Regulatory: Page 130

U-Systems lands final clearance for somo.v for dense breasts
By Erik L. Ridley
Automated breast ultrasound technology developer U-Systems has become the first vendor to receive U.S. Food and Drug Administration clearance to market a device specifically for use in screening women with dense breasts.
September 17, 2012
FDA clears Aycan's iPad telerad app
By AuntMinnie.com staff writers
Radiology informatics firm Aycan Medical Systems has received 510(k) clearance for its Apple iPad app for teleradiology from the U.S. Food and Drug Administration.
September 17, 2012
'Sequestration' could cause $11.1B in Medicare pay cuts
By AuntMinnie.com staff writers
The automatic budget cuts required under the "sequestration" deficit reduction law passed earlier this year could result in up to $11.1 billion in cuts to Medicare unless the law is overridden, according to a report issued by the U.S. Office of Management and Budget.
September 16, 2012
NOPR asks CMS to ease coverage rules for PET
By AuntMinnie.com staff writers
The National Oncologic PET Registry (NOPR) is asking the U.S. Centers for Medicare and Medicaid Services (CMS) to make reimbursement for oncology PET studies easier by ending its requirement that payments be made under its coverage with evidence development (CED) statute.
September 16, 2012
Medical imaging advocacy groups head to Congress
By AuntMinnie.com staff writers
Medical imaging advocacy groups and patients who have benefited from diagnostic imaging will be on Capitol Hill on September 20 to protest proposed reimbursement cuts for medical imaging services.
September 13, 2012
LifeImage completes 1st FDA inspection
By AuntMinnie.com staff writers
Medical image sharing firm LifeImage announced that the U.S. Food and Drug Administration (FDA) completed its first inspection of the company's headquarters and conducted an examination of the company's quality management system.
September 12, 2012
FDA clears C-11 choline PET for prostate cancer
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has approved the production and use of PET radiopharmaceutical carbon-11 (C-11) choline injection to detect recurrent prostate cancer, the agency announced.
September 11, 2012
Navidea fails to get clearance for Lymphoseek
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has elected not to approve radiopharmaceutical developer Navidea Biopharmaceuticals' new drug application for its Lymphoseek radiopharmaceutical.
September 10, 2012
A rocky road awaits radiologists during Obamacare rollout
By James Brice
SAN FRANCISCO - Higher taxes, lower reimbursement, and more federal control over the use of advanced imaging in clinical practice. Dr. Frank J. Lexa used these terms to describe a dark vision of radiology after healthcare reform at the 2012 California Radiological Society annual meeting.
September 10, 2012
2012 09 11 10 27 32 236 Frank Lexa 70
UPMC, staffing agencies sued in Kwiatkowski case
By AuntMinnie.com staff writers
UPMC health system and two medical staffing agencies have been sued by a Kansas woman who claims she was infected with hepatitis C because the defendants failed to notify authorities that traveling radiologic technologist David Kwiatkowski had been fired in 2008 for allegedly stealing drugs from the hospital.
September 9, 2012
FDA calls out Lilly on Amyvid images
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration is admonishing Eli Lilly for posting what it called "misleading" multicolored images on its website illustrating results with the PET radiopharmaceutical Amyvid (florbetapir F-18 injection).
September 9, 2012
ASTRO asks CMS to halt planned payment cuts
By AuntMinnie.com staff writers
A letter to the U.S. Centers for Medicare and Medicaid Services (CMS) is the American Society for Radiation Oncology's (ASTRO) latest push in its campaign to stop proposed payment cuts of nearly $300 million scheduled to begin next near.
September 9, 2012
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