Quantcast

Latest Center for Devices and Radiological Health Stories

2011-06-20 11:51:00

Guidance outlines recommendations for clinical trials and pathway to market approval SILVER SPRING, Md., June 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Type 1 diabetes is a chronic condition in which the pancreas produces little or no...

2011-05-31 11:23:00

SILVER SPRING, Md., May 31, 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 31, 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...

2011-05-27 15:33:00

SILVER SPRING, Md., May 27, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Fecal incontinence is the involuntary loss of bowel control. It can have different causes including nerve damage, weakened anal sphincter associated with...

2011-05-24 18:23:39

Northwestern survey finds small companies report more challenges than large companies in FDA's 510(k) product review process; industry and FDA collaboration needed to secure the future of US medical innovation Two-thirds of small medical device and diagnostic companies"“"“the drivers of innovation in the sector"“"“are obtaining clearance for new products in Europe first, suggesting delayed market entry in the U.S., according to a comprehensive industrywide survey about...

2011-05-24 12:17:00

WASHINGTON, May 24, 2011 /PRNewswire/ -- Two-thirds of small medical device and diagnostic companies -- the drivers of innovation in the sector -- are obtaining clearance for new products in Europe first, suggesting delayed market entry in the U.S., according to a comprehensive industry-wide survey about FDA's 510(k) product review process by researchers at Northwestern University. Large and small companies reported that unclear guidelines, inconsistent implementation, and lead reviewer...

2011-05-20 13:57:00

SILVER SPRING, Md., May 20, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today cleared the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving overseas. The Chemical Biological Medical System Joint Project Management Office within the U.S. Department of Defense funded the development of this test, which identifies and detects the bacteria that cause Q fever (Coxiella burnetii) within four hours. The...

2011-05-19 09:36:00

SILVER SPRING, Md., May 19, 2011 /PRNewswire-USNewswire/ -- On May 18, the U.S. Food and Drug Administration cleared the first test to help determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis, sometimes known as cat scratch disease, developed the infection within the past four months. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Toxoplasmosis is caused by the parasite Toxoplasma gondii. The infection can cause serious...

2011-05-18 08:17:00

WASHINGTON, May 18, 2011 /PRNewswire/ -- What: Investigators from Northwestern University will release a new, in-depth analysis of FDA's 510(k) regulatory pathway--through which more than 90% of medical devices receive clearance--and of industry's practices within it. The study is the most comprehensive survey to date about the 510(k) process. FDA's Center for Devices and Radiological Health (CDRH) is currently weighing regulatory revisions that support innovation; bring important,...

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...


Word of the Day
cacodemon
  • An evil spirit; a devil.
  • A nightmare.
  • In astrology, the twelfth house of a scheme or figure of the heavens: so called from its signifying dreadful things, such as secret enemies, great losses, imprisonment, etc.
'Cacodemon' comes from a Greek term meaning 'evil genius.'
Related