FDA Approvals - The Handle on Hansen Medical (The Motley Fool) The company's
The Handle on Hansen Medical (The Motley Fool)
The company's robotics help doctors put catheters in place.
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.