Competition from Medtronic plc hurt Boston Scientific Corp.'s cardiac rhythm management (CRM) business in the fourth quarter, analysts noted after Boston Scientific reported its earnings for the quarter.
The mood was pretty somber going into Heartware's (Framingham, Mass.) breakout session during the 34th annual J.P. Morgan Healthcare conference. But why wouldn't it be? It's not everyday that a med-tech CEO has to discuss halting a European trial on one of its most promising technologies.
The negotiations for the next user fee schedule are well underway, and the FDA and device makers are addressing what some in industry see as sore spots. The FDA's proposals include development of a "myDevice" portal to allow for a more streamlined and interactive premarket review process, but the FDA has also said it would address the persistent draft status of guidances, vowing to take measures to ensure that guidances "are finalized in a timely manner."