They gave him a sword and he handed them the world.When William Hawkins officially flipped the keys to Medtronic Inc. (NYSE:MDT) over to successor Omar Ishrak, he offered a simple message and a gift. The message was clear ’ don’t lose sight of founder Earl Bakken’s mission to alleviate pain, restore health [...]

The recent report of a computer security expert who hacked his own insulin pump got the attention of members of the House Energy & Commerce Committee.This week senior committee members Anna Eshoo (D-CA) and Edward Markey (D-MA) urged the Government Accountability Office to investigate the safety and security of wireless medical [...]

The FDA planned a public workshop for mid-September to discuss the recently released draft guidance regarding regulation for mobile medical apps.The guidance includes a fairly narrow subset of medical apps, covering those that are used as accessories to medical devices and those that transform a mobile platform into a regulated medical [...]

Medtronic Inc. (NYSE:MDT) landed a $1.6 million aid package from the Jacksonville City Council, which is hoping the company will expand its Medtronic Xomed surgical technology facility.“This is exactly the kind of thing we need to be doing in Jacksonville,” Councilman Bill Bishop told members of the Rules Committee during [...]

The FDA set an August 23 date for a final rule for three “fallen angel” class III devices to submit premarket applications or be taken off the market as their existing 510(k) cleared status has been revoked.The term “fallen angel” refers to medical devices that were once candidates for the FDA’s fast-track [...]

Paulson & Co. Inc. is Boston Scientific Corp.’s (NYSE:BSX) largest shareholder no more, after liquidating its position in BSX completely by selling off some 15 million shares of the Natick, Mass.-based medical device company during the second quarter.The New York-based fund has been steadily selling off its BSX shares for more than [...]

Abbott (NYSE:ABT) enrolled its first patients in a Japanese trial of the Absorb bioresorbable vascular scaffold.The Absorb stent opens clogged blood vessels and provides support to restore blood flow, and dissolves within about two years.Since the stent dissolves rather than leaving behind a metal scaffold, the treated vessel may be able to regain [...]

The cardiac rhythm management industry looks like it needs of a jolt of its own, badly.A look at the earnings releases of two of the big three players in the CRM Market, Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ), reveals that the slump in the cardiac rhythm management business is more persistent than some [...]

The FDA released a new guidance yesterday detailing the agency’s process of making benefit-risk determinations when assessing premarket applications for medical devices for “reasonable assurance of safety and effectiveness.”The agency hopes to provide clarity for both industry and its reviewers by outlining what sorts of factors are taken into consideration when considering PMAs, the most [...]

The FDA took bold steps to outline expectations for medical device premarket submissions in the release of a new draft guidance that outlines the basic structure for clinical trials.The document attempts to the foundational features of medical device trials, including what types of studies may be appropriate, how to avoid bias in subject or site [...]