If you go in for a computed tomography scan of your abdomen, you’ll be exposed to the equivalent of 400 chest X-rays. As the number of CT scans and other imaging procedures has risen over the past 20 years or so, Americans’ exposure to potentially damaging radiation has escalated as well.
Food & Drug Administration (FDA)
UPDATE: Hamburg, Sebelius say reforms of FDA, healthcare system are coming
WASHINGTON — As the medical device and pharmaceutical industries develop and hone new technologies, the process for regulating those technologies and products needs to keep pace, Food & Drug Administration commissioner Margaret Hamburg said earlier today at the National Health Policy Conference here.
“Just as biomedical and life sciences research has evolved in the past decade, regulatory science … must also evolve,” Hamburg said.
Speaking before a crowd of about 200 people who braved the approximately two-and-a-half feet of snow that blanketed the Washington region over the weekend, Hamburg said the FDA needs to streamline regulatory procedures, which have not kept pace with innovations throughout the life sciences industry.
FDA looks to speed medical device trials
Companies looking to get medical devices to market might want to brush up on their probability theory, after the Food & Drug Administration issued new guidelines for statistical method it says can speed clinical trials.
The FDA said medical device makers can use Bayesian statistical methods to design and analyze clinical trials. Bayesian probability applies an algorithm allowing companies to combine data from previous trials with current trial data. That, in turn, could provide "sufficient justification for smaller or shorter clinical studies," according to a press release.
FDA asks for 23 percent budget boost
The Food & Drug Administration is asking Congress to foot its $4.03 billion bill to overhaul its own operations and increase its scrutiny of the medical device, pharmaceutical, food and tobacco industries.
As it lays out its ambitious plans for fiscal 2011 and beyond, the federal watchdog agency wants a 23 percent boost to its annual budget. The FDA’s FY2010 budget came in at $3.28 billion, itself a 17.5 percent increase over the prior year’s $2.79 billion allotment.
FDA sets panel date for Medtronic’s DBS epilepsy device
Medical devices giant Medtronic Inc. (NYSE: MDT) will go before a Food & Drug Administration panel in early March to seek pre-market approval for its deep-brain stimulator for epilepsy.
The Center for Devices and Radiological Health set a March 12 date for its panel to discuss the company’s implantable device, which stimulates the left and right anterior nucleus of the thalamus to reduce seizures.
FDA, Edwards issue Class I recall of hemodialysis system
The Food & Drug Administration and Edwards Lifesciences Inc. (NYSE:EW) issued a Class I recall of the Aquarius hemodialysis system after reports came in of "clinically significant fluid imbalance."
The device, used to remove waste products and extra fluid from the blood of patients with kidney failure, is designed to monitor the flow of fluid in and out of patients’ bodies and to trigger an alarm if it detects an imbalance. Patients can override the alarm without fixing the problem that caused it (a kink in the line, for example), causing an increase or decrease in patients’ blood volume.
Two agencies that could stand a temporary freeze
By Merrill Goozner
While liberals go ballistic over President Obama’s call for budgetary freeze on discretionary domestic programs, Jared Bernstein, the former Economic Policy Institute economist heading up Vice President Joe Biden’s economics team, points out an overlooked fact in his surprise posting on The Huffington Post: there’s a lot of waste in the federal budget that a freeze can be useful in reallocating. You could create a lot more jobs and social benefit by cutting agricultural subsidies and shifting those dollars to mass transit projects under the rubric of a budget freeze.
FDA to make 510(k) changes by September
Meet the new boss, who is definitely not the same as the old boss.
The Center for Devices and Radiological Health and new director Jeffrey Shuren are looking to shake things up at the Food & Drug Administration’s medical device oversight arm, according to a new set of strategic priorities for 2010 and the following years. The changes include an overhaul of the 510(k) and PMA approval processes, slated to go into effect by September, and a 2013 release date for a unique device identifier system.
FDA seeks public input in 510(k) review
If the 510(k) clearance program for medical devices is the kind of thing that keeps you up at night, the Food and Drug Administration wants to hear from you.
The federal watchdog agency is planning a public meeting Feb. 18 to discuss the program, ahead of internal and external reviews of the process by which some 3,000 medical devices — the majority of the medical device clearance applications submitted to the FDA — are approved each year.
FDA makes Shuren’s appointment as head of medical devices division permanent
The Food & Drug Administration made Jeffrey Shuren permanent director of its division overseeing the medical device industry, the Center for Devices and Radiological Health, according to the Reuters news service.
FDA launches public transparency initiative
The Food & Drug Administration took the first step in its public awareness campaign aimed at shedding more light on what the watchdog agency does on a day-to-day basis.
The FDA unveiled its “FDA Basics” web curriculum, which includes short videos explanations of what the agency does, conversations with agency personnel and a question-and-answer section about the FDA and the products it regulates.
