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 […]
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 […]
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 […]
Magistrate judge recommends dismissal of inventor doc’s suit against Abbott’s St. Jude Medical
A federal magistrate judge in Texas last week recommended dismissal for a lawsuit brought by a physician inventor against Abbott (NYSE:ABT) subsidiarySt. Jude Medical over transcatheter valve replacement technology. Dr. Robert Snyder, founder of Snyders Heart Valve, filed suits two years ago in the U.S. District Court for Eastern Texas, claiming that both St. Jude and cross-town rival […]
This medtech CEO led his company to a $200 million buyout
Guiding a company through a merger or an acquisition can test a CEO’s leadership skills. Here’s how NinePoint Medical CEO, Christopher von Jako, led his former medtech company, NeuroTherm, through a deal with St. Jude Medical. When Christopher von Jako assumed the corner office at NeuroTherm in 2013, the company had gone through two other […]
Abbott wins FDA nod for pediatric Masters Series mechanical heart valve
Abbott (NYSE:ABT) subsidiary St. Jude Medical won expanded FDA approval today for its Masters Series mechanical heart valve, now cleared in a 15mm size, which the FDA said is the smallest mechanical heart valve approved in the world. The company’s Masters series mechanical heart valve is a rotatable, bileaflet valve designed for implantation in the aortic or […]
7 medical devices combating the opioid crisis
Opioid-related deaths have become an epidemic in the U.S., garnering attention from the White House, the FDA and many other governmental bodies. From 2000 to 2014, nearly half a million Americans died from drug overdoses. In 2015, more than 50,000 people died from drug overdoses, and 33,000 were opioid-related. Prescription overdoses continue to cause more […]
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