Medical Devices

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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
  • 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
  • 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
  • A headshot of new Olympus CEO Bob White.
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    Courtesy of Olympus
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    Olympus, Revival Healthcare partner to start GI robotics firm

    Olympus and Revival Healthcare Capital agreed to invest up to $458 million combined to co-found a company that will develop a robotic platform for gastrointestinal treatment.

    By • July 28, 2025
  • U.S. President Donald Trump and European Commission President Ursula von der Leyen shake hands after concluding trade negotiations on July 27, 2025, in Turnberry, Scotland
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    Andrew Harnik via Getty Images
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    Trump tariffs

    US, EU agree to lower tariffs in ‘framework’ deal

    Most imports from the bloc would face a 15% tariff under the pact, U.S. President Donald Trump and European Commission President Ursula von der Leyen announced Sunday.

    By Philip Neuffer • July 28, 2025
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    Permission granted by Native Design
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    Sponsored by Native

    Value creation through innovation and design

    To lead in this era, medtech companies must expand how they innovate — combining scientific rigor with human connection, intuitive design, efficient operations and strategic clarity.

    July 28, 2025
  • European Union President Ursula von der Leyen stands at EU headquarters on May 20, 2025, in Brussels, Belgium
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    Omar Havana via Getty Images
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    Trump tariffs

    EU preps latest round of US tariff countermeasures

    The European Commission plans to install duties of up to 30%, starting Aug. 7, if the bloc cannot reach a deal with the U.S. by the end of the month.

    By Philip Neuffer • July 25, 2025
  • Edwards Lifesciences' Sapien 3 Ultra heart valve replacement system is shown with the valve expanded by a balloon.
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    Courtesy of Edwards Lifesciences
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    Edwards loses longtime TAVR leader Larry Wood

    Wood, who helped build Edwards’ TAVR business, will become CEO of Procept BioRobotics. Edwards also raised its sales and earnings outlook for the full year.

    By • July 25, 2025
  • A modern architectural design building featuring a red-brick façade with large glass windows displays a prominent sign of the Food and Drug Administration.
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    Alamy
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    Edwards recalls arterial cannulas over exposed wires

    Exposed wires could puncture the artery and cause bleeding, inadequate perfusion and hemolysis, the FDA said in its Class I recall notice.

    By • July 25, 2025
  • A person points to a scan on a screen.
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    Courtesy of Aidoc
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    Aidoc raises $150M for AI foundation model

    The technology, called CARE, is expected to allow for faster development of AI models that can cover more health conditions.

    By • July 24, 2025
  • A person holds a phone, wearing a white patch on their forearm and an insulin pump on their hip.
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    Courtesy of Medtronic
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    Medtronic receives Type 2 label expansion for MiniMed 780G in Europe

    The CE mark also allows Medtronic’s automated insulin delivery system to be used during pregnancy and by children as young as 2.

    By • July 23, 2025
  • Intuitive Surgical's da Vinci 5 robotic system.
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    Courtesy of Intuitive Surgical
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    Earnings & Tariffs

    Intuitive Surgical tempers tariff impact expectations

    Executives also addressed Medicaid concerns and competition from third-party suppliers of remanufactured surgical instruments on an earnings call.

    By • July 23, 2025