Abbott is recalling certain pacemakers that may short circuit because they can allow moisture inside, according to the FDA. The recall covers 61,973 Assurity and Endurity pacemakers manufactured by St. Jude Medical and distributed from April 2015 to February 2019. (Abbott acquired St. Jude in 2017). A small number of devices from that time frame […]
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Abbott’s St. Jude Medical wins patent spat over catheterization method
St. Jude Medical, now part of Abbott, has won a patent dispute over a method for using a double catheter in heart failure patients. Niazi Licensing’s patent, issued in 2003 for the double catheter system, describes it as better suited for “use in the coronary sinus, especially in patients suffering from congestive heart failure,” according […]
Miles White’s fearless strategy for growing Abbott
With strong leadership and a taste for risk-taking, outgoing CEO Miles White left no stone unturned as he grew Abbott into one of the world’s largest medical device companies. Few medical device companies have seen the growth and transformation that Abbott (NYSE:ABT) has seen under the leadership of Miles White. During his two decades as […]
JAMA editorial slams FDA over adverse-event reporting
This article has been updated with comments from the FDA. A recent JAMA Internal Medicine editorial takes another swipe at the FDA for delays in improving its medical device adverse-event reporting. Journal editor Dr. Rita Redberg and Dr. James Salazar, both of Department of Medicine, University of California, San Francisco, note several instances in which […]
SEC settles insider trading cases
The U.S. Securities & Exchange Commission said this week that it settled the case against the final five defendants in an insider trading scheme involving involving large corporate mergers. In August 2017, U.S. authorities accused seven individuals of reaping more than $5 million in illicit profits based on tips from Daniel Rivas, whose work at Bank […]
Humana sues Abbott’s St. Jude Medical over CRM batteries
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 […]
Innovative Health lands another catheter reprocessing clearance
Innovative Health said today that it has received FDA clearance to reprocess the Biosense Webster PentaRay Nav eco high-density mapping catheter for reuse. The clearance is the latest allowing Scottsdale, Ariz.-based Innovative Health to reprocess catheters. The FDA cleared it in 2018 to reprocess St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s […]
Final defendant sentenced in insider trading case
Federal prosecutors have wrapped up an insider trading case based on alleged tips from a Bank of America consultant on pending corporate transactions, including Abbott‘s (NYSE:ABT) $25 billion acquisition of St. Jude Medical. Rodolfo Sablon, 39, of Miami, Fla., was sentenced Friday to six months in prison for his role in the insider trading scheme based […]
Medtronic touts stroke data for HeartWare LVAD
A retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump. The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance […]
Study finds fault with ICD leads that Abbott inherited from St. Jude Medical
A review of FDA adverse event reports has revealed that some Abbott (NYSE:ABT) implantable cardioverter defibrillator (ICD) leads were much more likely than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches (IBR). Researchers at the Minneapolis Heart Institute Foundation combed through the FDA MAUDE database from 2008 to 2018 for reports […]
What should the Mann Foundation do next?
Dr. Robert Greenberg, the Mann Foundation’s new executive chairman, has ideas about where to take one of medtech’s top research and development outfits. He explained more at DeviceTalks West in December. The new executive chairman of the Alfred E. Mann Foundation for Scientific Research sees the foundation continuing its mission of developing devices for unmet medical needs. The foundation […]
