Regulatory/Legal
Sep 27, 2007
Five orthopedics companies have settled with the U.S. Department of Justice over allegations that they may have paid kickbacks to surgeons in return for...
Sep 27, 2007
A Texas man is suing Medtronic, its Sofamor Danek subsidiary, three tissue processing companies, and two individuals after he found out a bone implanted in his...
Sep 26, 2007
Yesterday FDA classified the recall of Baxter Healthcare's 66 Colleague brand infusion pumps as a Class I recall, according to the Associated Press. The...
Sep 25, 2007
A federal judge in Delaware failed to throw out a jury's verdict that the company's Cypher stent infringed on a Boston Scientific patent that covers drug...
Sep 20, 2007
The House yesterday passed a House-Senate compromise version of a sweeping FDA reform bill that includes the new version of the Medical Device User Fee and...
Sep 18, 2007
It's not every day that you see a mainstream media piece that goes into detail about a particular regulatory process. But today's Boston Globe has a piece that...
Sep 10, 2007
FDA has sent a warning letter to Boston Scientific over inadequate recordkeeping and reporting stemming from the deaths of five patients in a clinical trial,...
Sep 07, 2007
The New York Times reports that the Senate introduced a bill today aimed at tightening the rules surrounding payments and gifts to doctors. What is...
Aug 29, 2007
FDA has approved a test that can detect West Nile Virus in donated human blood and plasma. Manufactured by Roche Diagnostics, the test is only one of two on...