All hell broke loose in Europe last year after a French manufacturer was busted for substituting an industrial grade silicon in breast implants with a sub-standard gel used in mattresses. The European Parliament issued the PIP Resolution about a year ago demanding a credible response to the scandal in which up to 500,000 women in 65 countries may have received implants from Poly Implant Prothese (PIP; La Seyne-sur-Mer, France).

GE Healthcare (Princeton, New Jersey) reported FDA approval of a new indication for AdreView (Iobenguane I 123 Injection), a molecular imaging agent, to link nerve function in the heart to a patient's mortality risk.

Charles Dickens at his desk in 1858. Dickens' famous opening line from "A Tale of Two Cities" could easily be applied to the current state of the medical device industry, "It was the best of times, it was the worst of times." Here at Medical Device Daily we've become accustomed to the doom-and-gloom stories about our industry. The medical device tax provision in the Affordable Care Act and other emerging realities of healthcare reform along with worldwide economic sluggishness, regulatory and reimbursement challenges, consolidation among hospitals and an increase in hospital-employed physicians has created the perfect storm for the medical device industry....