Regulatory: Page 127

FDA issues emergency guidance for breast centers
By AuntMinnie.com staff writers
In the wake of Hurricane Sandy, the U.S. Food and Drug Administration has issued a guidance document for mammography facilities affected by natural disasters.
November 4, 2012
Indian Health Service issues PHR notice
By AuntMinnie.com staff writers
The U.S. Indian Health Service intends to implement a Web-based personal health record (PHR) system, enabling its patients to access portions of their medical records electronically.
November 4, 2012
ASTRO commends CMS for reducing RT cuts
By AuntMinnie.com staff writers
The American Society for Radiation Oncology (ASTRO) issued a comment on Friday commending the U.S. Centers for Medicare and Medicaid Services (CMS) for issuing a final rule on reimbursement payment policies for radiation therapy (RT).
November 1, 2012
No good news for imaging in proposed 2013 Medicare rates
By Kate Madden Yee
There isn't much to like for medical imaging in new Medicare payment rates for 2013. In a November 1 announcement, the U.S. Centers for Medicare and Medicaid Services revealed the size of the looming payment cut under the sustainable growth rate formula, and also affirmed a raft of other payment cuts that will affect radiology.
November 1, 2012
Accuray gets FDA OK for CyberKnife M6
By AuntMinnie.com staff writers
Radiation oncology firm Accuray has received 510(k) clearance from the U.S. Food and Drug Administration for its new CyberKnife M6 series.
October 31, 2012
CMS meeting to review PET amyloid coverage
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) will convene an advisory committee meeting in January 2013 to review its policies regarding coverage of PET imaging studies of beta amyloid in the brain.
October 31, 2012
GAO attacks imaging self-referral, requests pay cut for exams
By Brian Casey
A new report from the U.S. Government Accountability Office (GAO) takes a hard line on physician self-referral of imaging services, detailing more than $100 million in annual unnecessary spending in CT and MRI alone. The report recommends steps to curb the practice, including a pay cut for self-referred imaging studies.
October 31, 2012
Navidea tries again with Lymphoseek NDA
By AuntMinnie.com staff writers
Radiopharmaceutical developer Navidea Biopharmaceuticals has resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration for its Lymphoseek radiopharmaceutical.
October 30, 2012
Carestream gets FDA nod for lesion software
By AuntMinnie.com staff writers
Carestream Health has received clearance from the U.S. Food and Drug Administration for a module that enables lesion management tools to be used on its Vue PACS workstation software.
October 29, 2012
3D imaging software from ORS gets CE Mark
By AuntMinnie.com staff writers
Advanced visualization software developer Object Research Systems (ORS) announced that its ORS Visual 3D medical imaging software has received the CE Mark in Europe.
October 25, 2012
One-fourth of Congress opposes RT cuts
By AuntMinnie.com staff writers
More than 130 members of Congress, both Democrats and Republicans, have signed letters sent to the U.S. Centers for Medicare and Medicaid Services opposing the agency's proposed reimbursement reductions for radiation therapy (RT) that would be implemented in 2013.
October 24, 2012
CIVCO nets FDA OK for Protura
By AuntMinnie.com staff writers
Ultrasound and radiotherapy products developer CIVCO Medical Solutions has received 510(k) clearance from the U.S. Food and Drug Administration for the integration of its Protura robotic patient positioning system with radiation oncology firm Elekta's motion management interface.
October 24, 2012
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