementia
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) is holding to its position restricting reimbursement for PET imaging for dementia or neurodegenerative disease.
September 26, 2013
Helium bill floats over final hurdle in Congress
By AuntMinnie.com staff writers
Legislation that would prevent the U.S. from going over a "helium cliff" cleared a final obstacle on September 26 and will go on to President Barack Obama for his signature.
September 26, 2013
FDA guidance on mobile apps offers clarity to developers
By Erik L. Ridley
The U.S. Food and Drug Administration's release on Monday of its long-awaited final guidance on mobile medical applications was designed to address market confusion over its policy for regulating these apps. While some questions remain, the guidance offers app developers a path forward in determining how to secure regulatory clearance for their products.
September 25, 2013
2012 05 24 14 25 16 915 Ipad Flower 250 20130509213653
IBA seeks FDA approval for proton therapy gantry system
By AuntMinnie.com staff writers
Radiopharmaceutical firm IBA Molecular has submitted documentation to the U.S. Food and Drug Administration for a compact proton therapy gantry.
September 23, 2013
Given's PillCam approved in Japan
By AuntMinnie.com staff writers
Video-capsule developer Given Imaging has been given the green light for its PillCam SB 3 system in Japan.
September 23, 2013
FDA mobile medical apps guidance includes radiology apps
By Erik L. Ridley
More than two years after it issued a draft proposal, the U.S. Food and Drug Administration on Monday released its final guidance on the regulation of mobile medical applications for developers. Radiology-oriented apps figure prominently in the examples of mobile apps the agency said it intends to regulate.
September 22, 2013
2013 09 06 11 46 32 375 Fda Logo 200
Previous Page
Page 108 of 302
Next Page