In a recent issue of Medical Device Daily, Integrity Life Sciences (ILS; Tampa) reported that FDA will investigate the use of robotic surgery, a move said to be sparked by a tripling of adverse events reports between 2008 and 2012. The company statement indicates that the more than 1,400 U.S. hospitals deploying surgical robots have filed enough reports to render a report rate that is a "higher than acceptable rate," although the announcement acknowledges that the data do not clearly disclose whether "the failure is attributable to the robot itself, operator error, the FDA marketing clearance process, or the training...

For years, numerous companies have been developing implantable devices to stimulate the vagal nerve for treatment of such diverse conditions as epilepsy, depression, asthma, chronic obstructive pulmonary disease (COPD), cluster headaches and for weight loss. Now, a company has come along with a potentially game changing technology that can non-invasively stimulate the vagal nerve.

SAN FRANCISCO — When Omar Ishrak took over 18 months ago as CEO of Medtronic (Minneapolis), one of the largest med-tech companies in the world, he identified some major changes he wanted to make both in strategy and internal structure. During a wide-ranging interview with Medical Device Daily at the J.P. Morgan Healthcare Conference, Ishrak noted that much has been accomplished, but he stressed that the company still has more to do in order for it to be at the level that he has envisioned for Medtronic's future.

We have been hearing a lot about the death of innovation in the field of medical technology for the past few years, a victim; it would appear, of a sluggish worldwide economy and more stringent regulation and reimbursement policies. However, a closer look reveals that medical device innovation is still very much alive, and will continue to thrive both in the U.S. and overseas. Medical Device Daily’s “Med-Tech on a Mission: Strategies to Drive Innovation” addresses the status, prospects and challenges that epitomize this market and identifies distinctive research agendas and tactical business development approaches that have the proven records,...

By Steve Deaton MDD Perspectives Contributing Writer Editor’s note: Steve Deaton is the vice president of sales at Viztek, a provider of complete digital software and hardware imaging solutions for the med-tech industry. In healthcare there is an evolving trend of making data accessible and easily sharable, and this change is being enabled through cloud-based infrastructure.. The cloud eliminates the need for on-site server space and maintenance through virtual servers that are both secure and flexible. A broad shift to cloud services in healthcare will have multiple implications for both physicians and their patients. The Cloud Brings Changes for Patients...

With all the acrimony between Democrats and Republicans in Congress these days, it was truly edifying to see lawmakers on both sides of the aisle agreeing on a piece of legislation - and in the healthcare sector no less - the FDA user fee reauthorization act. Last week, the U.S. House of Representatives reaffirmed passage of the FDA user fee reauthorization act in a 387-5 roll call vote taken after an earlier voice vote. The House affirmation followed close on the heels of the earlier congenial vote on the act by the Senate, a nearly unanimous 96-1 approval. The groundwork...

In the March 15 issue of Medical Device Daily, there were two stories that discussed the medical technology industry in the U.S., and neither of them cast a particularly flattering light on the current state of affairs. In fact, it appears that this once proud and successful domestic industry is on life support. Perhaps the most credible criticism came from Tom Fogarty, a legendary entrepreneur in the medical device field. In a story written by Senior Staff Writer Amanda Pedersen, Fogarty asserted that “it’s reached a point in the field of medicine that we in the U.S. are no longer...