Medical Devices: Page 52


  • Medtronic's Stacey Churchwell is pictured wearing a blue suit jacket and white shirt.
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    Permission granted by Medtronic
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    Opinion

    Friend, not foe: How AI will revolutionize patient care

    Artificial intelligence should be embraced to help streamline data and tackle clinician burnout, says Medtronic’s Stacey Churchwell.

    By Stacey Churchwell • Oct. 2, 2023
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    Permission granted by AdvaMed
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    Accuray’s Suzanne Winter to lead AdvaMed radiotherapy sector

    Winter, the CEO of Accuray, succeeds Baxter’s Chris Toth as chair of the trade group’s radiation therapy sector.

    By Oct. 2, 2023
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline
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    Permission granted by Boston Scientific
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
  • A medtronic mobile lab with a mockup operating room for training
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    Courtesy of https://news.medtronic.com/newsroom-medtronic-hits-the-road-mobile-labs
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    Medtronic in exclusive talks for $7B sale of units to private equity: report

    The Carlyle Group is leading the race to buy Medtronic’s connected patient monitoring and respiratory care operations, Reuters reported.

    By Oct. 2, 2023
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    Permission granted by Esper
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    Sponsored by Esper

    Healthtech companies dealing with complex device fleets, new report finds

    Four ways HealthTech companies are using modern solutions to manage their mission-critical devices.

    Oct. 2, 2023
  • Laboratory research, dropping liquid to test tubes, Blue tone
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    Permission granted by Veeva Systems
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    FDA to regulate lab-developed tests under proposed rule

    The tests have come under scrutiny by the agency and lawmakers, but the FDA is still likely to face pushback on the changes.

    By Sept. 29, 2023
  • A grey reader shows a blood glucose reading, next to a white circular device
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    Permission granted by Abbott
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    Abbott data suggests GLP-1 drugs a ‘modest accelerator’ for CGMs: analysts

    The analysis of U.S. insurance claims found people on GLP-1 therapy wear their FreeStyle Libre sensors more.

    By Sept. 29, 2023
  • A U.S. flag is shown in the foreground waving outside with the dome of the U.S. Capitol shown in the background.
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    Samuel Corum via Getty Images
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    As government shutdown looms, medical device reviews expected to continue

    The FDA could furlough nearly a fifth of its staff by Sunday if Congress doesn’t reach a funding agreement. 

    By Sept. 28, 2023
  • A surgeon wearing blue gloves demonstrates using the Galen device.
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    Retrieved from Galen Robotics on September 27, 2023
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    Galen robot gets FDA de novo clearance for ENT surgeries

    The startup affiliated with Johns Hopkins University said it is opening a bridge round for its series B financing as it targets more applications for the robotic surgery assistant.

    By Sept. 28, 2023
  • A photo of Carmat's artificial heart device.
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    Courtesy of Carmat
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    Artificial heart maker’s cash runway shrinks to 1 month after supply woes hurt sales

    France’s Carmat expects revenues of up to 6 million euros in the second half of the year but needs to secure financing to avoid running out of money.

    By Sept. 28, 2023
  • A person wearing a blue glove holds a test tube with red liquid
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    Getty Images
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    Harbinger Health raises $140M to study blood-based cancer screening test

    The test developer will use the series B funding to complete a 10,000-subject clinical trial ahead of a planned launch in 2025.

    By Sept. 28, 2023
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    Getty Images
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    Siemens Healthineers buys Aspekt to bolster radiation oncology services

    The company’s Varian unit sees Aspekt as complementary to its Advanced Oncology Solutions business, which provides professional and clinical services.

    By Sept. 27, 2023
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    Getty Images
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    FDA finalizes guidance on cybersecurity for medical devices

    Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October. 

    By Sept. 27, 2023
  • A sign saying "Zeus" is is in front of a tower that says "Arden Hills"
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    Courtesy of Zeus
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    Device component-maker Zeus exploring sale: Reuters

    The firm, which manufacturers catheters and other medical components, could be valued at $4 billion or more, according to the report.

    By Sept. 26, 2023
  • Edwards Lifesciences says it was target of surprise EU antitrust inspection

    The European Commission announced the action last week without naming the cardiovascular device company.

    By Sept. 26, 2023
  • Vicarious Surgical
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    Permission granted by Vicarious Surgical
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    Surgical robot maker Vicarious faces possible NYSE delisting

    The company’s shares could be delisted from the New York Stock Exchange if the price does not rise above $1.

    By Sept. 26, 2023
  • An illustration of two lungs on a scientific background colored orange.
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    Getty Images
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    Clinical data from Boston Scientific and rivals could reshape pulmonary embolism market: analysts

    It is not yet clear how different approaches would benefit specific patients, creating uncertainty about which businesses will profit from the shift.

    By Sept. 26, 2023
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    CFO Editorial Staff
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    Enovis inks $847M acquisition to boost orthopedic reconstruction business

    A Wells Fargo analyst said the deal was “much larger than what we were expecting.”

    By Sept. 26, 2023
  • A photo of a sign showing the Food and Drug Administration logo
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    Sarah Silbiger via Getty Images
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    Intarcia’s diabetes drug-device combo voted down again by FDA panel

    The 19-member advisory committee unanimously voted against Intarcia in the review, citing cardiovascular and kidney safety concerns.

    By Gwendolyn Wu • Sept. 25, 2023
  • University of Nebraska professor Shane Farritor operates the MIRA surgical robot in a lab on the Nebraska campus.
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    Retrieved from University of Nebraska-Lincoln on September 25, 2023
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    Developer of miniaturized surgical robot extends funding round

    Virtual Incision, whose surgical robot is headed to the International Space Station next year, raised $30 million in an extension of its series C round.

    By Sept. 25, 2023
  • A white, rectangular sticker device is in front of a blue, pen-shaped device.
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    Courtesy of Medtronic
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    Medtronic receives CE mark for CGM sensor, boosting challenge to Abbott and Dexcom

    Medtronic has made the sensor smaller and eliminated the need for fingersticks to calibrate the device, bringing a challenger to market leaders Abbott and Dexcom. 

    By Sept. 25, 2023
  • A photo of a sign showing the Food and Drug Administration logo
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    Sarah Silbiger via Getty Images
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    FDA shares draft medical device harmonization plan to meet MDUFA V goal

    The FDA outlined deadlines for actions it will take, including creating a mechanism for working with regulatory partners.

    By Sept. 25, 2023
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    Shutterstock/sfam_photo

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    Sponsored by Shyft Global Services

    How can medical device OEMs support the circular economy?

    Discover how medical device OEMs can be part of the circular economy for a more sustainable future.

    Sept. 25, 2023
  • A patient and clinician in front of a Hologic breast imaging device
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    Courtesy of Hologic
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    Hologic allies with Bayer to support uptake of contrast-enhanced mammography

    The companies will provide a product package and training intended to support adoption of the imaging technique.

    By Sept. 22, 2023
  • M&A
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    Getty Images
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    Is bigger better? McKinsey predicts the return of large medtech mergers

    The analysts argue that pressure to improve margins and become the partner of choice to hospitals favors large deals.

    By Sept. 22, 2023
  • Boston Scientific's Farapulse pulsed field ablation PFA generator and catheter
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    Permission granted by Boston Scientific
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    Boston Scientific expects ‘dramatic shift’ to pulsed field ablation to fuel fast growth through 2026

    Management predicts PFA’s share of the AFib ablation market will climb from less than 5% now to as much as 80% in five years.

    By Sept. 22, 2023