Medical Devices: Page

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    Chip Somodevilla via Getty Images
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    How the healthcare industry is reacting to a second Trump term

    Donald Trump’s first term as president was characterized by significant turbulence for government healthcare programs. Here’s how some of the most influential industry groups responded to the Republican’s reelection.

    By Rebecca Pifer Parduhn • Nov. 11, 2024
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    Getty Images
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    Inquis raises $40M for pivotal trial of clot removal device

    The Aventus thrombectomy system uses technology that tells operators if the device’s tip is in contact with blood, a clot or vessel walls.

    By • Nov. 7, 2024
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
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    Courtesy of Siemens Healthineers
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    Siemens Healthineers confident it can cope with Trump tariffs

    CEO Bernd Montag said the company is well positioned for a “U.S. versus China situation” that could arise when Donald Trump returns to the White House.

    By • Nov. 7, 2024
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    Permission granted by Politan Capital Management
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    Masimo, amid leadership transition, targets cost reductions

    Executives said the patient monitoring company’s consumer business will likely become a discontinued operation if it is not spun off.

    By • Nov. 6, 2024
  • Close up of a robotic arm above several lines of test tubes, with people looking in through a glass window.
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    Courtesy of Ambry Genetics
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    Tempus AI to buy genetic testing company for $600M

    CEO Eric Lefkofsky said the purchase of Ambry Genetics will expand Tempus’ testing portfolio and bring in a fast-growing business.

    By • Nov. 6, 2024
  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
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    Getty Images
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    Advamed asks CMS to cover extra imaging of dense breast tissue

    Many patients with dense breast tissue currently have to pay out of pocket or forgo potentially life-saving additional testing, Advamed said in a letter.

    By • Nov. 6, 2024
  • A coil-shaped device is shown moving through a tube with branching structures around it.
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    Courtesy of Medtronic
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    Medtronic, Recor win CMS transitional payment coverage for renal denervation devices

    Patient and physician education is the next challenge to change the treatment paradigm for drug-resistant hypertension, Citi Research analyst Joanne Wuensch said.

    By • Nov. 5, 2024
  • A headshot of Mojdeh Paul against with a window and white wall in the background.
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    Courtesy of Integra LifeSciences Holdings Corporation
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    Integra Lifesciences names Mojdeh Poul as CEO

    Poul will take over the company in January after spending 11 years with 3M and working at Medtronic and Boston Scientific.

    By • Nov. 5, 2024
  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Boston Scientific continues M&A run with Cortex buy

    Cortex adds to Boston Scientific’s electrophysiology portfolio amid treatment shifts in the space driven by new pulsed field ablation devices.

    By • Nov. 4, 2024
  • A doctor puts a pulse oximeter on a patient's finger
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    Getty Images
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    Medtronic settles pulse oximetry lawsuit alleging inaccuracies

    Roots Community Health has sued 12 other firms, including GE Healthcare, CVS and Walgreens, and called for manufacturers and the FDA to ensure the devices work for everyone.

    By • Nov. 4, 2024
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    Getty Images
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    Zimmer licenses NeuroOne brain ablation system

    NeuroOne will get $3 million upfront for an exclusive license to distribute its radiofrequency ablation system designed to treat neurological disorders such as epilepsy and Parkinson's disease.

    By • Nov. 4, 2024
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    Permission granted by Johnson & Johnson
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    J&J Medtech CIO Larry Jones resigns

    Jones, who has led connectivity solutions for J&J’s surgical robots, announced his departure on LinkedIn.

    By • Updated Nov. 1, 2024
  • iRhythm's Zio AT cardiac monitor is shown against a white background.
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    Retrieved from iRhythm on October 22, 2024
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    FDA clears iRhythm’s second 510(k) in response to warning letter

    However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation efforts are further along.

    By • Nov. 1, 2024
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    Getty Images
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    EU posts guidance on ethylene oxide in device sterilization

    The document clarifies that EtO falls within the scope of the Medical Device Regulation and the In Vitro Diagnostic Regulation.

    By • Nov. 1, 2024
  • A view of the Edwards Lifesciences headquarters building with three people walking in front.
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    Courtesy of Edwards Lifesciences
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    Edwards, Medtronic and Inari share trial data at TCT conference

    The three medtech firms unveiled new data this week during TCT 2024 in Washington, D.C. Here’s what the results mean for the companies and their device markets.

    By • Oct. 31, 2024
  • Boston Scientific's Acurate neo2 TAVR device is shown close up against a white background.
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    Courtesy of Boston Scientific
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    Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study

    Analysts said the findings complicate the outlook for a U.S. launch of Boston Scientific's aortic valve replacement device.

    By • Oct. 31, 2024
  • Professional photo of Ivan Tornos
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    Permission granted by Zimmer Biomet
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    Stryker, Zimmer outline different M&A strategies

    Stryker CEO Kevin Lobo told investors M&A will be the “number one use of our cash going forward,” while Zimmer Biomet CEO Ivan Tornos emphasized internal product development for growth.

    By • Oct. 30, 2024
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    Getty Images
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    Exactech files for Chapter 11, agrees to investor buyout

    The filing follows Exactech’s failure to settle product liability claims from about 2,600 patients in response to recalls of orthopedic devices.

    By • Oct. 30, 2024
  • A closeup of Edwards Lifesciences' Sapien 3 heart valve.
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    Courtesy of Edwards Lifesciences
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    Edwards data show benefit of early TAVR over ‘watchful waiting’

    Study author Philippe Genereux said the trial data “shatter 60 years of ingrained belief on the treatment for severe aortic stenosis.”

    By • Oct. 29, 2024
  • An illustration of a heart bump inserted into a heart against a blue background.
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    Courtesy of Abiomed
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    J&J to seek FDA approval after small-bore Impella heart pump hits trial goal

    The company has predicted the narrower Impella ECP will be easier to insert and implant, as well as enable the use of small bore access and closure techniques.

    By • Oct. 29, 2024
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific to close Silk Road Medical headquarters, lay off 138 people

    Following its acquisition of Silk Road in September, Boston Scientific said it plans to consolidate the company’s work in Minnesota.

    By • Oct. 28, 2024
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips cuts sales forecast after ‘significant deterioration’ in China

    CEO Roy Jakobs expects the slump to continue into 2025, driven by China’s anti-corruption measures.

    By • Oct. 28, 2024
  • A person holds a clear, spiral shaped device with metal dots.
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    Retrieved from Hologic on May 23, 2024
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    FDA advises clinicians to stop using Hologic radiographic markers

    Hologic has recalled the Biozorb devices after 188 reports of adverse events in patients who received the implants in breast tissue.

    By • Oct. 28, 2024
  • Professional photo of Teri Lawver
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    Permission granted by Dexcom
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    Dexcom chief commercial officer to retire

    Teri Lawver is leaving the diabetes tech company during a challenging time, with sales slowing after a workforce restructuring.

    By • Oct. 25, 2024
  • An image of Edwards Lifesciences' Irvine, California, campus at dusk.
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    Courtesy of Edwards Lifesciences
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    Edwards’ TAVR sales faced ongoing hospital constraints in Q3

    Hurt by a slowdown in procedures for its heart valve replacement devices, Edwards said it is working with hospitals to manage workflow challenges.

    By • Oct. 25, 2024