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Latest Center for Devices and Radiological Health Stories

2011-05-06 12:50:00

SILVER SPRING, Md., May 6, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today cleared the first test for Staphylococcus aureus (S.aureus) infections that is able to quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA). (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) There are many different types of Staphylococci bacteria, which cause skin infections, pneumonia, food and blood infections (blood...

2011-05-06 10:55:00

SILVER SPRING, Md., May 6, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved an expanded indication that will allow a new group of patients at risk of stroke due to clogged neck arteries to be treated with the RX Acculink carotid stent. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The carotid arteries on each side of the neck bring blood to the brain. The blood flow in the arteries can become partially or totally blocked by fatty material...

2011-05-02 11:57:00

SILVER SPRING, Md., May 2, 2011 /PRNewswire-USNewswire/ --Science, public health, and regulatory highlights for this week from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of May 2, 2011. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations. Meetings, Workshops and...

2011-04-29 11:05:00

Agency to collaborate with other groups on proper reprocessing SILVER SPRING, Md., April 29, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to the transmission of disease. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances...

2011-04-15 14:14:00

SILVER SPRING, Md., April 15, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration recently approved the NovoTTF-100A System, a new device to treat adults with glioblastoma multiforme (GBM) that recurs or progresses after receiving chemotherapy and radiation therapy. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Brain tumors are the growth of abnormal cells in the brain tissue. According to the National Cancer Institute, each year about 19,000 people in the...

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:...


Word of the Day
abrosia
  • Wasting away as a result of abstinence from food.
The word 'abrosia' comes from a Greek roots meaning 'not' and 'eating'.