Medical Devices: Page 2


  • An illustration of human lungs with a geometrical effect.
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    eranicle via Getty Images
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    Apreo raises $130M for pivotal trial of emphysema device

    The company, which received investment from the venture capital wing of Intuitive Surgical, has designed the device to work in a broader patient population than existing treatments.

    By Aug. 11, 2025
  • A person smiles while wearing a square device on their hip and a round device on their upper arm.
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    Courtesy of Tandem Diabetes Care
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    Tandem, Insulet monitoring CMS payment proposal for diabetes tech

    The proposal would introduce competitive bidding for insulin pumps and change how Medicare pays for diabetes devices, if finalized.

    By Aug. 8, 2025
  • the FDA Headquarters Explore the Trendline
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • New Masimo CEO Katie Szyman wears a navy blue jacket and white shirt.
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    Permission granted by Masimo
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    Masimo appoints several senior execs, resolves cyber incident

    The pulse oximeter maker is now fully operational after a spring cyberattack and increased its 2025 profit forecast, but investors have raised questions about the status of a partnership with Philips.

    By Aug. 8, 2025
  • A closeup of Boston Scientific's Watchman FLX device is shown against a white background.
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    Courtesy of Boston Scientific
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    Boston Scientific updates instructions of devices linked to 17 deaths

    The update covers devices used in procedures to implant the company’s Watchman heart device.

    By Aug. 8, 2025
  • A commercial building displays a “Boston Scientific” sign on its exterior. The structure features a smooth white facade with reflective windows and minimal architectural detailing, set against a partly cloudy sky.
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    Alamy
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    Boston Scientific tells users about defibrillator problem linked to deaths, injuries

    A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the leads cannot be assumed or confirmed.

    By Aug. 7, 2025
  • A square screen shows a graph of blood glucose levels and a bolus option.
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    Courtesy of Tandem Diabetes Care
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    Tandem insulin pump malfunction linked to 59 injuries

     A problem with speakers in Tandem’s t:slim X2 insulin pumps can cause insulin delivery to stop, the company said.

    By Aug. 7, 2025
  • President Donald Trump speaks during a presentation in the Oval Office of the White House on Aug. 6, 2025, in Washington D.C.
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    Win McNamee via Getty Images
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    Trump plans 100% tariffs for semiconductor imports

    Chips are one of several product types currently under Section 232 investigation by the White House, a frequent precursor to duties.

    By Philip Neuffer • Aug. 7, 2025
  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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    BD commits $35M to expand US syringe production plant

    The company said it has grown capacity by 10% this year, bringing its total U.S. output of the prefilled flush syringes to above 750 million units.

    By Aug. 6, 2025
  • The Federal Trade Commission emblem on the Constitution Center in Washington, D.C.
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    Laurel Deppen/MedTech Dive
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    FTC moves to block Edwards’ JenaValve acquisition

    Edwards Lifesciences and JenaValve said they remained committed to completing the deal and would defend the case in court.

    By Aug. 6, 2025
  • A person speaks at a podium.
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    Elise Reuter/MedTech Dive
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    Medical device industry says future MDUFA hikes unsustainable

    Device lobbyists’ priorities contrasted with patient advocates, who sought an increase in user fees and more funds for postmarket safety.

    By Aug. 5, 2025
  • European Union President Ursula von der Leyen speaks with U.S. President Donald Trump on July 27, 2025, in Turnberry, Scotland.
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    Andrew Harnik via Getty Images
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    EU delays countermeasures to US tariffs by 6 months

    The bloc has now paused implementation three times, with the latest moratorium coming after reaching a framework deal with the U.S.

    By Philip Neuffer • Aug. 5, 2025
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips BiPAP machine recall associated with 8 deaths

    Philips sent updated instructions after disclosing problems last year with an alarm that can interrupt treatment for people with obstructive sleep apnea or respiratory insufficiency.

