Medical Devices

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    Permission granted by Abbott
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    Q&A

    Abbott’s new diabetes leader on latest sensors, partnerships and Type 2 coverage

    Ahead of the American Diabetes Association’s Scientific Sessions, Chris Scoggins said Abbott’s ambition is to be the most broadly connected diabetes tech company.

    By • June 12, 2025
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic recalls ventilators linked to 2 serious injuries, 1 death

    The recall comes more than one year after Medtronic announced it would exit the ventilator market.

    By • June 12, 2025
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    Anna Moneymaker via Getty Images
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    Trump says tariff deal with China is ‘done’

    The proposed agreement, pending approval from both countries, sets 55% tariffs on imports from China and a 10% rate on U.S. products, the president said Wednesday.

    By Philip Neuffer • June 11, 2025
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    Sarah Silbiger via Getty Images
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    FDA schedules first public MDUFA VI meeting ahead of negotiations

    Officials want to know what current features should be reduced or stopped to “ensure the continued efficiency and effectiveness of the medical device review process.”

    By • June 11, 2025
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    Courtesy of Tandem Diabetes Care
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    Tandem, Abbott team on insulin delivery with glucose-ketone sensor

    Tandem will integrate its insulin delivery systems with a new dual glucose-ketone sensor being developed by Abbott.

    By • June 10, 2025
  • Elekta CEO Jakob Just-Bomholt is pictured in an open-collar white shirt and Navy blue blazer.
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    Courtesy of Elekta
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    Elekta appoints Jakob Just-Bomholt as CEO

    The company cited Just-Bomholt’s strategic leadership, international experience and ability to drive profitable growth and global expansion as evidence he is the right person for the job.

    By • June 10, 2025
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    Permission granted by Medtronic
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    Medtronic names Kate Benedict president of acute care and monitoring

    Medtronic had planned to spin out the two units before consolidating them into one segment last year.

    By • June 10, 2025
  • A view of Baxter International's production facility in the state of North-Rhine Wetsphalia on January 15, 2021 in Halle, Germany.
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    Sascha Schuermann via Getty Images
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    Baxter recalls Novum pump linked to 1 serious injury

    The company has asked users to monitor patients frequently to ensure the appropriate infusion is being delivered.

    By • Updated June 11, 2025
  • A wall bearing the Johnson & Johnson logo is seen outside of an office building.
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    Courtesy of Johnson & Johnson
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    Judge rules J&J unit must pay $442M in antitrust case

    A federal judge awarded triple damages after a jury found Biosense Webster withheld support to hospitals that bought reprocessed catheters.

    By • June 9, 2025
  • Blue and yellow flags bearing the European Commission logo fly in front of a building.
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    Carl Court via Getty Images
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    EU plan would limit Chinese device makers in Europe

    The move comes after a recent investigation found Chinese government procurement practices discriminate against EU companies in China’s domestic market.

    By • June 6, 2025
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic removes tracheostomy tubes due to dislodging risk

    If the tube moves out of place, it could prevent a patient from breathing or block the airway. A Medtronic spokesperson said patient harm was reported in some cases.

    By • June 6, 2025
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    Stock via Getty Images
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    Owens & Minor spikes $1.36B Rotech buyout over regulatory barriers

    The companies scrapped the merger because securing FTC clearance “proved unviable in terms of time, expense and opportunity.”

    By • June 6, 2025
  • Outset Medical's Tablo Hemodialysis System.
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    Courtesy of Outset Medical
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    Outset Medical appoints Renee Gaeta as CFO

    Gaeta’s last role was a brief stint at Shockwave, which named her CFO two months before accepting J&J’s $13.1 billion takeover offer.

    By • June 5, 2025
  • Elon Musk speaks at a Neuralink event with surgical robot in the foreground.
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    "Elon Musk and the Neuralink Future" by Steve Jurvetson is licensed under CC BY 2.0
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    Neuralink raises $650M to help expand patient access

    Elon Musk’s brain implant startup said five people with severe paralysis are now using the device.

    By • June 4, 2025
  • A sign for the FDA is displayed outside the agency's headquarters in Silver Spring, Maryland.
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    Sarah Silbiger via Getty Images
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    Smiths Medical recalls infusion pumps over 3 problems

    Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm. 

    By • June 4, 2025
  • A wall bearing the Johnson & Johnson logo is seen outside of an office building.
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    Courtesy of Johnson & Johnson
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    J&J may take a softer tariff hit after US-China pause, CFO says

    Joseph Wolk told an investor conference that the company’s tariff estimate is a “moving target” as trade talks continue with China and Europe and Section 232 investigations are ongoing.

    By • June 4, 2025
  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
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    Thomas Andreas via Getty Images
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    Clairity receives FDA OK for breast cancer risk prediction tool

    The startup received de novo authorization for the AI tool, the first of its kind that analyzes mammogram images to predict breast cancer risk over five years.

    By • June 3, 2025
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    Permission granted by Nvidia
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    Q&A

    Nvidia’s David Niewolny on the future of AI in medical devices

    Nvidia, which is already working with J&J and Medtronic, plans to partner with medtech companies to build platforms for AI-enabled robotics, imaging and other features.

    By • June 2, 2025
  • A group of people cheering inside the Nasdaq building, standing behind a podium.
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    Permission granted by Beta Bionics
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    Q&A

    Beta Bionics CEO, CFO on how to take a company public

    CEO Sean Saint and CFO Stephen Feider spoke about what’s different now that the company is public and the long journey of pursuing an IPO.

    By • June 2, 2025
  • The logo of the Food and Drug Administration is seen in a close-up view of the agency's website.
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    Mario Guti via Getty Images
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    Bivacor wins FDA breakthrough nod for titanium total artificial heart

    The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically suitable for longer-term use.

    By • June 2, 2025
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    ventdusud via Getty Images
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    The medtech IPO window is finally open. Or is it?

    After a three-year IPO drought, the industry is questioning whether the window for medtech public offerings is open following a small burst of activity.

    By • Updated June 3, 2025
  • Photo of Michael F. Mahoney, CEO of Boston Scientific.
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    Courtesy of Boston Scientific
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    Boston Scientific plans changes to expected $200M tariff hit as situation shifts

    The company also shared more details of its exit from the TAVR market and the impact of FDA layoffs on product review times.

    By • May 29, 2025
  • 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 ends TAVR sales; J&J shares Monarch robot data

    Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory requirements.”

    By • May 28, 2025
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    Sarah Silbiger via Getty Images
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    FDA finds Chinese lab copied or falsified data, endangering patients

    The FDA said the findings raise doubts about the reliability and viability of premarket submissions based on the company’s data.

    By • May 28, 2025
  • The white Abbott Tendyne mitral valve is shown against a bright pink background.
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    Permission granted by Abbott
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    Abbott wins FDA approval for mitral valve replacement device, teeing up Edwards competition

    Abbott said the Tendyne system addresses a significant unmet need in cardiac care, providing an option for patients ineligible for open heart surgery and whose valves cannot be successfully repaired with MitraClip.

    By • May 28, 2025