Category: Boston ScientificSyndicate content

Boston Scientific wins CE Mark for Accolade MRI-safe pacemakers

October 17, 2014 by Brad Perriello

Boston Scientific says it won CE Mark approval in the European Union for its Accolade line of MRI-safe pacemakers.

Boston Scientific wins CE Mark for Accolade MRI-safe pacemakers

Kimberly-Clark plans to spin out Halyard Health as a separately traded company | Medtech Wall Street news for the week of October 13, 2014

October 16, 2014 by MassDevice

Here's a look at some of the top Wall Street stories for medical device companies this week: Kimberly-Clark to spin out Halyard Health Oct. 31; 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device; Irish tax changes may cost U.S. groups billions; InspireMD drops MGuard stent in the U.S., shares slide; ConvaTec owners appoint banks to explore sale: sources

Kimberly-Clark to spin out Halyard Health Oct. 31

October 9, 2014 by Alexander Soule

FDA yanks enhancement reporting requirement

October 15, 2014 by Brad Perriello

The FDA reverses its stance on a requirement that medical device companies report minor enhancements not related to recalls or adverse events.

FDA yanks enhancement reporting requirement

The deletion of a single sentence from the FDA's final guidance on distinguishing medical device recalls from product enhancements eliminated a sore bone of contention between the watchdog agency and the medtech industry.

3rd FDA panel barely favors BSX's Watchman | Regulatory news for the week of October 13, 2014

October 14, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device; Medtronic launches Verify incontinence device in the U.S.; FDA OKs Integra Lifesciences Puerto Rico plant; FDA approves Bard's Lutonix DEB

UPDATE: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device

October 9, 2014 by Brad Perriello

UPDATE: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device

October 9, 2014 by Brad Perriello

An FDA advisory panel's unprecedented 3rd hearing over Boston Scientific's Watchman anti-stroke device barely favors the cardiac implant.

UPDATE: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Edwards Lifesciences is back in Wall Street's good graces | Medtech Wall Street news for the week of October 6, 2014

October 9, 2014 by MassDevice

Here's a look at some of the top Wall Street stories for medical device companies this week: Wall Street loves Edwards Lifesciences again; Becton Dickinson to buy CareFusion for $12 billion in cash, stock; Proxy war rages on at Echo Therapeutics; Platinum fires back at Echo Therapeutics over 'rogue' directors; Echo Therapeutics hits back at Platinum Equity

Wall Street loves Edwards Lifesciences again

October 3, 2014 by Brian Johnson

Edwards: Medtronic TAVI settlement boosts bottom line in Q2

FDA panel offers mixed view on Boston Scientific Watchman device

October 8, 2014 by MassDevice

An FDA advisory panel gives a mixed view in its unprecedented 3rd review of Boston Scientific's Watchman anti-stroke device.

FDA panel offers mixed view on Boston Scientific Watchman device
Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp