Medical Devices


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    Elise Reuter/MedTech Dive
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    AdvaMed CEO Scott Whitaker pleads for tariff relief in Senate hearing

    Whitaker repeated a call for “zero-for-zero” reciprocal tariffs between the U.S. and its trade partners in testimony before a Senate Finance Committee panel on critical supply chains.

    By May 14, 2025
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    Sean Gallup/Getty Images via Getty Images
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    European Commission readies countermeasures to US tariffs

    The commission is taking steps to target roughly $107 billion worth of imports if it can’t make a tariff deal with the U.S.

    By Antone Gonsalves • May 14, 2025
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    Permission granted by Embecta
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    Embecta restructures again, outlines tariff costs

    The diabetes tech company announced a second restructuring after ending its insulin patch-pump program.

    By May 13, 2025
  • Vicarious Surgical plans to seek de novo clearance for its surgical robot.
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    Permission granted by Vicarious Surgical
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    Vicarious Surgical, UMass partner; SS Innovations targets de novo submission

    Vicarious Surgical and SS Innovations marked progress toward bringing their robotic surgery systems to the U.S. market. The companies are among a new generation of robot developers planning to challenge Intuitive Surgical.

    By May 13, 2025
  • A women looks at Teal Health's at-home self-collection cervical cancer screening kit while at a counter.
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    Retrieved from Teal Health on May 13, 2025
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    Teal wins FDA approval for at-home cervical cancer screening device

    The company plans to start shipping the device in June, starting in California and then expanding nationwide.

    By May 13, 2025
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    Courtesy of Roche
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    Roche plans $550M expansion of Indianapolis site to manufacture CGMs

    Roche Diagnostics plans to produce glucose monitors at the site within three years and prepare for future generations of its sensors.

    By May 12, 2025
  • Treasury Secretary Scott Bessent appears before the House Financial Services Committee on May 7, 2025, in Washington, D.C.
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    Pete Marovich via Getty Images
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    US, China agree to reduce tariff rates for 90 days

    By Wednesday, the two countries will charge 10% baseline duties during the period and remove certain retaliatory levies that pushed rates over 100%.

    By Philip Neuffer • May 12, 2025
  • President Donald Trump displays a chart showcasing coming tariff rates at the White House on April 2, 2025.
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    Chip Somodevilla via Getty Images
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    Earnings & Tariffs

    Solventum’s projected $100M tariff hit prevents earnings increase

    CEO Bryan Hanson said tariffs have given “a higher sense of urgency” to the company’s existing efforts to regionalize its supply chains.

    By May 12, 2025
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    Permission granted by Insulet
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    New Insulet CEO Ashley McEvoy sets priorities

    The diabetes tech company raised its expectations for revenue and gross margins, despite the impact of tariffs.

    By May 9, 2025
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    Courtesy of Illumina
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    SEC ends probe of Illumina’s Grail acquisition

    The DNA sequencing company also cut its 2025 earnings outlook to reflect the impact of tariffs on its business.

    By May 9, 2025
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    hapabapa via Getty Images
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    FDA, aiming to speed scientific reviews, names chief AI officer

    Commissioner Martin Makary also said the agency would roll out a generative AI system across its centers that will help FDA scientists spend less time on repetitive tasks.

    By May 9, 2025
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    Permission granted by The American Diabetes Association
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    Q&A

    ADA’s Osagie Ebekozien on diabetes tech for Type 2, new CGM standards

    Ebekozien, chief quality officer of the American Diabetes Association, said the nonprofit is seeing a shift with more devices authorized for Type 2 diabetes.

    By May 9, 2025
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    Alexander Ford via Getty Images
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    Bausch + Lomb receives CE mark for Luxlife intraocular lens

    The company plans to launch the lens, which supports vision at all distances, in Europe in the coming weeks.

    By May 9, 2025
  • President Donald Trump speaks at the White House on May 8, 2025.
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    Anna Moneymaker via Getty Images
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    US, UK reach deal on tariffs, market access

    The deal includes a reduced tariff for some U.K. automobiles and is the first the Trump administration has secured after unveiling its reciprocal tariff plan in April.

    By Philip Neuffer • May 8, 2025
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    Mario Tama / Staff via Getty Images
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    Masimo says cyberattack has impacted its ability to fulfill orders

    The maker of patient monitoring devices is working to bring the affected portions of its network back online and restore normal business operations.

    By David Jones • May 8, 2025
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    Courtesy of Siemens Healthineers
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    Earnings & Tariffs

    Siemens Healthineers lowers earnings forecast on expected tariff hit

    The company expects a tariff impact of up to 300 million euros, with the biggest hit from European goods going to the U.S.

    By May 8, 2025
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    Mario Tama / Staff via Getty Images
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    Masimo finds buyer for consumer audio business

    In addition to offloading the Sound United segment for $350 million, the company lowered its 2025 profit forecast to account for tariffs.

    By May 7, 2025
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    Jack Taylor via Getty Images
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    AdvaMed calls for ‘zero for zero’ medtech tariffs between US and UK

    AdvaMed and its British counterpart called for urgent action to ensure the situation “does not devolve into a crisis.”

    By May 7, 2025
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    Andrew Harnik via Getty Images
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    HHS overhaul

    RFK’s FDA layoffs could slow safety communications, experts warn

    The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety alerts.

    By May 6, 2025
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    Hraun via Getty Images
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    US semiconductor import probe looms over medtech industry

    Medical device manufacturers could face increased costs if the Commerce Department's Section 232 probe leads to tariffs on chips.

    By May 6, 2025
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    Patrik Stollarz / Staff via Getty Images
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    Earnings & Tariffs

    Philips cuts earnings forecast after calculating $340M tariff hit

    CEO Roy Jakobs said tariff impacts require the company to accelerate localization of production in the U.S.

    By May 6, 2025
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    Sasirin Pamai via Getty Images
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    Earnings & Tariffs

    Zimmer Biomet expects $60M to $80M tariff impact this year

    The orthopedics company lowered its earnings forecast, accounting for the tariffs and closing the acquisition of Paragon 28.

    By May 6, 2025
  • A closeup of Edwards Lifesciences' Sapien 3 heart valve.
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    Courtesy of Edwards Lifesciences
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    Edwards gains expanded TAVR label for asymptomatic patients

    The medical technology company expects the new indication to increase sales in its transcatheter aortic valve replacement business with more patients becoming eligible for the treatment.

    By May 5, 2025
  • U.S. President Donald Trump watches as Health and Human Services Secretary Robert F. Kennedy Jr. (C) swears in Dr. Mehmet Oz (R) as the Medicare and Medicaid Services Administrator during a ceremony in the Oval Office at the White House on April 18, 2025 in Washington, DC.
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    Andrew Harnik / Staff via Getty Images
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    Tracker

    Trump policies are upending healthcare. Track the effect on the medtech industry here.

    Policies and actions reshaping the healthcare industry began pouring out of President Donald Trump’s White House nearly from day one. Follow the changes affecting the medical device industry.

    By MedTech Dive Staff • May 5, 2025
  • An operating room has a table surrounded by screens and several overhead lights, and a surgical robot that says "Mako"
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    Permission granted by Stryker
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    Earnings & Tariffs

    Stryker expects $200M tariff hit, lowers earnings forecast

    CEO Kevin Lobo said that without the tariffs, the company would have “raised our earnings without question.”

    By May 2, 2025