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 […]
How Reggie Groves reinvented Medtronic’s atrial fibrillation biz
Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview: When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much […]
FDA clears Innovative Health to reprocess major manufacturers’ catheters
Innovative Health said it has nabbed FDA clearances to reprocess diagnostic catheters made by St. Jude Medical, Medtronic and Biosense Webster. The catheters include St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav. Innovative Health said it is the first in the industry to receive clearances to reprocess the Advisor and the Decanav, […]
Insider trading ring draws another guilty plea
Federal prosecutors last week drew another guilty plea in an insider trading case based on alleged tips from a Bank of America employee on pending corporate transactions, including Abbott‘s (NYSE:ABT) $25 billion acquisition of St. Jude Medical. In August 2017, U.S. authorities accused seven individuals of reaping more than $5 million in illicit profits based on tips […]
Abbott’s St. Jude Medical must face negligence suit over Riata leads
Abbott (NYSE:ABT) subsidiary St. Jude Medical must face a negligence lawsuit brought over its recalled Riata defibrillator leads after a federal judge ruled that the case is not pre-empted by federal rules. Plaintiff Kristen Bull was implanted with a St. Jude implantable cardioverter defibrillator using Riata leads in November 2010, just a month before the company pulled the […]
Abbott escapes payer’s lawsuit over St. Jude Medical CRM batteries
Abbott (NYSE:ABT) this week escaped a purported class action lawsuit brought by a third-party payer over defective batteries used in subsidiary St. Jude Medical‘s cardiac rhythm management devices. Plaintiff ASEA/AFSCME Local 52 Health Benefits Trust brought the suit last September on behalf of third-party payers, alleging in the U.S. District Court for Northern Illinois that Abbott and St. […]
Abbott’s St. Jude, Biotronik log appeals court win in spat with patent troll
Medical device makers this week won a victory in an ongoing spat with a patent troll. A federal appeals court yesterday upheld a ruling invalidating a patent from holding company Atlas IP which it had asserted against medical device makers Biotronik, Abbott (NYSE:ABT) subsidiary St. Jude Medical and Pacesetter. The US Court of Appeals for the Federal […]
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