Medical Devices: Page 4


  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
    Image attribution tooltip
    hapabapa via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Permission granted by Dexcom
    Image attribution tooltip

    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
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip
    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
  • GE HealthCare's Omni Legend PET/CT system.
    Image attribution tooltip
    Courtesy of GE HealthCare
    Image attribution tooltip
    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.
    Image attribution tooltip
    Courtesy of Siemens Healthineers
    Image attribution tooltip
    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
    Image attribution tooltip
    Patrik Stollarz / Staff via Getty Images
    Image attribution tooltip
    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.
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Olympus
    Image attribution tooltip

    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
    Image attribution tooltip
    Andrew Harnik via Getty Images
    Image attribution tooltip
    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
  • Header Image
    Image attribution tooltip
    Permission granted by Native Design
    Image attribution tooltip
    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
    Image attribution tooltip
    Omar Havana via Getty Images
    Image attribution tooltip
    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.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    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.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Aidoc
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Intuitive Surgical
    Image attribution tooltip
    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
  • A view of Baxter International's production facility in the state of North-Rhine Wetsphalia on January 15, 2021 in Halle, Germany.
    Image attribution tooltip
    Sascha Schuermann via Getty Images
    Image attribution tooltip

    Baxter recalls certain Novum pumps over issues tied to 79 injuries, 2 deaths

    The company has advised users to change the pump and infusion set at a time when a delay in treatment would not harm the patient.

    By July 23, 2025
  • ZimVie's CEO, Vafa Jamali
    Image attribution tooltip
    Permission granted by ZimVie
    Image attribution tooltip

    ZimVie to sell to investment firm for about $730M

    The announcement follows reports that the dental equipment company was considering a sale after receiving takeover offers.

    By July 22, 2025
  • A headshot of Globus Medical CFO, COO Keith Pfeil.
    Image attribution tooltip
    Courtesy of Globus Medical
    Image attribution tooltip

    Globus promotes Keith Pfeil to CEO as former exec leaves for Dentsply

    Truist Securities analysts said that “a surprise CEO change can always drive incremental uncertainty, and the announcement comes within months of reporting disappointing [first-quarter] results.”

    By July 22, 2025
  • The flag outside the United States Environmental Protection Agency building is seen on August 21, 2024 in Washington, DC.
    Image attribution tooltip
    Tierney L. Cross via Getty Images
    Image attribution tooltip

    Trump delays ethylene oxide emissions standards for device sterilizers

    The proclamation would push back implementation of the EPA’s rule on the carcinogenic gas for two years as the Trump administration reconsiders several emissions standards.

    By Updated July 21, 2025
  • Heartflow
    Image attribution tooltip
    Courtesy of HeartFlow
    Image attribution tooltip

    Heartflow files for IPO

    The company reported revenue of $37.2 million in the first quarter, up 39% year over year, but said it has faced challenges in achieving higher rates of adoption in the past.

    By July 21, 2025
  • A person hits a soccer ball with their head while wearing a wristband.
    Image attribution tooltip
    Courtesy of Whoop
    Image attribution tooltip

    Whoop’s FDA warning letter sparks debate over blood pressure as a wellness metric

    Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and should not be regulated as a medical device.

    By July 18, 2025
  • The building features a modern glass façade with the Nasdaq logo prominently displayed. Surrounding the structure are other commercial buildings and digital billboards, which are characteristic of the vibrant Times Square environment.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Carlsmed seeks up to $103M IPO haul to fuel spine surgery growth

    The company’s custom implants compete with devices from Medtronic, Johnson & Johnson and Globus Medical.

    By July 18, 2025
  • FDA
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    Integra recalls cranial drills over defect linked to 10 injuries

    The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA said.

    By July 17, 2025
  • Abbott BinaxNOW home COVID-19 test
    Image attribution tooltip

    Abbott

    Image attribution tooltip
    Earnings & Tariffs

    Abbott lowers sales forecast on diagnostics decline, US funding cuts

    Medical device sales remained a bright spot for the company, however, with more than 20% growth in diabetes devices.

    By July 17, 2025
  • A surgeon sits at the console of a da Vinci 5 robot while another medical professional works in the background.
    Image attribution tooltip
    Courtesy of Intuitive Surgical
    Image attribution tooltip
    News roundup

    Intuitive demos telesurgery; SS Innovations marks 100 robot installs

    The demonstration of a trans-Atlantic operation using Intuitive Surgical’s da Vinci 5 robot on a tissue model was a focus at the Society of Robotic Surgery meeting in France.

    By July 16, 2025