Regulatory: Page 128

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
2012 10 18 09 23 06 449 Vu Comp Mass Mark 70
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
Societies endorse rules on access to CT settings
By AuntMinnie.com staff writers
Several medical imaging societies have applauded the publication of the National Electrical Manufacturers Association's new CT access rules, which aim to limit and strictly define which employees can change CT equipment settings.
October 10, 2012
Volcano gets FDA, CE Mark OK for IVUS catheter
By AuntMinnie.com staff writers
Intravascular ultrasound developer Volcano announced that it has received both the CE Mark and 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new Visions PV.035 digital intravascular ultrasound imaging (IVUS) catheter.
October 8, 2012
HIMSS responds to GOP letter on stage 2 meaningful use
By AuntMinnie.com staff writers
The Healthcare Information and Management Systems Society (HIMSS) has responded to a letter from Republican leaders of the U.S. House of Representatives criticizing the U.S. Department of Health and Human Services about the way it is implementing the Health Information Technology for Economic and Clinical Health Act to incentivize healthcare providers to adopt electronic recordkeeping.
October 7, 2012
GOP House leaders criticize, ask for halt to stage 2 MU
By Cynthia E. Keen
Republican leaders of the congressional committees in the U.S. House of Representatives overseeing health issues criticized the U.S. Department of Health and Human Services about stage 2 meaningful use (MU) criteria for the adoption of electronic records, and asked that incentive payments be suspended.
October 4, 2012
Election 2012: What's at stake for radiology
By Kate Madden Yee
The upcoming U.S. elections in November will significantly affect the practice of radiology, and radiologists need to understand what's at stake, according to an article published in the October issue of the Journal of the American College of Radiology.
October 3, 2012
2012 10 03 14 43 34 235 Election Flag Box 70
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