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1 Sep 2015, 9:30 pm by Natalie Punchak
They point out that the director of the FDA’s Center for Devices and Radiological Health cited little more than anecdotal evidence of patient harm during a congressional hearing on the FDA’s announcement. [read post]
28 Jun 2023, 2:31 pm by Kurt R. Karst
Baumhardt, Senior Medical Device Regulation Expert & Philip Won —The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions. [read post]
18 Oct 2012, 10:42 am by Lebowitz & Mzhen
She testified that she had been a LPN since 1978, and had worked at the Berkshire Center since 2005. [read post]
31 Dec 2019, 2:08 pm by Emily Burchfield, Guest Author
The medical center plans to appeal the verdict, according to a report from the Ventura County Star. [read post]
7 Dec 2018, 11:18 am by Emily L. Hussey and Sung Park
., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 501(k) program to advance the review of safety and effectiveness of medical devices, Nov. 26, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm. [read post]
17 Jun 2016, 5:30 am by Kori Shafer-Stack
From 2007 to 2013 for claims at 12 months of experience, we observed little change on average in the number of visits for major radiology services by nonhospital providers. [read post]
18 Apr 2018, 6:55 pm by Yetunde Oni and Jennifer Pike
Integrate the Center for Devices and Radiological Health’s (CDRH) pre-market and post-market offices and activities to advance the use of a TPLC approach to device safety. [read post]
27 Jun 2011, 8:41 pm
Although the study results and recommendations are several months away, electronic record-keeping remains front and center. [read post]
13 Mar 2012, 10:06 am by Michael H. Cohen
“FDA’s concern is that the unexpected release of any part of this battery-powered toothbrush during use poses a risk of injury,” says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health. [read post]
16 Sep 2018, 9:05 pm by Guest Contributor
  As a patient of two urgent care centers, two emergency rooms, one hospital, and after interacting with the dozens of attending physicians, residents, nurses, and technicians in general practice, internal medicine, surgery, gastroenterology, radiology, the laboratory, and more — not one of these professionals questioned if foodborne illness could be the cause. [read post]
10 Nov 2009, 8:49 am
What might a PET scan (a radiological tool) reveal about the failure of the emotional center of the brain to react to what would be universally accepted as a repugnant stimulus? [read post]
31 Oct 2012, 12:35 pm
" David Brenner, director of Columbia University's Center for Radiological Research, told ProPublica last year. [read post]
21 Oct 2014, 11:17 pm by Charles Fox
  A study published recently in Radiology showed that even one concussion can structurally change the brain, leading to increased risks of cognitive problems and depression. [read post]
26 Feb 2018, 8:27 am by Laura Mushrush
For example, in the event of a radiological disaster, an animal being raised for human consumption may have high levels of radiation. [read post]
6 May 2010, 5:13 am by Jonathan Rosenfeld
  Sources: WebMD: Osteoporosis Health Center - Osteopenia University of Washington: Department of Radiology – Osteopenia U.S. [read post]
8 Nov 2011, 5:59 am by Blogger Bob
The Johns Hopkins University Applied Physics Lab (APL) and the Food and Drug Administration (FDA)’s Center of Devices and Radiological Health (CDRH) both verified that the advanced imaging technology (AIT) equipment TSA purchased and deployed emits radiation at rates much lower than the limits set in the national radiation safety standard for all members of the traveling public and all TSA employees. [read post]
9 Sep 2011, 6:47 am by Ed Wallis
“The clinical effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse has not been demonstrated,” said William Maisel, deputy director of the FDA Center for Devices and Radiological Health, in a telephone interview. [read post]
16 Aug 2012, 7:17 pm by FDABlog HPM
Jeff Shuren, Director of the Center for Devices and Radiological Health (“CDRH”), expressing their concern “about weaknesses in the premarket review process used to evaluate most medical devices. [read post]