The FDA hearing addressing regulatory requirements for leadless pacemakers took up a number of issues associated with a device type that has been available in Europe for nearly three years now. Despite the extensive experience in other national jurisdictions, the advisory committee recommended that the agency not allow device makers to enroll patients from their pivotal studies into post-approval studies, which would require a new enrollment of more than 1,700 patients for each device.

The FDA has approved St. Jude Medical Inc.'s multipoint pacing (MPP) technology for the company's Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D), the Quadra Allure MP CRT-pacemaker (CRT-P) and two new quadripolar Quartet LV leads.

After staying mostly on the sidelines of merger and acquisition activity last year, Stryker Corp. said it would be an active buyer and put its strong balance sheet to work this year. Representing the most recent step in that direction, the company agreed to shell out $1.28 billion for Physio-Control, a portfolio company of Bain Capital Private Equity that makes monitors and defibrillators, automated external defibrillators (AEDs) and CPR-assist devices along with offering data management and support services.