Regulatory: Page 194

Shina gets nod for AV software
By AuntMinnie.com staff writers
Software developer Shina Systems has received U.S. Food and Drug Administration 510(k) clearance for its 3Di 3D/4D advanced visualization software.
February 2, 2010
SNM summit advances molecular imaging
By AuntMinnie.com staff writers
Advisors from the U.S. Food and Drug Administration provided a regulatory framework for developing nanotechnology and targeted radiopharmaceuticals at this week's SNM Nanomedicine and Molecular Imaging Summit.
February 1, 2010
FDA budget for FY 2011 to rise 23%
By AuntMinnie.com staff writers
The Obama administration is proposing to increase funding for the U.S. Food and Drug Administration by 23% in fiscal 2011 as part of the agency's effort to "transform" the way it regulates food and medical products.
February 1, 2010
CMS taps three for accreditation
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has chosen the American College of Radiology, the Intersocietal Accreditation Commission, and the Joint Commission to accredit suppliers furnishing the technical component of advanced imaging procedures.
January 28, 2010
FDA clears Fuji's AcSelerate DR
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received 510(k) clearance from the U.S. Food and Drug Administration for its Fuji Digital Radiography (FDR) AcSelerate system.
January 26, 2010
GE, Bracco receive FDA violation notices
By AuntMinnie.com staff writers
GE Healthcare and Bracco have both received notices of violation from the U.S. Food and Drug Administration for marketing claims related to their Visipaque and Isovue x-ray contrast agents.
January 24, 2010
U.S. senator probes hospitals about healthcare IT issues
By Cynthia E. Keen
A U.S. senator has sent a letter to 31 hospitals requesting feedback about problems with their healthcare IT systems and asking them to report reticence or failure by healthcare IT vendors to promptly fix problems with HIT software.
January 24, 2010
FDA meeting to review 510(k) device process
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has scheduled a meeting in February to review its 510(k) premarket notification process for reviewing and clearing medical devices.
January 21, 2010
Court dismisses ACC suit against Medicare
By AuntMinnie.com staff writers
A federal court in Florida has dismissed a lawsuit filed by the American College of Cardiology (ACC) over proposed Medicare cuts, ruling that it did not have authority to review Medicare payment decisions.
January 18, 2010
Healthcare bill likely to require mammo coverage
By AuntMinnie.com staff writers
Final healthcare reform legislation is likely to require coverage for more mammograms than controversial new guidelines after radiologists, imaging equipment makers, and women's groups stepped up pressure on lawmakers.
January 18, 2010
VA responds to NRC report on brachytherapy violations
By Cynthia E. Keen
The U.S. Department of Veterans Affairs has responded to a report issued by the U.S. Nuclear Regulatory Commission (NRC) on treatment errors in the prostate cancer brachytherapy program at the Philadelphia Veterans Affairs Medical Center (VAMC) between 2002 and 2008.
January 17, 2010
InSightec gets Japanese clearance
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec said that its ExAblate MR-guided focused ultrasound system has received clearance from Japan's Ministry of Health, Labor, and Welfare for the treatment of women with uterine fibroids.
January 12, 2010
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