Regulatory: Page 131

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
FDA panel gives nod to 2D synthetic mode for Hologic breast tomo
By Kate Madden Yee
A U.S. Food and Drug Administration panel voted 9 to 1 on October 24 to recommend approval for a new imaging mode on the Selenia Dimensions 3D digital breast tomosynthesis system from Hologic that creates synthesized 2D images from 3D data.
October 24, 2012
InSightec gets FDA nod for bone metastases
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has received clearance from the U.S. Food and Drug Administration for its ExAblate MRI-guided focused-ultrasound system to treat pain from bone metastases in patients who do not respond to or cannot undergo radiation therapy.
October 21, 2012
EU's CHMP offers positive opinion on Amyvid
By AuntMinnie.com staff writers
Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Amyvid (florebetapir F-18) for injection as a PET radiotracer to detect beta-amyloid neuritic plaque in patients with cognitive impairment, according to Eli Lilly and its subsidiary Avid Radiopharmaceuticals.
October 18, 2012
VuCOMP secures PMA for digital mammography CAD
By Kate Madden Yee
Some things are worth the wait, believes computer-aided detection (CAD) developer VuCOMP about its newly approved CAD. The company has received premarket approval (PMA) notification for its M-Vu CAD software for digital mammography.
October 17, 2012
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NEC gets FDA nod for mammo monitor
By AuntMinnie.com staff writers
NEC Display Solutions of America has received 510(k) clearance from the U.S. Food and Drug Administration for its 21.3-inch MultiSync MD211G3 medical display for the viewing of digital mammography images.
October 15, 2012
ONC recruits members for workgroups
By AuntMinnie.com staff writers
The U.S. Office of the National Coordinator for Health IT (ONC) is recruiting new members to participate in its health IT policy and standards committees.
October 14, 2012
OIG confirms lack of encryption on VA computers
By AuntMinnie.com staff writers
An audit conducted by the Office of Inspector General (OIG) of the U.S. Department of Veterans Affairs (VA) has confirmed that only 16% of encryption software licenses purchased between 2006 and 2011 have been installed on the department's computers.
October 10, 2012
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