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Medical device

26 die after attempting to replace Abbott's blood pump controller themselves

At least 26 advanced heart failure patients have died and 19 have been injured by attempting to change the controller on Abbott Laboratories’ HeartMate II blood pumps themselves at home. The manufacturer released new software and alarm guides concerning almost 29,000 devices to doctors on 30 March, after 70 reports of malfunctions following an unsuccessful controller replacement.

Medical device user fees to increase 68% for 2018 to 2022

The Food and Drug Administration has reached an agreement with the medical device industry and laboratory community on proposed recommendations for the fourth reauthorisation of a medical device user fee programme. Under this new agreement, the FDA is authorised to collect $999.5 million in user fees plus inflation over five years, a 68% increase from the $595 million in 2012.

Abbott to purchase St Jude Medical in $25 billion deal

Abbott (NYSE: ABT) has announced an agreement to purchase device manufacturer, St Jude Medical, in a deal worth $25 billion.

Under the terms of the deal, St Jude Medical shareholders will receive $46.75 in cash and 0.8708 shares of Abbot common stock, representing a total of $85 per share.

St Jude Medical boasts strong offerings in heart failure devices, atrial fibrillation and cardiac rhythm management and will complement Abbott’s positions in coronary intervention and transcatheter mitral repair.

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Implementing Medical Device Complaint Handling Systems

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