Regulatory/Legal
Nov 30, 2006
The Cleveland Clinic analyzed the data 14 studies covering 6675 patients and concluded that drug-eluting stents are 4-5 times more likely to cause blood clots...
Nov 29, 2006
Medtronic yesterday lost its bid to dismiss the hundreds of lawsuits filed against it in the wake of last year's recall of implantable cardioverter-...
Nov 20, 2006
It would have been easy for FDA to maintain the 14-year ban on silicone-gel breast implants. The ban had a number of vocal proponents, and the controversy from...
Nov 16, 2006
Senator Edward M. Kennedy (D-MA), who will take over leadership of the Senate Committee on Health, Education, Labor, and Pensions when the next Congress is...
Nov 13, 2006
Last week FDA outlined a plan to strengthen its monitoring of medical devices after they hit the market. The report by the Postmarket Transformation ...
Nov 10, 2006
While many manufacturers continue to be up in arms about gainsharing, investors have little concern. According to David Blaszczak, senior vice president and ...
Nov 09, 2006
EP MedSystems Inc. (West Berlin, NJ) said it will pay $244,000 to settle claims by the US Department of Commerce that it shipped products to Iran in 2004 and...
Nov 09, 2006
Stories published this morning, including by the Washington Post and Bloomberg News, are analyzing what the Democrats will do now that they have control of the...
Nov 01, 2006
CVRx Inc. (Maple Grove, MN) received a go-ahead this week from FDA to begin U.S. clinical trials on a device that uses electrical stimulation to treat high...
Oct 26, 2006
After a device receives PMA approval, its manufacturer must file a report annually with FDA updating it on manufacturing, design, and labeling changes, among...