The Latest

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

    Updated Nov. 1, 2024
  • A person speaks at a podium.
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    Elise Reuter/MedTech Dive
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    Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.

    Patient advocates are hoping for change under new director Michelle Tarver, while industry groups look to build on former director Jeff Shuren’s leadership.

    FDA
  • A stage at HLTH 2024.
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    Emily Olsen/MedTech Dive
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    Deep Dive

    Tech companies pitch AI platforms for healthcare, outline plans for responsible rollout

    Google, Microsoft and GE Healthcare say they’ll power the next wave of AI advancement. But executives are split on how to offer the tools to providers responsibly — and whether all clinicians are equally ready for them.

  • 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.

  • 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.

  • 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.

  • 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.

  • The AI Pavilion at HLTH 2024 in Las Vegas.
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    Emily Olsen/MedTech Dive
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    Deep Dive

    AI could be a game changer, but healthcare needs to be ‘exceedingly careful’

    Artificial intelligence tools could help solve workforce challenges. Implementation, however, can be difficult, pushing organizations to consider less risky administrative and back-office tasks first.

    FDA
  • 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.”