Two events this week prompted investors to disproportionately reward and punish stocks of two medical technology companies: Edwards Lifesciences (NYSE:EW) and St. Jude Medical (NYSE:STJ). One piece of news was largely expected — a panel at the U.S. Food and Drug Administration gave a thumbs up to the expanded indication for Edwards Lifesciences’ SAPIEN transcatheter […]
Late Wednesday, a U.S. Food and Drug Administration panel recommended that Edwards Lifesciences (NYSE:EV) transcatheter aortic valve replacement procedure be approved for patients with high risk to the alternative open-heart surgery. Late last year, Edwards became the first company in the U.S. to win FDA approval for using the so-called TAVR procedure on patients with […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Anyone who is even slightly aware of the dynamics of the medical device industry knows that Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) are not exactly the best of friends. The Minnesota behemoth and its smaller California rival have engaged in bitter legal wrangling over intellectual property and patents. Especially with respect to the transcatheter aortic […]
The protracted battle over transcatheter heart valves between Medtronic Inc. (NYSE:MDT) and Edwards Lifesciences Inc. (NYSE:EW) will be decided in the streets rather than the courts.
Medtronic Inc. (NYSE:MDT) managed to find the silver lining in the dark cloud that is a $74 million patent infringement judgment against it when a federal judge denied an Edwards Lifesciences Inc. (NYSE:EW) move to bar U.S. manufacturing and sales of its CoreValve aortic valve replacement.
Edwards Lifesciences Corp. (NYSE:EW) revealed yesterday a U.S. Attorney’s Office for Central California subpoena for documents related to its 2006 heart monitor recall. The Irvine, California-based cardiac device maker said the court communication came “in connection with an investigation by the federal Food & Drug Administration,” and sought “records relating to the Vigilance I Monitor […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Edwards Lifesciences Corp. got a boost this week after the New England Journal of Medicine published a study showing that the company's catheter-delivered aortic valve replacement is much safer for elderly patients than standard treatments. Edwards and Fridley, Minnesota-based Medtronic (and other companies) are racing to get the first percutaneous heart valves to market.
Medtronic Inc. lost the latest round in a long-running legal dispute when a jury found that its CoreValve heart valve system infringes on patents held by Edwards Lifecsciences Inc. The case is far from over, however, as Medtronic said it would appeal the jury’s verdict, which awarded Edwards $74 million in damages. Edwards plans to […]
The FDA posted notice of a Class I recall of a hemodialysis system distributed by Baxter International Inc., warning that in extreme cases the machine's defect could result in serious injuries or death.