Abbott’s (NYSE:ABT) MitraClip heart valve device may secure Medicare coverage for an additional procedure. The Center for Medicare and Medicaid Services (CMS) announced yesterday that it will study whether to extend coverage of the MitraClip transcatheter mitral valve repair (TMVR) device in cases of secondary mitral regurgitation, which results from left ventricular dysfunction. Medicare already pays […]
Ex-Oriole DeCinces draws time served on insider trading conviction
A federal judge in California reportedly sentenced former professional baseball player Doug DeCinces to time served this week after his conviction on insider trading charges related to the $2.8 billion acquisition of Advanced Medical Optics by Abbott (NYSE:ABT) in 2009. Federal prosecutors in 2014 accused ex-AMO CEO James Mazzo of tipping former Orioles and Angels player […]
FDA slaps Abbott ICD recall with Class I label
The FDA has labeled a recent Abbott (NYSE:ABT) recall of Ellipse implantable cardioverter defibrillators (ICDs) as the most serious type, which could result in patient death. The company began the recall in June, citing damaged wires in 204 Ellipse pacemakers distributed globally. Today’s FDA announcement said that a faulty manufacturing process had left the Ellipse […]
Humana sues Abbott’s St. Jude Medical over CRM batter
Humana (NYSE:HUM) leveled a lawsuit against Abbott (NYSE:ABT) subsidiary St. Jude Medical seeking to recoup payments it made for cardiac rhythm management devices that were later recalled due to a battery issue. In October 2016 St. Jude publicly revealed the risk that the lithium-based batteries used in its implantable cardioverter defibrillators and cardiac resynchronization therapy […]
The 17 most innovative medical devices of 2019
The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
Abbott gains on Q2 earnings beat, raised outlook
Abbott (NYSE:ABT) shares gained today in pre-market trading after the healthcare giant beat the second-quarter consensus earnings forecast and raised its outlook on the rest of the year. Abbott Park, Ill.-based Abbott posted profits of $1.0 billion, or 56¢ per share, on sales of $7.98 billion for the three months ended June 30, for a […]
Abbott wins FDA approval for its fourth-generation MitraClip
Abbott (NYSE:ABT) announced today that U.S. FDA has approved the MitraClip G4, the most advanced version yet of the company’s transcatheter heart valve repair device to treat mitral regurgitation. Abbott expanded the number of clip sizes to four for the MitraClip G4, including clips with a wider grasping area, in order to expand the treatment options […]
Abbott recalls select Ellipse ICDs due to damaged wires
Abbott (NYSE:ABT) began voluntarily recalling 204 Ellipse implantable cardioverter defibrillators in June to prevent the use of devices that may have a vulnerability in the electronic circuitry due to damaged wires, according to a recently-filed urgent field safety notice. The company stressed that it has not received any product performance complaints or adverse patient events related […]
Survey: Few adults know signs of heart failure
Only one in five adults can accurately recognize the signs and symptoms of heart failure, according to a new survey commissioned by Abbott (NYSE:ABT). The survey of more than 3,000 Americans revealed a significant gap in awareness of what heart failure is and an understanding of how the disease can be managed. More than six […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
Report: Healthcare CEO pay balloons to $2.6B, quality of care not a factor in bonuses
Healthcare chief execs at 177 top companies collectively saw their compensation grow to $2.6 billion last year while quality of care and improvements to healthcare spending remained at most a marginal factor to their pay, according to an Axios analysis. Despite a focus on pharmaceutical CEOs, medical device company chief execs were five of the […]
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