Medical Devices: Page 24

  • 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.

    The FDA has rolled out an AI tool agency-wide, while a proposed HHS budget shows large cuts for the National Institutes of Health.

    By MedTech Dive Staff • Updated June 6, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Permission granted by Boston Scientific
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    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
  • 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
  • Surgeon and Nurses at Surgery Room
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    Getty Images
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    News roundup

    Intuitive wins new FDA nod for single port robot; Resmed buys diagnostic facility

    Intuitive secured a single port robot clearance, Resmed bought sleep testing facility Virtuox, and Precision Neuroscience hired an executive to support its BCI commercialization plans.

    By • May 2, 2025
  • Epic's logo on top of its booth at HIMSS23.
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    Rebecca Pifer/MedTech Dive
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    Abbott integrates diabetes data into Epic’s electronic health records

    Linking the systems will allow clinicians to view glucose data captured by Libre glucose sensors within Epic’s systems.

    By • May 1, 2025
  • A computer tomography machine has two screens on the sides showing patient results.
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    Courtesy of GE Healthcare
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    Earnings & Tariffs

    GE Healthcare slashes 2025 profit forecast on tariff impact

    The full-year tariff impact of 85 cents per share would have more than doubled without mitigation actions underway, executives said on the earnings call.

    By • April 30, 2025
  • A conceptual illustration of neural activity in a brain.
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    Getty Images
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    Senators call for investigation into BCI privacy

    In a letter to the FTC, three Democratic senators called for privacy standards for brain computer interface technology.

    By • Updated April 30, 2025
  • A building in front of a pond with the sign "Medtronic" on a stone wall.
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    Courtesy of Medtronic
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    Medtronic wins FDA approval for defibrillation lead

    Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, according to Medtronic.

    By • Updated May 5, 2025
  • A picture of a medical catheter against a white background.
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    Courtesy of Abbott
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    News roundup

    4 PFA studies in the spotlight at Heart Rhythm 2025

    Boston Scientific, Medtronic, Abbott and J&J unveiled new data for their PFA devices in tandem with the Heart Rhythm Society’s annual meeting.

    By • April 29, 2025
  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    ICU Medical receives FDA warning letter over infusion pumps

    Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

    By • April 29, 2025
  • A photo of Thermo Fisher's manufacturing facility in Plainville, Massachusetts.
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    Courtesy of Thermo Fisher Scientific
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    Earnings & Tariffs

    Thermo Fisher commits $2B to US manufacturing

    The company said the investment will create high-paying jobs and add lab services capacity to its domestic healthcare supply chain.

    By Nathan Owens • April 28, 2025
  • Professional photo of Ashley McEvoy
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    Permission granted by Insulet
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    Ashley McEvoy named Insulet CEO

    McEvoy, the former leader of Johnson & Johnson’s medtech business, started immediately. Jim Hollingshead, who was CEO of Insulet for three years, resigned on Monday but will work as a consultant.

    By • April 28, 2025
  • Stacked containers at the Hamburg Port in Germany on Feb. 27, 2025.
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    Morris MacMatzen via Getty Images
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    Earnings & Tariffs

    Trump’s tariff effect has dominated medtech earnings calls

    While J&J, Abbott and Boston Scientific have all said the White House’s tariff policies will cost them hundreds of millions of dollars, yearly forecasts have remained in place — or even increased.

    By • April 28, 2025
  • Four medtronic Hugo surgical robots
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    Courtesy of Medtronic
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    Medtronic submits Hugo soft tissue robot for FDA approval

    William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.

    By • April 28, 2025
  • A doctor shines a light in a patient's eye.
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    Getty Images
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    Bausch + Lomb will resume intraocular lens sales weeks after recall

    An analysis of the timing of adverse event reports has convinced the company that raw material delivered by a vendor was the source of the problem.

    By • April 28, 2025
  • A puzzle with business leader stick figures sits on a wooden desk, with three pieces sitting on the side.
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    Getty Images
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    Michael Greiner leaves Avanos over offer under new CEO

    Avanos did not offer Greiner a position comparable to the one he held before becoming interim CEO last year.

    By • April 25, 2025
  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Boston Scientific CFO Dan Brennan to retire after nearly 30 years with the company

    Jon Monson, currently Boston Scientific's senior vice president for investor relations, will replace Brennan beginning June 30.

    By • April 25, 2025
  • A person stands outside wearing a small, square device with a cord on their belt.
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    Permission granted by Medtronic
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    Medtronic seeks FDA nod for insulin pump, furthering Abbott collab

    Receiving FDA clearance would allow Medtronic to pair its pumps with a glucose monitor being developed for the company by Abbott.

    By • April 24, 2025
  • Trump signs an executive order at the Oval Office.
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    Anna Moneymaker via Getty Images
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    Device developers advance AI plans despite Trump uncertainty

    Trump administration policies have raised questions about how the FDA will regulate AI in medical devices. AdvaMed board members think the agency should keep its leading role.

    By • April 24, 2025
  • A closeup of Edwards Lifesciences' Sapien 3 heart valve.
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    Courtesy of Edwards Lifesciences
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    Earnings & Tariffs

    Edwards shrugs off tariffs, backs 2025 profit forecast

    The heart valve specialist saw better-than-expected TAVR sales in the first quarter as hospitals addressed capacity constraints that have dogged its core business.

    By • Updated April 30, 2025
  • A headshot of Field Medical CEO Steven Mickelsen.
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    Permission granted by Field Medical
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    Field Medical raises $40M for PFA in ventricular tachycardia

    Led by Farapulse founder Steven Mickelsen, Field has developed a pulsed field ablation device to tackle the dangerous heart rhythm disorder.

    By • April 23, 2025
  • A surgeon using a davinci intuitive robot
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    Courtesy of Intuitive
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    Earnings & Tariffs

    Intuitive lowers profit margin forecast due to tariff pressure

    CFO Jamie Samath cautioned that the trade environment, financial pressures on hospitals and macroeconomic risks could extend timelines for robot purchases.

    By • April 23, 2025
  • A vessel full of containers traveling through a European waterway.
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    Dan Kitwood via Getty Images
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    Trump tariffs

    Who are the United States’ top trading partners?

    Explore how over 200 countries’ imports, exports and trade balances with the U.S. last year stack up in this sortable chart.

    By Edwin Lopez • April 23, 2025
  • Front sign of FDA building
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    Sarah Silbiger via Getty Images
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    FDA issues early alert for BD catheters due to leaks

    BD recalled certain intravascular catheters tied to reports of 10 serious injuries after finding an increase in cracks from “material fatigue.”

    By • April 21, 2025
  • Two gloved hands hold a flexible yellow strip with small dots on one end.
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    Courtesy of Precision Neuroscience
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    Precision Neuroscience receives FDA clearance for brain implant

    The electrode array, which can be implanted for 30 days to map brain activity, is a component of Precision Neuroscience’s planned brain-computer interface system.

    By • April 21, 2025