Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Flowonix warns on MRI risk for Promectra implantable pump
Flowonix Medical issued an urgent field safety notice late last month warning of risks associated with magnetic resonance imaging procedures for patients with its Prometra implantable pump, which include possible drug overdoses.
Flowonix said it has “become aware” of issues arising from patients undergoing MRI procedures without following labelled MR conditions. Read more
4. Baxter jumps on classic Q2 beat-n-raise
Baxter posted a classic beat-and-raise 2nd quarter today, handily topping expectations on Wall Street and boosting its outlook for the rest of the year and sending its share price up in early trading.
The Chicago-area healthcare giant logged profits of $130 million, or 24¢ per share, on sales of $2.56 billion for the 3 months ended Sept. 30, for a dramatic 12,900% bottom-line gain on sales growth of 2.9% compared with Q3 2015. Read more
3. There’s no quit in Abbott whistleblower Colquitt
The whistleblower behind a decade-old lawsuit against Abbott won’t say die, asking a federal appeals court last week to order a new trial after a jury shot him down earlier this year.
Former Guidant sales rep Kevin Colquitt sued Abbott, Johnson & Johnson and Boston Scientific in 2006 for $219.4 million, claiming that they marketed the use of biliary stents to treat peripheral artery disease. (The magistrate overseeing the lawsuit, Judge Barbara Lynn of the U.S. District Court for Northern Texas, later let J&J and Boston Scientific off the hook.) Read more
2. Zimmer Biomet wins 2nd NexGen Flex bellwether
Zimmer Biomet last week won the 2nd bellwether lawsuit brought over its NexGen Flex knee replacement, after a federal judge in Illinois found that the plaintiff failed to prove that a design defect caused his implant to fail.
The FDA in 2007 cleared the NexGen Flex implant, designed to provide more flexibility than other knee replacement devices. Plaintiffs in the thousands of product liability lawsuits filed since then allege that the device can’t withstand the extra flexion, despite the Warsaw, Ind.-based company’s marketing claims. The plaintiffs also allege that a design flaw makes the device more prone to premature loosening requiring revision procedures. Read more
1. FDA launches public whistleblower site for ‘regulatory misconduct’
The FDA last week launched a whistleblower website designed to let whistleblowers let the federal safety watchdog know about allegations of “regulatory misconduct” on the part of medical device makers.
The online “Allegations of Regulatory Misconduct Form” allows anyone to report an allegation of regulatory misconduct to the FDA, the agency said Oct. 21. Read more
The post MassDevice.com +5 | The top 5 medtech stories for October 25, 2016 appeared first on MassDevice.
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