    By Aug. 5, 2025
  • An older women's eye is seen up close.
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    Alexander Ford via Getty Images
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    Alcon to acquire STAAR Surgical for about $1.5B

    BTIG analyst Ryan Zimmerman called the transaction “a solid deal” for Alcon given STAAR’s struggles in the China market.

    By Aug. 5, 2025
  • A robotic aortic valve replacement procedure is depicted.
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    Courtesy of CardioPrecision
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    First Corcym aortic valve implanted via new robotic procedure

    CEO Christian Mazzi said the minimally invasive surgical technique could provide better outcomes for patients than transcatheter aortic valve replacement.

    By Aug. 5, 2025
  • Heartflow
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    Courtesy of HeartFlow
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    Heartflow prices IPO, aiming to net about $180M

    The company, which sells software for creating 3D heart models, plans to offer 12.5 million shares at a range of $15 to $17 per share.

    By Aug. 4, 2025
  • Vicarious Surgical's robotic system.
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    Courtesy of Vicarious Surgical
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    Vicarious Surgical names Stephen From as next CEO

    From, who joins the surgical robot developer from Aruna Bio, will take the reins from co-founder Adam Sachs on Aug. 7.

    By Aug. 1, 2025
  • President of Mexico Claudia Sheinbaum delivers a speech as part of the presidential inauguration on Oct. 1, 2024, in Mexico City.
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    Cristopher Rogel Blanquet via Getty Images
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    Trump tariffs

    US, Mexico agree to extend USMCA-tariff pause

    The two countries will continue to negotiate over a 90-day period during which imports from Mexico will avoid a planned 30% tariff from the Trump administration. 

    By Philip Neuffer • Aug. 1, 2025
  • Monogram Technologies' robotic surgery system is displayed against a gray background.
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    Permission granted by Monogram Technologies
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    News roundup

    Monogram robot marks autonomy milestone; Stereotaxis catheter cleared

    Monogram Technologies conducted its first fully autonomous robotic knee replacement surgery, while Stereotaxis won FDA clearance for a robotically navigated electrophysiology mapping catheter.

    By July 31, 2025
  • Modern office building with tall glass windows and palm trees lining the entry drive. A large white and green sign in the foreground reads “Dexcom” with the number “6350” below. Surrounding the sign are colorful landscaping features including small bushes, flowers, and a mulched bed. Cars and flags are visible in the background.
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    Alamy
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    Dexcom raises sales expectations, discusses G8 plans

    Outgoing CEO Kevin Sayer expects expanding coverage of Dexcom’s glucose sensors for people with Type 2 diabetes and over-the-counter devices to drive future growth.

    By July 31, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    hapabapa via Getty Images
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    Cardiosense wins FDA clearance for wearable heart monitor

    The device captures various types of heart data that could be used in AI models for cardiovascular parameters with the aim of lowering barriers to monitoring.

    By July 31, 2025
  • Professional photo of Kevin Sayer
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    Permission granted by Dexcom
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    Dexcom CEO Kevin Sayer to step down

    Jake Leach will take over the role at the start of 2026, with Sayer remaining chairman of the board after the transition.

    By Updated July 31, 2025
  • GE HealthCare's Omni Legend PET/CT system.
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    Courtesy of GE HealthCare
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    Earnings & Tariffs

    GE HealthCare projects reduced tariff expense

    Executives also said demand for capital equipment continues to be healthy. However, investors may have expected stronger order growth.

    By July 30, 2025
  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
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    Courtesy of Siemens Healthineers
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    Earnings & Tariffs

    Siemens Healthineers cuts tariff impact after trade talk breakthrough

    The company predicted a full-year impact of 200 million to 250 million euros, down from its previous forecast of up to 300 million euros.

    By July 30, 2025
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Earnings & Tariffs

    Philips lowers expected tariff hit to 150M to 200M euros

    The company previously forecast an up to 300 million euro tariff impact in 2025 before the U.S. struck agreements with China and the European Union.

    By July 29, 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’s Ethicon recalls stapler cartridges over issue linked to 1 death

    The FDA said the device can lock, leading to adverse events including surgical delay, bleeding and death.

    By Updated July 29, 2025