Medical Devices: Page 10

  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images
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    Roche wins CE mark for its first CGM

    The clearance positions Roche to challenge Abbott and Dexcom for the European continuous glucose monitor market.

    By • Updated July 10, 2024
  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    Pulse drops 510(k) plan for PFA device after FDA requests clinical data

    Analysts said the AFib device is now unlikely to come to market before late 2026.

    By • July 9, 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 picture of a woman talking to a nurse on an MRI tomography machine at a hospital.
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    FG Trade Latin via Getty Images
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    Philips recall of imaging coils tied to 12 injuries

    Several models of coils used in MRI scanners were recalled due to the risk of overheating, which can cause serious burns.

    By • July 9, 2024
  • Masimo's Stork baby monitoring boot, smartphone app and camera are displayed.
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    Courtesy of Masimo
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    Masimo offered up to $950M for consumer business

    Final terms of the deal are still being discussed, and Masimo said it plans to negotiate a higher price.

    By • July 9, 2024
  • Close up of a machine with several tubes, some of which are red.
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    saengsuriya13 via Getty Images
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    Baxter considers sale of kidney care unit to PE firm: WSJ

    Carlyle Group could reportedly pay more than $4 billion for Baxter’s Vantive business.

    By • July 8, 2024
  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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    BD to close Ireland facility, putting 170 jobs at risk

    A company spokesperson said the decision follows a recent review and reflects a push to improve operational efficiency.

    By • July 8, 2024
  • A picture of Masimo's headquarters building.
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    Mario Tama / Staff via Getty Images
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    Masimo employees rally around CEO Kiani as proxy fight looms

    Hundreds of healthcare engineers have joined managers to support founder and CEO Joe Kiani as he battles an activist shareholder for control of the company.

    By • July 3, 2024
  • A closeup of an eye with light reflecting off of it.
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    Zorica Nastasic via Getty Images
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    Alcon buys Belkin Vision for $81M upfront

    Alcon will gain access to a laser treatment for glaucoma that it plans to sell in the U.S. by the end of the year.

    By • July 3, 2024
  • A picture of a woman suffering from chest pain sitting on sofa in living room at home.
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    Jajah-sireenut via Getty Images
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    Merit Medical pays Endogastric $105M for acid reflux treatment

    Merit expects the device to add around $30 million in annual sales.

    By • July 2, 2024
  • Five syringes side by side with different tips.
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    Retrieved from Cardinal Health on July 02, 2024
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    FDA continues crackdown on plastic syringes made in China

    The agency has issued import bans for four manufacturers, and multiple companies have recalled affected syringes. Check out MedTech Dive’s roundup of the news.

    By • July 2, 2024
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA to expand total product life cycle program

    Officials plan to start accepting radiological and ophthalmic medical devices into the program, designed to accelerate medtech innovation, in October.

    By • July 2, 2024
  • Masimo CEO Joe Kiani looks over the countryside
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    Courtesy of BusinessWire/Masimo
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    Masimo COO says he’ll resign if CEO Kiani is forced out

    Activist investor Politan Capital Management is attempting to remove longtime Masimo leader Joe Kiani, claiming the company lacks independent oversight.

    By • July 1, 2024
  • A sign with company logo in red on a white background at the entrance to Johnson & JOhnson medical device unit
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    Mario Tama/Getty via Getty Images
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    Medtech M&A may pick up after mixed start to 2024: analysts

    The annual number of medtech acquisitions is on course to slump to its lowest level since 2017, according to Needham.

    By • July 1, 2024
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    FDA walks back injury, death reports on recent Philips BiPAP recall

    The agency now says 10 injuries and seven deaths are associated with the problem. The updated numbers match figures shared by Philips and are significantly below the original report.

    By • Updated July 11, 2024
  • Nick Jonas, Dexcom
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    Courtesy of Dexcom, Nick Jonas Super Bowl kit
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    Dexcom to lay off 535 employees in California

    A company spokesperson said Dexcom is centralizing its U.S. manufacturing operations in Arizona and repurposing its San Diego facility.

    By • June 27, 2024
  • Professional photo of Karen Parkhill standing indoors in front of a pillar and stairs.
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    Courtesy of HP
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    Medtronic CFO Karen Parkhill leaving for HP

    Truist analysts wrote that “there could be some investor angst until a permanent successor is announced.”

    By • June 27, 2024
  • Patient's view of dentist holding two dental instruments.
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    Peter Macdiarmid via Getty Images
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    Zimvie mulls sale after takeover approaches: Bloomberg

    Zimvie is reportedly working with an adviser to assess its options after strategic investors and industry players showed interest in a deal.

    By • June 26, 2024
  • A person digs with a spade in a raised garden bed. They wear a gray sticker on their upper arm.
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    Courtesy of Dexcom
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    Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech.

    Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.

    By • June 26, 2024
  • An oversized pair of scissors looms over seven workers sitting in office chairs suspended by strings.
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    mathisworks via Getty Images
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    Beyond Air cut more than 20% of employees

    BTIG analysts said the company’s near-term cash needs, “disappointing sales results and lack of progress on profitability metrics” are concerning.

    By • June 26, 2024
  • Professional photo of Dev Kurdikar
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    Permission granted by Embecta
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    Embecta touts its insulin patch pump at ADA

    Embecta said its device, with a larger insulin reservoir, addresses an unmet need for people with Type 2 diabetes.

    By • June 25, 2024
  • A picture of a man looking at a diabetes tracking app on his phone.
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    Retrieved from Ascensia Diabetes Care on June 25, 2024
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    Senseonics tips 365-day CGM to double 2025 sales

    Senseonics is in talks with insulin pump manufacturers about integrating its implantable Eversense continuous glucose monitor with their devices.

    By • June 25, 2024
  • A person sits in front of a plate of food, holding a smartphone. They're wearing a patch on their left arm.
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    Courtesy of Insulet Corp.
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    Insulet seeks label expansion of Omnipod 5 for Type 2 diabetes

    At the American Diabetes Association meeting, Insulet shared study results showing improvements in blood glucose and quality of life.

    By • June 24, 2024
  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    Cardinal Health recalls procedure kits over plastic syringes made in China

    Cardinal listed more than 500 catalog numbers in its recall notice and told customers to remove and discard the syringes.

    By • June 24, 2024
  • Image shows a spinal medical device.
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    Courtesy of Orthofix
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    Orthofix’s president of global orthopedics resigns

    Kimberley Elting will end her eight-year stint at the company in July, continuing Orthofix's recent trend of executive turnover.

    By • June 24, 2024
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    Patrik Stollarz / Staff via Getty Images
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    Philips Respironics to end manufacturing at two Pennsylvania plants: report

    Philips said it would transition operations from the two sites to a third-party manufacturer. The plan will cut 300 jobs, according to the Pittsburgh Post-Gazette.

    By • June 21, 2024