Lynch 'Em (Forbes)
Lawyers and doctors are fighting for drug safety. But where is the FDA?

St. Jude Medical Receives FDA Clearance for ACross Transseptal Access System (Business Wire via Yahoo! Finance)
ST. PAUL, Minn.----St. Jude Medical, Inc. today announced U.S. Food and Drug Administration clearance and a Health Canada License for the ACross Transseptal Access System, a device that improves control and simplifies the procedure physicians use to access the left atrium during complex cardiac procedures such as atrial fibrillation ablation.

Taking another look at managing PMAs (Medical Device Link)
Four years ago, IVD Technology magazine published a series of articles on managing premarket approvals (PMA) for IVDs. 1 3 As an update, this article describes how to manage postmarket PMA activities involving additional FDA approvals for product modifications following initial PMAs, and managing postmarket clinical studies if they are required as a condition for granting a PMA.