News
Apr 29, 2015
It's no secret that hospitals are under tremendous pressure as a new healthcare paradigm emerges. And a new report suggests that they are seeking help in...
Apr 28, 2015
Arundhati Parmar Medtronic's SynchroMed II Implantable Infusion Pump   A new report from Lifescience Alley, a Minnesota life sciences association...
Apr 28, 2015
Marie Thibault Since February 2014, CDRH has been reviewing PMAs that were approved prior to 2010 as part of its priority to "Strike the Right Balance...
Apr 23, 2015
Marie Thibault At a Senate Committee on Finance Subcommittee on Health Care hearing held Thursday morning, the chief financial officer of B. Braun, a major...
Apr 22, 2015
  Orthopedics manufacturer Stryker reported a good quarter Tuesday with earnings per share beating what analysts were expecting. Analysts and company...
Apr 21, 2015
  St. Jude Medical, through its Nanostim acquisition, was the first to win regulatory clearance for its leadless pacemaker back in October 2013 in Europe...
Apr 21, 2015
Marie Thibault FDA has set out its current thinking about data from clinical studies conducted outside the United States (OUS) in a draft guidance published...
Apr 20, 2015
Marie Thibault FDA has put out a call for makers of home-use medical devices to consider participating in a pilot program that would create an online...
Apr 20, 2015
St. Jude Medical announced Monday that it has exercised the option buy Spinal Modulation, a company in which it had previously invested $40 million. The...
Apr 17, 2015
Marie Thibault The HeartMate II LVAD is being studied in the ROADMAP postmarket study. Thoratec presented one-year results from its real-world study, ROADMAP...