Search for: "WILLIAM MAISEL"
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30 Mar 2012, 5:00 am
William Maisel, explained his goal of blocking products from entering the market with unnecessary alarms. [read post]
28 Jan 2011, 2:27 am
William Maisel. [read post]
28 Jan 2011, 3:31 am
William Maisel. [read post]
5 Aug 2009, 1:19 pm
Speaking in support of the bill were William Maisel, Director of the Medical Device Safety Institute, Thomas McGarity, Professor at the University of Texas School of Law, and Michael Mulvihill, a patient who was formerly implanted with a medical device. [read post]
28 Aug 2008, 2:43 pm
Public health physician, William H. [read post]
9 Dec 2015, 4:02 pm
“When a product is developed for use in the battlefield, it is generally intended to work in a worst-case scenario where advanced care might not be immediately available,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. [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]
PREEMPTIOn (which means you cannot sue a medical device company, because Federal law may prevent it)
12 May 2008, 6:24 am
Committee on Oversight and Government ReformWednesday, May 14, 2008, 10:00 AM at 2154 Rayburn House Office Buildinghttp://www.oversight.house.gov/Witnesses: Actor Dennis Quaid and his wife Kimberly, parents of newborn twins, Thomas Boone Quaid and Zoe Grace Quaid, who were victims of a heparin overdose; William Maisel, director of the Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston; Aaron Kesselheim of the Harvard Medical… [read post]
12 May 2008, 12:30 pm
The star studded cast of witnesses includes Dennis Quaid (whom I imagine will speak to the heparin overdose of his twins), William Maisel, (Medical Device Safety Institute), Aaron Kesselheim (Harvard Medical School's Division of Pharmacoepidemiology), David Kessler (former FDA head), David Vladeck, (Georgetown law professor who has written on preemption) Gregory Curfman (New England Journal of Medicine editor); Christine Ruther (drug company consultant) and State… [read post]
12 May 2008, 12:30 pm
The star studded cast of witnesses includes Dennis Quaid (whom I imagine will speak to the heparin overdose of his twins), William Maisel, (Medical Device Safety Institute), Aaron Kesselheim (Harvard Medical School's Division of Pharmacoepidemiology), David Kessler (former FDA head), David Vladeck, (Georgetown law professor who has written on preemption) Gregory Curfman (New England Journal of Medicine editor); Christine Ruther (drug company consultant) and State… [read post]
27 Aug 2009, 9:46 am
William Maisel, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston and chairman of the FDA's Circulatory Advisory Committee, told the Senate the obvious: it is "simply impossible" for the FDA to continue to monitor the safety of every medical device it has approved. [read post]
13 May 2009, 7:33 am
William H. [read post]
22 May 2014, 3:13 pm
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. [read post]
8 Nov 2022, 8:56 pm
William Maisel, Chief Medical Officer and Director at CDRH’s Office of Product Evaluation and Quality, shared FDA’s experience with EUAs over the last two and a half years as well as more detail on transition planning for those devices marketed under an EUA or enforcement policy (EP). [read post]
30 Aug 2011, 8:26 pm
Williams Maisel stated:"The added benefit of using the mesh is not evident, but there certainly appears to be an added risk," Over half a million women each year have surgery for incontinence of pelvic organ collapse and have had this mesh inserted through the vagina. [read post]
14 Feb 2011, 9:40 am
William Maisel, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health stated that “[t]his important mobile technology provides physicians with the ability to immediately view images and make diagnosis without having to be back at the workstation or wait for film. [read post]
12 Apr 2011, 6:57 pm
William Maisel, chief science officer for the FDA's Center for Devices & Radiological Health; David Nexon of the Advanced Medical Technology Association; and Ralph Hall, a professor at the University of Minnesota Law School. [read post]
7 Apr 2016, 6:14 am
“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientific in the FDA’s Center for Devices and Radiological Health. [read post]
19 Jan 2015, 7:14 am
” William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, told reporters Monday “We believe the recommendations are appropriate and put appropriate restrictions on the use of laparoscopic power morcellation. [read post]
16 Dec 2013, 10:19 am
William Maisel, chief scientist at the FDA’s device unit, defended the BSD study ordered by the agency. [read post]
