FDA Approves New Atrial Fibrillation Device

The FDA has approved Boston Scientifics new device for stroke patients with irregular heart rhythm known as atrial fibrillation, and will be made available to U.S. centers involved in Boston Scientific’s clinical studies and additional specialized centers,...

How to Win with the FDA

Getting regulatory approval from the FDA can prove to be a lengthy and frustrating process, with many procedures and processes that must be followed.  Take a look at this article about “a heated public debate that took place during a recent FDA advisory...

Brookings Releases $250M Plan for Medical Device Tracking

The Brookings Institution has released a $250M plan for a postmarket medical device tracking system, under an arrangement with the FDA.  According to FedScoop.com, “under the plan, the National Medical Device Postmarket Surveillance System would use the...