Regulatory: Page 108

Philips gets FDA clearance for breast density measurement tool
By AuntMinnie.com staff writers
Philips Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration for a spectral breast density measurement application for its MicroDose SI full-field digital mammography system.
December 19, 2013
Siemens gets FDA OK for Prisma MRI scanner
By AuntMinnie.com staff writers
Siemens Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration for its Magnetom Prisma 3-tesla MRI scanner.
December 18, 2013
Senate passes budget -- and SGR patch
By AuntMinnie.com staff writers
The U.S. Senate has passed the Bipartisan Budget Act of 2013, which includes a three-month reprieve of cuts to physician payment rates that would have gone into effect on January 1.
December 17, 2013
ACR praises new House imaging utilization bill
By AuntMinnie.com staff writers
The American College of Radiology (ACR) said it strongly supports the proposed Excellence in Diagnostic Imaging Utilization Act of 2013.
December 17, 2013
Navidea files supplemental NDA for Lymphoseek
By AuntMinnie.com staff writers
Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration.
December 16, 2013
FDA: Nipple aspirate test can't replace mammogram
By AuntMinnie.com staff writers
The nipple aspirate test is not a substitute for a mammogram, according to the U.S. Food and Drug Administration.
December 12, 2013
Congress hustles to address SGR problem before end of year
By Kate Madden Yee
Legislative action to address the problematic sustainable growth rate (SGR) formula has heated up recently. On Wednesday, December 11, the House added a three-month SGR patch to its version of the budget bill, and on Thursday, House and Senate committees advanced bills that would replace the SGR altogether.
December 12, 2013
Discrepancies trigger Ontario radiology peer-review program
By Rosemary Frei
Formal radiology peer review will be implemented across the province of Ontario after an 18.2% discrepancy rate was uncovered in an external review of images read by Ontario radiologist Dr. Ivo Slezic. The review's findings were released last week by Trillium Health Partners.
December 10, 2013
SGR fix in the works as CBO again cuts price tag
By Kate Madden Yee
The Congressional Budget Office (CBO) announced it has again cut its estimate for repealing the sustainable growth rate (SGR). The updated forecast may make it easier for Congress to pass SGR repeal legislation before it adjourns for the year on December 13.
December 9, 2013
C4 Imaging nets 510(k) clearance for MRI marker
By AuntMinnie.com staff writers
C4 Imaging has received U.S. Food and Drug Administration 510(k) clearance for its Sirius MRI marker.
December 8, 2013
OR Technology gets FDA OK
By AuntMinnie.com staff writers
PACS and image processing firm OR Technology has received good news from the U.S. Food and Drug Administration.
December 5, 2013
GOP senators: Don't nix in-office exception in Stark law
By AuntMinnie.com staff writers
Four Republican U.S. senators have sent a letter urging Senate leadership to preserve the in-office ancillary services exception to the Stark law.
December 3, 2013
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