Category: Food & Drug Administration (FDA)
By: Marsha Henderson, M.C.R.P.
For one week in May, the nation celebrates women's health. I often find at these celebrations that no one mentions FDA. This is unfortunate, because throughout its100-year history FDA has played a leading role in advancing women's health.
The Honorable Margaret Hamburg, Commissioner, FDA and Dr. Christopher Hickey, Country Director, FDA China
By: Christopher Hickey, Ph.D.
I love history. I especially love the story of Meriwether Lewis and William Clark who, in their famed venture to explore the newly-purchased Louisiana Territory at the direction of U.S. President Thomas Jefferson, fashioned a lean and mean team largely consisting of seasoned, highly qualified frontiersmen.
By Merrill Goozner
Over the angry protests of consumer groups, Congress is moving rapidly – and in bipartisan fashion – to give drug and medical device companies an easier path to Food and Drug Administration approval for some products in exchange for sharply higher user fees to fund the agency.
By Stewart Eisenhart, Emergo Group
The U.S. Food & Drug Administration is planning new premarket notification requirements for manufacturers of X-ray imaging systems used on pediatric patients.
The DePuy hip battle wages on in the pages of the British Medical Journal, St. Jude lands FDA wins for CRM devices reducing unneeded shocks and HeartWare closes enrollment in destination therapy trial for heart pump.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you're still in the know with MassDevice +3.
ProUroCare's ProUroScan prostate imaging system wins FDA clearance as a complement to digital rectal exams, hoping to cut back on the number of unnecessary prostate biopsies by providing 2D an 3D "maps" of the gland.
ProUroCare Medical (OTC:PUMD) won the FDA's okay for its flagship ProUroScan system, a diagnostic imaging device for detecting irregularities in the prostate.
The Minneapolis, Minn.-based company plans this year to launch ProUroScan at "a limited number of top U.S. medical centers in key metropolitan markets," according to a press release.
