Regulatory: Page 121

MITA holds meetings with Brazilian regulatory agency
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) conducted a series of meetings earlier this month with industry partners in Brazil to explore opportunities to harmonize international medical device standards and expand market access to MITA member companies in Brazil and Latin America.
February 24, 2013
Bayer's radium-223 gets FDA priority review
By AuntMinnie.com staff writers
Bayer HealthCare's new drug application for its radium-223 dichloride investigational oncology compound will receive priority review by the U.S. Food and Drug Administration.
February 19, 2013
FDA OKs Medtronic pacemaker for MRI
By AuntMinnie.com staff writers
Interventional device developer Medtronic has received 510(k) clearance from the U.S. Food and Drug Administration for its Advisa MRI SureScan pacemaker.
February 14, 2013
Manufacturers make $97M medical device tax payment
By AuntMinnie.com staff writers
Medical imaging, radiation therapy, and other medical device manufacturers have made the second semimonthly payment of approximately $97 million to the U.S. Internal Revenue Service for the medical device excise tax.
February 14, 2013
FDA panel OK's NDA for Guerbet's Dotarem
By AuntMinnie.com staff writers
Guerbet has received a unanimous recommendation from the U.S. Food and Drug Administration's Medical Imaging Drugs Advisory Committee that the agency approve the company's new drug application (NDA) for MRI contrast agent Dotarem for use in adults and children 2 years and older.
February 14, 2013
Fluke nets FDA OK for safety device
By AuntMinnie.com staff writers
Test measurement firm Fluke Biomedical has received 510(k) clearance from the U.S. Food and Drug Administration for its automated, multifunctional ESA615 electrical safety analyzer.
February 13, 2013
FDA clears I3's ImageQube mammo module
By AuntMinnie.com staff writers
PACS vendor Intuitive Imaging Informatics (I3) has received clearance from the U.S. Food and Drug Administration for a mammography module of its ImageQube Web-based PACS software.
February 12, 2013
FDA approves new Definity manufacturing site
By AuntMinnie.com staff writers
Diagnostic imaging agent developer Lantheus Medical Imaging has received approval from the U.S. Food and Drug Administration for Jubilant HollisterStier to be a new manufacturing site for its Definity ultrasound contrast imaging agent .
February 10, 2013
Planmed gets FDA clearance for extremity CT scanner
By AuntMinnie.com staff writers
Finnish imaging vendor Planmed said it has received U.S. Food and Drug Administration clearance for its Verity extremity scanner.
February 10, 2013
Kids get their own EHR format
By AuntMinnie.com staff writers
Pediatric patients are now getting their own electronic health record (EHR) format with children-specific data elements, thanks to a new initiative from the U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality and the Centers for Medicare and Medicaid Services.
February 7, 2013
2nd bill to replace device tax is introduced
By AuntMinnie.com staff writers
A second bill to repeal the 2.3% medical device tax has been introduced into Congress.
February 7, 2013
SGR repeal bill debuts in House
By AuntMinnie.com staff writers
Legislation that would permanently repeal Medicare's sustainable growth rate (SGR) formula has been introduced in the U.S. House of Representatives by Rep. Allyson Schwartz (D-PA) and Rep. Joe Heck (R-NV).
February 6, 2013
Previous Page
Page 121 of 302
Next Page