Cardiac: Page 3

  • 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
  • Front sign of FDA building Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
  • 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
  • Medtronic's Affera all-in-one ablation system
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    Courtesy of Medtronic
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    Medtronic wins FDA approval for Affera mapping and ablation system

    Affera combines mapping technology with a catheter capable of performing radiofrequency and pulsed field ablation.

    By • Oct. 25, 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 boosts PFA expectations, citing rapid Farapulse adoption

    Demand for the pulsed field ablation device drove the company’s electrophysiology sales up 177% in the third quarter compared to a year ago.

    By • Oct. 23, 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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    iRhythm’s Zio AT design changes win FDA clearance

    The agency cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.

    By • Oct. 23, 2024
  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Boston Scientific, Edwards and Dexcom usher in second week of earnings

    Johnson & Johnson, Abbott and Intuitive Surgical made a mixed start to earnings season last week.

    By • Oct. 22, 2024
  • A view of Boston Scientific's Farawave system to treat atrial fibrillation.
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    Courtesy of Boston Scientific
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    Boston Scientific wins FDA approval for Farapulse cardiac mapping

    Stifel analyst Rick Wise said Boston Scientific can now offer “one-stop-shopping” with a pulsed field ablation catheter and integrated mapping system to treat atrial fibrillation.

    By • Oct. 21, 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 blood-blocking agent tied to additional 2 deaths, 8 injuries

    After a February recall, Boston Scientific has warned physicians about new safety risks for Obsidio Embolic, which is now connected to a total of 15 injuries and four deaths.

    By • Oct. 21, 2024
  • Johnson & Johnson's new logo is seen on an office lobby wall.
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    Courtesy of Johnson & Johnson
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    J&J’s recent medtech buys help to prop up devices unit

    Johnson & Johnson’s medtech acquisitions over the past year have fueled growth for its cardiovascular group, offsetting challenges in businesses like orthopedics and surgery.

    By • Oct. 15, 2024
  • Medtronic's Affera all-in-one ablation system
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    Courtesy of Medtronic
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    Medtronic to evaluate Affera in ventricular tachycardia

    The FDA approved an early feasibility study of Medtronic’s Affera mapping and ablation system and Sphere-9 catheter in patients with ventricular tachycardia, an abnormal heart rhythm.

    By • Oct. 15, 2024
  • J&J, Auris, Fortis
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    Mario Tama via Getty Images
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    J&J, Abbott and Intuitive kick off latest medtech earnings season

    From pulsed field ablation to diabetes tech and surgical robots, the updates will provide an early look at how key medtech markets performed last quarter.

    By • Oct. 14, 2024
  • A picture of a medical catheter against a white background.
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    Courtesy of Abbott
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    Abbott enrolls pivotal PFA study 4 months ahead of schedule

    The company reported the enrollment milestone alongside news that it received clearance to sell its Advisor HD Grid X Mapping Catheter and started a trial of its Tactiflex Duo Ablation Catheter.

    By • Oct. 11, 2024
  • A closeup of a doctor examining a patient using a stethoscope.
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    FG Trade via Getty Images
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    Elucid wins FDA 510(k) nod for heart plaque image analysis software

    The software turns coronary CT angiography images into 3D models that quantify and classify plaque morphology to improve predictions of heart attack and stroke risk.

    By • Oct. 4, 2024
  • Red human heart drawing on blue background
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    Jolygon via Getty Images
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    FDA authorizes Pi-Cardia’s valve-in-valve TAVR device

    Pi-Cardia designed the Shortcut device to mitigate the risk of coronary artery obstruction by splitting aortic valve leaflets before valve placement.

    By • Oct. 3, 2024
  • A nighttime shot of Chicago's downtown and river.
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    halbergman via Getty Images
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    Top medtech conferences in 2025

    The lineup includes industrywide conferences and events covering the latest medtech trends in diabetes, orthopedics, cardiac care and surgical robotics.

    By • Updated Jan. 23, 2025
  • An anatomical heart is pictured in red in a transparent body.
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    magicmine via Getty Images
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    Recalled heart devices had limited clinical testing, study finds

    Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.

    By • Sept. 24, 2024
  • Exterior view of a building with columns and a sign that says "Cook."
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    Courtesy of Cook Medical
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    Merit Medical inks $210M takeover of Cook’s lead management business

    Merit predicts the portfolio, which includes devices used in procedures to remove or replace heart rhythm device leads, will add $40 million a year to its sales.

    By • Sept. 18, 2024
  • An image of Spectrawave's Hypervue intravascular imaging system.
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    Courtesy of Spectrawave
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    J&J leads $50M financing for imaging company Spectrawave

    The Series B round will support commercial expansion and product additions for Spectrawave’s system used in the treatment of coronary artery disease.

    By • Sept. 11, 2024
  • A person in a blue shirt applies a blood pressure cuff to a person wearing a cardigan.
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    SDI Productions via Getty Images
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    European heart group recommends renal denervation for some patients

    The European Society of Cardiology said the treatment may be considered for certain patients with uncontrolled, drug-resistant high blood pressure but outlined lingering concerns.

    By • Sept. 4, 2024
  • V-Wave's implantable device for heart failure is shown next to a dime.
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    Permission granted by Johnson & Johnson
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    J&J to buy heart failure implant maker V-Wave for up to $1.7B

    J&J has agreed to pay $600 million upfront for the private company as it works to expand its portfolio of cardiovascular devices.

    By • Aug. 20, 2024
  • An image of Edwards Lifesciences' Irvine, California, campus at dusk.
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    Courtesy of Edwards Lifesciences
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    Edwards spends $1.2B on 2 heart device firms, extending deal streak

    Alongside the acquisitions, Edwards reported a slowdown in its core TAVR business in the second quarter that sent its shares tumbling.

    By • July 25, 2024
  • Photo of Michael F. Mahoney, CEO of Boston Scientific.
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    Courtesy of Boston Scientific
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    Boston Scientific tips strong growth for Farapulse after successful launch

    Questions on Boston Scientific’s pulsed field ablation system once again dominated the company’s earnings call.

    By • July 24, 2024
  • Medtronic's Stacey Churchwell is pictured wearing a blue suit jacket and white shirt.
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    Permission granted by Medtronic
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    Q&A

    ‘Our next frontier is prediction’: Medtronic on AI and heart disease

    Stacey Churchwell, who leads the company’s cardiovascular diagnostics and services business, says artificial intelligence is reducing false positives in its insertable cardiac monitors, saving clinicians valuable time.

    By • July 22, 2024
  • An image of the Abbott Volt pulsed field ablation catheter.
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    Permission granted by Abbott
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    Abbott previews PFA, over-the-counter CGM markets

    Electrophysiology sales held up against rivals’ launches of pulsed field ablation systems. Meanwhile, Abbott is gauging sales of its first OTC CGMs. 

    By • July 18, 2024