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Latest Center for Devices and Radiological Health Stories

2011-04-08 16:02:00

SILVER SPRING, Md., April 8, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever, a leading cause of illness and death in the tropics and subtropics. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The dengue virus is transmitted to humans by the bite of an infected Aedes mosquito. As many as 100 million people worldwide are...

2011-04-08 14:50:00

New product protects against infection from microorganism, body fluids, other material SILVER SPRING, Md., April 8, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration cleared the SpectraShield 9500 N95 surgical respirator, a device that kills 99.99 percent of three different kinds of bacteria when exposed to its outer surface. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The FDA cleared the SpectraShield as a single-use, N95 surgical respirator for use...

2011-04-08 13:00:00

Clostridium difficile can lead to diarrhea, colitis SILVER SPRING, Md., April 8, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today cleared a test called the Cepheid Xpert C. difficile/Epi assay that is designed to rapidly detect the toxin B gene associated with Clostridium difficile infection (CDI), a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death in severe cases. (Logo:...

2011-02-23 11:29:00

Test can aid in identifying and containing norovirus outbreaks SILVER SPRING, Md., Feb. 23, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration allowed marketing of the first test for the preliminary identification of norovirus. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The Ridascreen Norovirus 3rd Generation EIA assay is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission,...

2011-02-14 11:25:00

Rule provides more predictable path to market SILVER SPRING, Md., Feb. 14, 2011 /PRNewswire-USNewswire/ -- Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards. (Logo:...

2011-02-08 09:00:00

DARPA-funded prosthetic is first test case SILVER SPRING, Md., Feb. 8, 2011 /PRNewswire-USNewswire/ --Today the U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly. (Logo:...

2011-02-07 09:30:00

Agency wants data on length of time before removal, replacement SILVER SPRING, Md., Feb. 7, 2011 /PRNewswire-USNewswire/ -- Today the U.S. Food and Drug Administration ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The TMJ connects the lower jaw (mandible) to...

2011-02-04 12:20:00

Provides wireless access to medical images for iPhone, iPad users SILVER SPRING, Md., Feb. 4, 2011 /PRNewswire-USNewswire/ -- A new mobile radiology application cleared today by the U.S. Food and Drug Administration will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed...

2011-01-19 12:00:00

Goals are to foster device innovation, protect patient safety SILVER SPRING, Md., Jan. 19, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Key actions include: Streamlining the "de novo" review process for certain innovative, lower-risk medical devices, Clarifying...

2011-01-18 06:00:00

MOUNTAIN VIEW, Calif., Jan. 18, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010. A CRL is issued by FDA's Center for Drug...


Word of the Day
penuche
  • A fudgelike confection of brown sugar, cream or milk, and chopped nuts.
'Penuche' is a variant of 'panocha,' a coarse grade of sugar made in Mexico. 'Panocha' probably comes from the Spanish 'panoja, panocha,' ear of grain.
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