Being hospitalized for anything is traumatic to most people; the insult and threat on top of that is the hospital-acquired deadly infection known as methicillin-resistant Staphylococcus aureus (MRSA). Current diagnostic techniques take days. Newcomer MicroPhage (Longmont, Colorado) has just submitted human data from a pivotal clinical study of its MRSA/MSSA (methicillin-sensitive Staphylococcus aureus) Blood Culture Test to support FDA 510(k) clearance of the test that produces results onsite in five hours. (Medical Device Daily)
The price that Boston Scientific (Natick, Massachusetts) has paid for troubled cardiac rhythm management firm Guidant has far exceeded its 2006 winning bid of $27.2 billion. Plagued with product liability problems, Guidant has cost Boston Sci millions more to settle lawsuits related to electrical flaws in its implantable cardioverter defibrillators (ICDs). And now those troubles have led to alleged criminal violations of the Federal Food, Drug, and Cosmetic Act. Charges were filed yesterday by the Department of Justice (DOJ) in federal district court in St. Paul, Minnesota. (Medical Device Daily)