Cardiac


  • Shot of three business persons filling in paperwork in an office.
    Image attribution tooltip
    Violeta Stoimenova via Getty Images
    Image attribution tooltip

    Haemonetics to offload whole-blood business for up to $67M

    Selling the assets to Italy’s GVS should help Haemonetics improve its revenue growth and profit margins, analysts said.

    By Dec. 4, 2024
  • A large group of dosing pens for subcutaneous injection of anti-obesity medication piled in a heap.
    Image attribution tooltip
    aprott via Getty Images
    Image attribution tooltip

    Biden administration proposes Medicare, Medicaid coverage of pricey weight loss drugs

    About 7.4 million Americans with obesity could have insurance coverage for drugs like Wegovy if the Trump administration allows the rule to go into effect — at the cost of $40 billion to federal and state governments.

    By Rebecca Pifer • Nov. 27, 2024
  • Front sign of FDA building Explore the Trendline
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    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
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic’s ablation sales slowed by PFA supply issues

    CEO Geoff Martha said the business did not meet internal growth expectations last quarter due to third-party supply issues that have now been resolved.

    By Nov. 19, 2024
  • A closeup of Boston Scientific's Watchman FLX device is shown against a white background.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    Boston Scientific’s Watchman could be new option for patients post ablation: study

    The trial compared the stroke prevention device for left atrial appendage closure to blood thinners in people who underwent cardiac ablation for AFib.

    By Nov. 18, 2024
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    Image attribution tooltip

    The PFA race is heating up. Here’s where the market stands after J&J’s approval.

    Boston Scientific, Medtronic and J&J are moving quickly to secure their place in the fast-growing pulsed field ablation space as new devices and heart imaging technology hit the market.

    By Nov. 18, 2024
  • A row of empty desks with one office chair sticking out into the walkway.
    Image attribution tooltip

    Photo illustration: Shaun Lucas/Industry Dive; Getty Images

    Image attribution tooltip

    Haemonetics to close California facility, lay off 75 people

    Over the past year, Haemonetics has reshaped its product portfolio through restructuring and M&A, adding devices used in cardiology procedures.

    By Nov. 14, 2024
  • Boston Scientific's Farapulse pulsed field ablation device.
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip

    Boston Scientific resumes PFA trial in new patient group after pausing enrollment

    Boston Scientific expects to complete enrollment in the coming months in the study comparing pulsed field ablation to anti-arrhythmic drugs in patients with persistent AFib, a spokesperson said.

    By Nov. 12, 2024
  • A picture of a blue pulsed field ablation catheter against a gray background.
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    Image attribution tooltip

    J&J wins FDA approval for Varipulse PFA system

    J&J is the third medtech company to gain U.S. approval for pulsed field ablation, a new atrial fibrillation treatment seeing rapid adoption.

    By Nov. 7, 2024
  • A coil-shaped device is shown moving through a tube with branching structures around it.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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 view of the Edwards Lifesciences headquarters building with three people walking in front.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    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
  • 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.
    Image attribution tooltip
    Courtesy of Abiomed
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    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
  • An image of Edwards Lifesciences' Irvine, California, campus at dusk.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    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
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    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.
    Image attribution tooltip
    Retrieved from iRhythm on October 22, 2024
    Image attribution tooltip

    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
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    Image attribution tooltip

    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
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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
    Image attribution tooltip
    Mario Tama via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Abbott
    Image attribution tooltip

    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