A Blueprint for More U.S. Early Feasibility Studies

According to MDDIonline.com, “A public-private partnership has put forth a draft blueprint intended to give medical device companies a helping hand in planning and conducting early feasibility studies (EFS) in the United States.  Ensuring that medical device...

ICYMI: UPDATE 1-Medtronic’s Wireless Pacemaker Wins U.S FDA Nod

According to Reuters, “Medtronic Plc’s wireless pacemaker was approved by the U.S. Food and Drug Administration on Wednesday, making it the first pacemaker in the United States that does not need wired leads to correct slow heart rates.”  For more...

FDA Mulling Powdered Surgical Glove Ban

According to an article on WashingtonPost.com, “Powdered medical gloves — the kind used in surgery or to examine patients — would be ordered off the market under a new proposal by the Food and Drug Administration…The FDA said the aerosolized powder on...