Latest Radiological Health Stories

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:...

2011-01-19 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...

2010-10-18 12:47:00

HACKENSACK, N.J., Oct. 18 /PRNewswire/ -- ReGen Biologics Inc. is taking exception to the FDA's Center for Devices and Radiological Health's (CDRH) Thursday announcement of a plan to rescind the 510(k) clearance of the company's Menaflex knee implant. "For CDRH to arrive at the decision that the device has a new intended use four years after two senior CDRH officials informed the company that the device could be reviewed through the 510 (k) program is totally unbelievable," said Gerald E....

2010-04-26 14:28:00

Goal is improved discussion and flow of information SILVER SPRING, Md., April 26 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval, effective May 1, 2010. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) The changes were prompted by an increasing number of medical device advisory...

Word of the Day
  • The offense of persistently instigating lawsuits, typically groundless ones.
  • An unlawful breach of duty on the part of a ship's master or crew resulting in injury to the ship's owner.
  • Sale or purchase of positions in church or state.
This word ultimately comes from the Old French word 'barater,' to cheat.