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28 Feb 2012, 6:08 pm
Firms can’t simply choose to sell devices that FDA has found are not safe and effective,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. [read post]
4 Jun 2012, 4:51 pm
According to FDA Center for Devices and Radiological Health Director Jeffrey Shuren, the final guidance “clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations. [read post]
8 Aug 2012, 2:00 pm
This clinic was owned and operated by Radiology and Imaging Services Inc. [read post]
9 Dec 2015, 4:02 pm
., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. [read post]
13 May 2024, 2:49 pm
As a preliminary matter, it is worthwhile to highlight that this risk is captured in the Human-Centered core principle and, more broadly, 600-1 is properly viewed as part of the Governance core principle. [read post]
23 Mar 2014, 3:40 pm
” Even a poorly constructed radiological dispersion device—commonly but inaccurately known as a “dirty bomb”— could incite widespread panic and generate significant contamination. [read post]
7 Jul 2010, 11:36 am
two lawyers and Long Island Law firm engaged in a scheme to submit false or fraudulent claims for radiology services to GEICO associated with no-fault claims. [read post]
13 Dec 2011, 10:00 am
The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. [read post]
2 Jul 2008, 9:45 pm
Brenner, director of the Center for Radiological Research at Columbia University. [read post]
29 Sep 2011, 9:00 am
., chief pediatric medical officer at FDA's Center for Devices and Radiological Health. [read post]
23 Jun 2010, 1:14 pm
Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health, announced that the goal of the agency will be to overhaul its procedures to speed innovation while protecting patient safety. [read post]
22 Mar 2011, 12:00 pm
David Brenner, Phd,DSr, a researcher at The Center for Radiological Research at Columbia University in New York, reports that TSA's use of the machines will create an increase risk to passenger by causing an additional 100 cancers in the population each year. [read post]
13 Apr 2011, 7:29 am
“Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved," said the Senate subcommittee, adding that "the results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months. [read post]
17 Apr 2010, 8:33 am
Past Medical Expenses: City of Sacramento Fire Department $ 488.75 Medical Center $ 55,634.00 Paul Brown, M.D [read post]
17 Dec 2009, 12:40 pm
New laws impacting California health care providers include: Amendments to the 2008 law requiring certain health care providers to disclose unlawful and unauthorized uses or disclosure of medical information Laws requiring the Department of Public Health [www.cdph.ca.gov] to more timely process and approve applications for new or modified hospital outpatient services Provisions impacting the delivery of radiologic and diagnostic imaging services, such as permitting physician… [read post]
25 May 2012, 7:26 am
The Tennessee Division of Radiological Health is monitoring the situation closely. [read post]
3 Jun 2014, 8:18 am
HealthDay quoted William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, from a press release, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products. [read post]
1 Aug 2008, 12:16 pm
Leonard Berlin, chairman of the radiology department at Rush North Shore Medical Center in Skokie says he was not aware of this. [read post]
13 Dec 2011, 10:00 am
The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. [read post]
12 Mar 2012, 3:40 pm
" Scott Atlas, professor of radiology and chief of neuroradiology at the Stanford University Medical Center and senior fellow at the Hoover Institution, has an essay entitled "Striking 'Obamacare' a rejection of overreach. [read post]
