Regulatory: Page 179

Neoprobe wraps up pre-NDA meeting
By AuntMinnie.com staff writers
Gamma camera probe developer Neoprobe said it has completed a pre-new drug application (NDA) assessment with the U.S. Food and Drug Administration for its Lymphoseek radiopharmaceutical agent.
October 6, 2010
European MRI advocates gain victory on EMF Directive
By Leo Cendrowicz
A controversial European Union law that potentially could threaten the use of MRI in research laboratories and medical clinics will be overhauled, clearing the way for the technology to continue being used across Europe, according to an accord announced last week by EU officials.
October 4, 2010
2010 10 04 08 59 32 902 Euro Mri Directive 250
Norwegian researcher launches DBT study
By AuntMinnie.com staff writers
A Norwegian researcher has launched a study that will compare the performance of digital breast tomosynthesis (DBT) to conventional digital mammography, according to a Norwegian hospital.
October 3, 2010
DFine gets FDA nod for RFA device
By AuntMinnie.com staff writers
Medical device developer DFine has received U.S. Food and Drug Administration 510(k) clearance for a percutaneous radiofrequency ablation (RFA) device.
October 3, 2010
IOM initiates HIT patient safety study
By AuntMinnie.com staff writers
The U.S. Office of the National Coordinator for Health Information Technology announced a $989,000 contract with the Institute of Medicine (IOM) to conduct a 12-month study to ensure that health IT will achieve its full potential for improving patient safety in healthcare.
October 3, 2010
Calif. governor signs medical radiation bill into law
By Eric Barnes
Gov. Arnold Schwarzenegger of California on Wednesday signed a medical radiation protection bill into law, paving the way for implementation of the first state law in the U.S. aimed at protecting patients from excessive radiation exposure received during CT scans and radiation therapy procedures.
September 29, 2010
ONC clarifies 'meaningful use' certification rules
By Cynthia E. Keen
"Meaningful use" has become the holy grail of healthcare IT -- the standard that providers must achieve to receive stimulus funds. U.S. regulators recently issued final rules that define how they view meaningful use, but the guidelines raise almost as many questions as they answer.
September 29, 2010
ACR unveils CT accreditation program
By AuntMinnie.com staff writers
A new streamlined CT accreditation program from the American College of Radiology (ACR) will cut the time required for CT scanning facilities to get accredited "in half," according to the organization.
September 27, 2010
RBMA: Matching accreditation programs to your facility
By Kate Madden Yee
The deadline is getting closer: Providers of advanced imaging services who bill for technical components must become accredited by January 1, 2012. The U.S. Centers for Medicare and Medicaid Services has designated three organizations as accrediting bodies. Which program is best for your facility?
September 27, 2010
Parascript gets CE Mark
By AuntMinnie.com staff writers
Computer-aided detection (CAD) firm Parascript has received the European CE Mark for its AccuDetect Galileo mammography CAD software.
September 26, 2010
FDA panel gives nod to Hologic tomosynthesis PMA
September 23, 2010
FDA panel gives nod to Hologic tomosynthesis PMA
By AuntMinnie.com staff writers
An advisory panel of the U.S. Food and Drug Administration has unanimously approved a premarket approval (PMA) application from Hologic for a digital breast tomosynthesis (DBT) system. If the FDA signs off on the final PMA, Hologic will be the first vendor to sell a DBT system on the U.S. market.
September 23, 2010
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