Medical Devices: Page 2

  • A headshot of Mojdeh Paul against with a window and white wall in the background.
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    Courtesy of Integra LifeSciences Holdings Corporation
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    Integra Lifesciences names Mojdeh Poul as CEO

    Poul will take over the company in January after spending 11 years with 3M and working at Medtronic and Boston Scientific.

    By • Nov. 5, 2024
  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Boston Scientific continues M&A run with Cortex buy

    Cortex adds to Boston Scientific’s electrophysiology portfolio amid treatment shifts in the space driven by new pulsed field ablation devices.

    By • Nov. 4, 2024
  • Front sign of FDA building Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
  • A doctor puts a pulse oximeter on a patient's finger
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    Wavebreakmedia via Getty Images
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    Medtronic settles pulse oximetry lawsuit alleging inaccuracies

    Roots Community Health has sued 12 other firms, including GE Healthcare, CVS and Walgreens, and called for manufacturers and the FDA to ensure the devices work for everyone.

    By • Nov. 4, 2024
  • Brain scans
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    iStock via Getty Images
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    Zimmer licenses NeuroOne brain ablation system

    NeuroOne will get $3 million upfront for an exclusive license to distribute its radiofrequency ablation system designed to treat neurological disorders such as epilepsy and Parkinson's disease.

    By • Nov. 4, 2024
  • Professional photo of Larry Jones
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    Permission granted by Johnson & Johnson
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    J&J Medtech CIO Larry Jones resigns

    Jones, who has led connectivity solutions for J&J’s surgical robots, announced his departure on LinkedIn.

    By • Updated Nov. 1, 2024
  • iRhythm's Zio AT cardiac monitor is shown against a white background.
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    Retrieved from iRhythm on October 22, 2024
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    FDA clears iRhythm’s second 510(k) in response to warning letter

    However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation efforts are further along.

    By • Nov. 1, 2024
  • The European Union flag.
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    artJazz via Getty Images
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    EU posts guidance on ethylene oxide in device sterilization

    The document clarifies that EtO falls within the scope of the Medical Device Regulation and the In Vitro Diagnostic Regulation.

    By • Nov. 1, 2024
  • A view of the Edwards Lifesciences headquarters building with three people walking in front.
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    Courtesy of Edwards Lifesciences
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    Edwards, Medtronic and Inari share trial data at TCT conference

    The three medtech firms unveiled new data this week during TCT 2024 in Washington, D.C. Here’s what the results mean for the companies and their device markets.

    By • Oct. 31, 2024
  • Boston Scientific's Acurate neo2 TAVR device is shown close up against a white background.
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    Courtesy of Boston Scientific
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    Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study

    Analysts said the findings complicate the outlook for a U.S. launch of Boston Scientific's aortic valve replacement device.

    By • Oct. 31, 2024
  • Professional photo of Ivan Tornos
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    Permission granted by Zimmer Biomet
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    Stryker, Zimmer outline different M&A strategies

    Stryker CEO Kevin Lobo told investors M&A will be the “number one use of our cash going forward,” while Zimmer Biomet CEO Ivan Tornos emphasized internal product development for growth.

    By • Oct. 30, 2024
  • The exterior of a U.S. Bankruptcy Courthouse.
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    GussWilder for iStock via Getty Images
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    Exactech files for Chapter 11, agrees to investor buyout

    The filing follows Exactech’s failure to settle product liability claims from about 2,600 patients in response to recalls of orthopedic devices.

    By • Oct. 30, 2024
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    Edwards Lifesciences
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    Edwards data show benefit of early TAVR over ‘watchful waiting’

    Study author Philippe Genereux said the trial data “shatter 60 years of ingrained belief on the treatment for severe aortic stenosis.”

    By • Oct. 29, 2024
  • An illustration of a heart bump inserted into a heart against a blue background.
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    Courtesy of Abiomed
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    J&J to seek FDA approval after small-bore Impella heart pump hits trial goal

    The company has predicted the narrower Impella ECP will be easier to insert and implant, as well as enable the use of small bore access and closure techniques.

    By • Oct. 29, 2024
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific to close Silk Road Medical headquarters, lay off 138 people

    Following its acquisition of Silk Road in September, Boston Scientific said it plans to consolidate the company’s work in Minnesota.

    By • Oct. 28, 2024
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips cuts sales forecast after ‘significant deterioration’ in China

    CEO Roy Jakobs expects the slump to continue into 2025, driven by China’s anti-corruption measures.

    By • Oct. 28, 2024
  • A person holds a clear, spiral shaped device with metal dots.
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    Retrieved from Hologic on May 23, 2024
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    FDA advises clinicians to stop using Hologic radiographic markers

    Hologic has recalled the Biozorb devices after 188 reports of adverse events in patients who received the implants in breast tissue.

    By • Oct. 28, 2024
  • Professional photo of Teri Lawver
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    Permission granted by Dexcom
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    Dexcom chief commercial officer to retire

    Teri Lawver is leaving the diabetes tech company during a challenging time, with sales slowing after a workforce restructuring.

    By • Oct. 25, 2024
  • An image of Edwards Lifesciences' Irvine, California, campus at dusk.
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    Courtesy of Edwards Lifesciences
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    Edwards’ TAVR sales faced ongoing hospital constraints in Q3

    Hurt by a slowdown in procedures for its heart valve replacement devices, Edwards said it is working with hospitals to manage workflow challenges.

    By • Oct. 25, 2024
  • A person wearing gloves hangs a clear bag with fluid on a metal hook.
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    Bevan Goldswain via Getty Images
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    Baxter to restart high-throughput IV solutions manufacturing line

    Baxter still does not have a timeline for fully restoring production at the North Carolina facility, which was hit by Hurricane Helene.

    By • Oct. 25, 2024
  • Medtronic's Affera all-in-one ablation system
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    Courtesy of Medtronic
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    Medtronic wins FDA approval for Affera mapping and ablation system

    Affera combines mapping technology with a catheter capable of performing radiofrequency and pulsed field ablation.

    By • Oct. 25, 2024
  • European Union flags are pictured waving outside the European Commission building.
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    Carl Court via Getty Images
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    European Parliament calls for proposals to reform MDR and IVDR by end of Q1

    Parliament asked the European Commission to publish acts that address the “most pressing challenges and bottlenecks” of the regulations and propose the “systematic revision” of the legislation.

    By • Oct. 24, 2024
  • Six people sit on a curved couch around a table.
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    Elise Reuter/MedTech Dive
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    The Medtech Conference

    Medtech Conference recap: New CDRH leader details approach; AI and LDTs in focus

    Catch up on our recent coverage of Advamed’s The Medtech Conference.

    By • Oct. 23, 2024
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific boosts PFA expectations, citing rapid Farapulse adoption

    Demand for the pulsed field ablation device drove the company’s electrophysiology sales up 177% in the third quarter compared to a year ago.

    By • Oct. 23, 2024
  • Hologic's 3Dimensions mammography system.
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    Courtesy of Hologic
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    Hologic to lay off 86 people in closure of Connecticut facility

    The company committed to closing the facility, which makes breast health products, in late 2021 and gave most employees the option to relocate to other sites.

    By • Oct. 23, 2024
  • iRhythm's Zio AT cardiac monitor is shown against a white background.
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    Retrieved from iRhythm on October 22, 2024
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    iRhythm’s Zio AT design changes win FDA clearance

    The agency cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.

    By • Oct. 23, 2024