An expert witness in a trial over recalled hip implants was extensively cross-examined as to whether he had a bias in favor of the manufacturer of the medical devices, after he claimed that the implant was harmless. Dennis Paustenbach said in the trial in Los Angeles that the patient, Loren Kransky, was not harmed by [...]
FDA Seeks Comments on Limiting Weather’s Effects on Medical Device Industry
February 25, 2013 By Leave a Comment
The Midwest was hit last week with a blinding snow storm that put an inch of snow on the ground every hour in some places and walloped the area with 35 mph winds. Hurricane Sandy’s storm surge last October flooded New York’s streets and subways and devastated New Jersey communities. Events like these can interrupt [...]
FDA Wants Safer Use of Medical Devices at Home
December 20, 2012 By Leave a Comment
More people are using medical devices at home, and there are some safety risks involved in that trend, says the U.S. Food and Drug Administration (FDA). But resources are available to lessen those risks, the agency says. It used to be that patients needed medical devices just to stay alive. Now they help people be more [...]
FDA Advised to Improve Medical Devices’ Security
October 9, 2012 By Leave a Comment
Here’s something else to worry about: your medical device may be a target of a cyberthreat. That’s what the Government Accountability Office (GAO) is saying, at least. In a new report (PDF), the government accounting agency recommended that the U.S. Food and Drug Administration (FDA) start focusing on medical device manufacturers’ identification of potential unintentional and [...]
FDA Wants Data on Defibrillator Devices
September 7, 2012 By Leave a Comment
The U.S. Food and Drug Administration (FDA) has ordered a medical technology company to understand the cause and extent of failures of its heart-device components that have been linked to as many as 20 deaths. FDA says that St. Jude Medical needs to conduct studies to find out why its Riata defibrillator leads, which were [...]
Polymers Prevent Infections on Medical Devices
August 17, 2012 By Leave a Comment
British researchers have developed a new class of polymers that they say can repel bacteria, preventing medical-device-associated infections, medical device failure, and save England’s healthcare system £1 billion per year. The polymer designed by researchers at University of Nottingham can be applied to the surface of medical devices, such as catheters, and prevent them from [...]
FDA Authorization Bill Heads to Conference
June 4, 2012 By 1 Comment
The Senate and House of Representatives have passed their bills that authorize the U.S. Food and Drug Administration (FDA) to collect user fees so that the agency can review new drugs and medical devices, and they are heading to a conference to be reconciled. The legislation reauthorizes the FDA’s drug and medical user fee programs [...]
FDA Speeds Dialysis Devices to Patients
April 11, 2012 By Leave a Comment
Novel kidney dialysis devices will be available to patients faster, under a new plan launched by the U.S. Food and Drug Administration (FDA) designed to respond to medical innovation. The program, “Innovation Pathway,” aims to reduce the time and cost of bringing safe and effective breakthrough technologies to patients, FDA says in a press release. [...]
Metal Hip Implants Could Have New Testing Standards
April 6, 2012 By 4 Comments
The possibility of new testing standards for metal-on-metal hip replacement systems could have implications for plastic implants. Reuters reported on March 29 that the Food and Drug Administration (FDA), because of increasing concerns about the safety of the metal systems, will sponsor an advisory panel on June 27-28 to gather input from scientists, researchers, patients, [...]
Medical Device Industry Wants FDA to Change
May 5, 2011 By 1 Comment
Venture capitalists, companies, and lobbyists are beginning to apply a lot of pressure to the U.S. Food and Drug Administration (FDA) to change the way it handles medical device applications. They argue the FDA’s handling of medical devices is stifling innovation in the U.S. As reported by Luke Timmerman in a Xconomy.com article that got [...]
