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FDA warning letter to Cook Medical finds problems during inspections of plant | Regulatory news for the week of November 3, 2014

November 4, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: FDA warns Cook Medical on 'nonconformance' issues; Abiomed jumps on FDA deal for Impella indication; Hansen Medical launches 3rd-gen Sensei surgical robot; Medtronic wins EU nod for Resolute Onyx stent

FDA warns Cook Medical on 'nonconformance' issues

October 28, 2014 by Brad Perriello

Hansen Medical launches 3rd-gen Sensei surgical robot

October 31, 2014 by Val Kennedy

Hansen Medical says its 3rd-generation Sensei X2 robot-assisted surgery device won an FDA nod for use in heart procedures.

Hansen Medical launches 3rd-gen Sensei surgical robot for stent procedures

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Hill-Rom hires energy exec Strobel for CFO | Personnel Moves

October 27, 2014 by Brad Perriello

Hill-Rom looks to the energy industry for its new CEO, Steven Strobel, lured from retail energy services company BlueStar Energy.

Hill-Rom hires energy exec Strobel for CFO | Personnel Moves

Hill-Rom Holdings (NYSE:HRC) said it looked to the energy industry to replace James Saccaro as CFO, naming BlueStar Energy's former CFO Steven Strobel to the position.

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Hansen Medical logs 1st U.S. robotic fibroid embolization

October 21, 2014 by Alexander Soule

Hansen Medical says it's Magellan robot-assisted surgery device was used in the 1st robotic fibroid embolization procedure in the U.S.

Hansen Medical logs 1st robotic fibroid embolization

Hansen Medical (NSDQ:HNSN) said its Magellan surgical robotics system was used in the 1st robotic fibroid embolization performed in the U.S.

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Hansen Medical doubles Q2 sales, draws $23M from warrants

August 1, 2014 by Brad Perriello

Hansen Medical says it more than doubled sales of it robot-assisted surgery systems during the 2nd quarter and exercised warrants worth some $23 million.

Hansen Medical doubles Q2 sales, draws $23M from warrants

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