When Medtronic Inc. (NYSE:MDT) CEO Art Collins retired in 2007, there were at least two top candidates vying to replace him. One was Michael DeMane, the brash president of Medtronic's spine business whose aggressive pursuit of growth invited legal and regulatory scrutiny. The other was chief operating officer Bill Hawkins, a steady, stabilizing presence within Medtronic's senior leadership team.
From a strictly legal sense, Medtronic Inc. (NYSE:MDT) has closed the book on its Sprint Fidelis debacle. The Fridley, Minnesota, company won a landmark victory in the U.S. Supreme Court that effectively shields medical device makers from liability of Food and Drug Administration-approved devices. And in October, Medtronic said it would pay $268 million to settle all lawsuits relating to its Sprint Fidelis leads. But about 260,000 Sprint Fidelis leads have been implanted in patients in the United States, with 143,000 still active.
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
Medtronic Inc. (NYSE: MDT) said Thursday it will pay $260 million to settle all U.S. lawsuits relating to its faulty Sprint Fidelis defibrillator leads. In exchange, plaintiffs' lawyers agreed to dismiss related litigation nationwide.
The U.S. Appeals Court for the Eighth District shot down the appeal of a ruling dismissing a shareholders lawsuit against Medtronic Inc. (NYSE:MDT), saying the plaintiffs failed to prove the company deliberately concealed problems with its Sprint Fidelis leads.
In mid-May, Cameron Health Inc. struck media gold when the New York Times and the New England Journal of Medicine both gave prominent coverage to the company's efforts to develop the medical device industry's first subcutaneous implantable cardioverter defibrillator (ICD). Not bad for a relatively unknown startup in San Clemente, California. But a week earlier, Cameron struck managerial gold when it hired Warren Watson.
Medtronic Inc. (NYSE:MDT) is quietly working on plans to develop a pacemaker that can deliver electricity to the heart without wires. The company, based in Fridley, Minnesota, confirmed to MedCity News begin_of_the_skype_highlighting end_of_the_skype_highlighting that it's building a leadless pacemaker but offered no further details on the device, which reportedly can be implanted directly into the right ventricle.
Since he assumed his post in January, Dr. Jeffrey Shuren, the top Food and Drug Administration official on medical devices, has walked a delicate tightrope. He has worked hard to reassure a nervous industry that the FDA still values innovation, but has not promised anything specific. But listening to his remarks, an informal understanding seems […]
Medtronic Inc. (NYSE:MDT) is fielding a pair of lawsuits, one accusing it of product liability over its Sprint Fidelis implantable cardiac defibrillator leads and another alleging that it falsely marked some of its Endeavor stents with a pair of U.S. patents. The Minneapolis medical device monolith pulled the Sprint Fidelis leads from shelves worldwide in […]
As a journalist, I’m frequently beset with impulsive self-righteousness. Which is why I jumped the gun a bit this week. I wanted to attend the Med Tech Investment conference in Minneapolis this past week, specifically a speech by Dr. Dan Schultz, the former head of the Center for Devices and Radiological Health (CDRH) at the […]
The Food and Drug Administration, urged by Congress, has already taken a harder line on 510(k)s. Which makes it only a matter of time before the agency, wary of another Sprint Fidelis debacle, sets its sights on PMA supplements.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
