Regulatory/Legal
Jul 20, 2006
Several potentially significant products have received FDA approval this week: Medtronic won clearance for its Guardian REAL-Time continuous glucose...
Jul 19, 2006
Industry giant Medtronic Inc. yesterday agreed to pay the federal government $40 million to settle accusations that its spinal unit, Medtronic Sofamor Danek,...
Jul 17, 2006
An implantable telescope that would serve as a bionic eye has received a setback in development after FDA's ophthalmic devices panel voted 10-3 against...
Jul 14, 2006
FDA has canceled the Blood Products Advisory Committee meeting scheduled for today because of calls for it to be made open to the public. At issue, reports the...
Jul 12, 2006
FDA announced that it met last week with Boston Scientific to discuss its latest recall plan and that it endorses the steps the company has taken so far. The...
Jul 10, 2006
Bowing to growing calls for public disclosure about medical procedures, CMS said it would post data on its Web site today about implantable cardioverter-...
Jul 05, 2006
Massachusetts is considering whether to publicize patient death rates for individual physicians who perform bypass surgery and angioplasty, reports the Boston...
Jun 30, 2006
Baxter Healthcare Corp. has signed a consent decree with FDA to stop making and distributing two brands of infusion pumps until manufacturing deficiencies are...
Jun 29, 2006
The New York Times reports that a Sanford C. Bernstein...
Jun 28, 2006
FDA has unveiled the Human Subject Protection and Bioresearch Monitoring Initiative, which aims to modernize the regulation of clinical trials and bioresearch...