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  • A sign for the Food And Drug Administration is seen
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    Sarah Silbiger via Getty Images
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    Device firms back latest MDUFA deal, while patients want more postmarket safety

    The latest agreement includes higher fees for overseas firms, hiring transparency requirements and greater use of real-world evidence.

    FDA
  • A white, rounded hourglass-shaped patch says "vitalconnect"
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    Courtesy of VitalConnect
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    IRhythm grows heart monitoring leadership with $288M VitalConnect buy

    Acquiring VitalConnect could unlock a $1 billion cardiac monitoring market that is only partly served by iRhythm’s existing devices.

    M&A
  • Healthcare information
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    Getty Images
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    Q&A

    When does it make sense to build software instead of buy? One health system’s answer.

    NYU Langone Health and Dana-Farber Cancer Institute built an oncology decision support tool to guide clinicians through treatment. Now, the institutions are commercializing the product so other health systems can use it too.

  • A Grail employee in white coat and blue gloves works with a blood sample.
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    Courtesy of Grail
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    FDA sets advisory panel for Galleri multicancer screening test

    Outside experts will convene in September to review Grail’s premarket approval application for the MCED blood test. Experts selected for the committee will be key to watch, an analyst said.

    FDA
  • Medtronic's Sphere-9 ablation catheter.
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    Courtesy of Medtronic
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    Medtronic gets CE mark for ablation to treat ventricular tachycardia

    Older ablation approaches for ventricular tachycardia have been suboptimal, Medtronic said. The company plans to bring a more effective treatment for the life-threatening heart condition.

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    Patrik Stollarz / Staff via Getty Images
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    Philips forms 6 patient monitoring partnerships

    By employing wearable devices to support patient monitoring between the hospital and home, Philips hopes to improve care continuity.

  • A portrait of George Murgatroyd.
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    Permission granted by Medtronic
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    Q&A

    Medtronic on the future of AI-assisted surgery

    Medtronic’s George Murgatroyd says an advanced computing platform that works with the company’s Hugo robot will power AI algorithms that can assist surgeons as they operate.

    AI
  • A sign for Zimmer Biomet is shown outside of the company's headquarters building.
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    Getty Images
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    Zimmer Biomet sales force revamp going better than expected, CEO says

    The restructuring, intended to give Zimmer Biomet a fully dedicated sales force, is expected to be complete by the end of 2027.