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15 Apr 2011, 9:00 am by Lucas A. Ferrara, Esq.
If you want to learn more about breast implants and ALCL, visit the FDA's Center for Devices and Radiological Health. [read post]
20 Nov 2007, 6:39 am
A high percentage (over 10%) of mammogram codes submitted as post-screening diagnostic studies is unusual unless the facility serves as a center specializing in patients with known positive findings on previous exams. [read post]
28 Jan 2015, 6:00 am by Christopher Hoffmann
Minimally invasive procedures are normally performed in outpatient centers where patients can undergo surgery and go back home the same day. [read post]
26 Jan 2008, 9:54 am
As the car passes people, their cell phones individually would send signals to a command center, allowing authorities to track the source. [read post]
23 Apr 2022, 4:33 am by Jeff DeFrancisco
History of the Case It is alleged that the decedent presented to the defendant’s radiology center for CT scans of the chest on numerous occasions from 2011 through 2014. [read post]
30 Jan 2009, 7:06 am
The complaints go back to November of 2008 when the House Energy and Commerce Committee received a letter from scientists at the FDAs Center for Devices and Radiological Health division. [read post]
14 Feb 2011, 9:00 am by Lucas A. Ferrara, Esq.
., director of the FDA's Center for Devices and Radiological Health. [read post]
19 Jul 2011, 12:40 pm
The director of the FDA's Center for Devices and Radiological Health (who is a physician and a lawyer) has noted: " 'The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery ... [read post]
17 Mar 2023, 10:27 am by Simmons Hanly Conroy
In fact, in 2022, Jeff Shuren, the FDA’s Director of the Center for Devices and Radiological Health, said the company needed to improve its communication efforts surrounding the recall since many users may not even be aware of the risks. [read post]
28 Jan 2011, 2:27 am by Bob Kraft
” The New York Times reports in some cases, simply “removing the implant and scar tissue gets rid of the disease, but some women might need chemotherapy and radiation,” said Center for Devices and Radiological Health Deputy Director Dr. [read post]
24 Mar 2011, 9:00 am by Lucas A. Ferrara, Esq.
., deputy director for science at the FDA's Center for Devices and Radiological Health. [read post]
14 Dec 2016, 2:07 pm by James Hoffmann
Another estimate by Centers for Disease Control and Prevention (CDC) shows that nearly 2,000 American workers suffer a work related eye injury requiring medical treatment each year. [read post]
27 Jan 2010, 6:47 am
" Jon Casamento, deputy director of the Solid and Fluid Mechanics Division at the FDA's Center for Devices and Radiological Health, said the "defective needles...may cause tissue damage and inadequate drug delivery. [read post]
15 Feb 2008, 10:16 am
Department of Commerce, The Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency, the Office of Technical Information and Publications of the National Bureau of Standards, The Food and Drug Administration, the Bureau of Radiological Health, The National Highway Traffic Safety Administration, The Federal Highway Administration, The Transportation Research Board, The United States Coast Guard, the Federal Aviation Administration, the National… [read post]
19 Aug 2010, 12:21 pm by FDABlog HPM
” The additional time also will provide interested parties with time to consider two preliminary reports regarding the 510(k) process and the use of science in the Center for Devices and Radiological Health (CDRH). [read post]
26 Aug 2012, 3:00 pm by FDABlog HPM
Phelps – According to recent reports concerning the widely reported “whistleblower” scandal at FDA’s Center for Devices and Radiological Health (“CDRH”), in 2009, the CDRH dissidents involved in the affair, while still employed at FDA, filed a “secret” Federal False Claims Act suit against 15 medical device manufacturers. [read post]
30 Nov 2011, 4:00 am
In certain cases the issue may be at the center of a medical malpractice lawsuit. [read post]
19 Feb 2012, 6:32 pm
Susan Runner, branch chief for Dental Devices in the FDA’s Center for Devices and Radiological Health. [read post]
19 Feb 2009, 4:22 pm
The Center for Devices and Radiological Health, which is the FDA division that oversees medical devices, has received complaints from its own scientists who claim managers have discouraged debate and that this has resulted in the approval of medical devices that are not entirely safe or effective. [read post]
21 Jan 2011, 2:40 pm by Lisa Baird
On January 19, 2011, FDA announced its long-awaited plans for revising the premarket notification (510(k)) process for medical devices to address the concerns that have been raised about the process by industry, consumers and Center for Devices and Radiological Health (CDRH) staff regarding the lack of predictability, consistency, transparency of the process, the inadequacy of the process to ensure the safety and effectiveness of products, and the lack of flexibility of the process… [read post]