Medical Devices: Page 3

  • 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
  • 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
  • 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
  • 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 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
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    Permission granted by ZimVie
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    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.
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    Courtesy of Globus Medical
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    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.
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    Tierney L. Cross via Getty Images
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    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
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    Courtesy of HeartFlow
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    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.
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    Courtesy of Whoop
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    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.
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    Alamy
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    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
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    Sarah Silbiger via Getty Images
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    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
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    Abbott

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    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.
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    Courtesy of Intuitive Surgical
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    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
  • A headshot of Per Langoe, new CEO of GT Medical, wearing a suit jacket.
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    Permission granted by GT Medical Technologies
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    GT Medical closes $53M round to commercialize brain tumor device

    The money will also help the company complete enrollment in a randomized controlled trial of patients with newly diagnosed brain metastases.

    By • July 16, 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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    Earnings & Tariffs

    ‘We are not rolling over’: J&J electrophysiology unit rebounds amid PFA rivalry

    The division returned to growth in the second quarter after declining over the previous three months. Now, can the healthcare giant catch up with its rivals in pulsed field ablation?

    By • July 16, 2025
  • A photo of Monogram Orthopedics' surgical robot.
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    Permission granted by Monogram Orthopedics
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    Zimmer bets on autonomous surgery with Monogram purchase

    The orthopedics firm is looking to round out its robotics offerings with the planned $177 million acquisition. Some analysts questioned the value of a fully autonomous robot.

    By • July 16, 2025
  • A physician sits at the console of Medtronic's Hugo robotic surgery system.
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    Permission granted by Medtronic
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    Medtronic gets CE mark for robot-driven vessel-sealing device

    Medtronic said its market-leading LigaSure technology can now be used with its Hugo soft tissue robotic surgery system in Europe.

    By • July 15, 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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    Zimmer to buy robotics firm Monogram for about $177M

    Monogram Technologies’ surgical robot for total knee replacements is expected to give Zimmer Biomet’s customers more options and drive robotic knee adoption in the U.S.

    By • July 14, 2025