Regulatory: Page 124

Siemens gets FDA OK, will show products at ACC 2013
By AuntMinnie.com staff writers
Siemens Healthcare has received clearance from the U.S. Food and Drug Administration for its Artis Q and Artis Q.zen angiography system product lines.
March 6, 2013
HIMSS: Mobile devices raise thorny legal issues in healthcare
By Erik L. Ridley
NEW ORLEANS - The use of mobile devices in healthcare environments offers unique security challenges, and institutions must implement and -- most importantly -- enforce policies regarding their use to mitigate legal risk, according to a Wednesday presentation at the Healthcare Information and Management Systems Society (HIMSS) meeting.
March 6, 2013
FDA clears Philips' live image-guidance tool
By AuntMinnie.com staff writers
Royal Philips Electronics, parent company of Philips Healthcare, announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its EchoNavigator live image-guidance tool.
March 4, 2013
ACR backs bill to restore imaging access
By AuntMinnie.com staff writers
The American College of Radiology (ACR) is endorsing the Diagnostic Imaging Services Access Protection Act (HR 846), which would correct a 25% multiple procedure payment reduction to Medicare reimbursement for interpretation of advanced diagnostic imaging scans performed on the same patient, in the same session.
February 28, 2013
Philips gets FDA OK for MicroDose SI FFDM
By AuntMinnie.com staff writers
Philips Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration for its MicroDose SI full-field digital mammography (FFDM) system.
February 28, 2013
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
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