Boston Scientific receives FDA approval for heart device lead (WPRI 12 Providence)
NATICK, Mass. Medical device maker Boston Scientific wins F-D-A approval for one of its heart device leads. It's the Natick-based firm's first new product since the agency lifted a hold on company approvals.The electrode system can be placed within the heart by snaking it through blood vessels.

NEJM Publishes Several Perspectives On FDA User Fee Reauthorization, Prescription Drug Safety (Medical News Today)
Drug Safety Reform at the FDA -- Pendulum Swing or Systematic Improvement?" New England Journal of Medicine: In the perspective, former FDA Commissioner Mark McClellan discusses an Institute of Medicine report that focused on FDA drug approval and postmarket safety and how recommendations could affect user fee reauthorization (McClellan, NEJM, 4/13). [click link for full article]

Boston Scientific Announces FDA Approval of Innovative Heart Failure Lead (FinanzNachrichten)
NATICK, Mass., April 17 /PRNewswire-FirstCall/ -- Boston Scientific Corporation ( Nachrichten ) today announced U.S. Food and Drug Administration (FDA) approval of the ACUITY(R) Steerable left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure.