The Latest

  • Jeff Shuren stands in front of a podium.
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    Permission granted by Peyton Helbert / AAMI
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    CDRH Director Shuren to step down after 15 years

    Michelle Tarver, deputy director for transformation, will serve as acting director of the FDA’s medical devices unit.

  • 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.

  • J&J HQ
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    Mario Tama via Getty Images
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    Top 5 medtech deals in the first half of 2024

    The first six months of the year brought a series of multibillion-dollar deals, led by Johnson & Johnson’s $13.1 billion takeover of Shockwave Medical.

  • 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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    Cook Medical to sell reproductive health business to private equity firm

    Astorg intends to combine the Cook assets with Hamilton Thorne, another reproductive health business it plans to buy. 

  • An image of ICU Medical's Plum Duo infusion pump system.
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    Retrieved from ICU Medical on July 23, 2024
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    ICU Medical to close Minnesota facility, cut 83 jobs

    The infusion pump maker has focused on consolidating service centers and manufacturing sites since it bought Smiths Medical in 2022.

  • A lab technician runs Guardant Health's Shield blood test for colorectal cancer screening in a lab.
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    Courtesy of Business Wire
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    Guardant settles allegations it violated the False Claims Act

    The settlement resolves claims that an oncologist ordered significantly more tests after Guardant hired two people the physician recommended for jobs at the company.

  • 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.

  • Embecta CEO Dev Kurdikar stands at a podium that says "Nasdaq" while people clap around him.
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    Permission granted by Nasdaq
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    Diabetes device firm Embecta considers sale: Financial Times

    Two years after Embecta spun out of BD, the firm is now exploring a potential sale, the Financial Times reported. 

    M&A
  • A photograph of the exterior of the Food and Drug Administration headquarters in Maryland.
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    Sarah Silbiger via Getty Images
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    FDA sends 2 warning letters after inspecting Chinese syringe manufacturers

    One warning letter covers the production of plastic syringes for Cardinal Health.

  • A large rectangular device says Truvian with a cartridge next to it.
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    Courtesy of Truvian
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    Truvian raises $74M to bring blood test instrument to market

    The device is designed to perform the most commonly ordered blood tests, avoiding the need to send the samples to central labs.

  • A picture of the surgeon's console for Intuitive Surgical's da Vinci 5 surgical robot.
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    Courtesy of Intuitive Surgical
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    Intuitive’s da Vinci 5 robot launch ‘well ahead’ of Wall Street expectations

    Early customer feedback on the new robot suggests features such as improved ergonomics and vision technology are helping drive adoption, executives said.

  • A person stands in front of the screen of a machine on wheels, near a sign that says "GE HealthCare"
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    Stringer via Getty Images
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    GE Healthcare to buy AI software from Intelligent Ultrasound for $51M

    After purchasing Caption Health last year, GE Healthcare plans to add another artificial intelligence acquisition to the company.

  • Patient's view of dentist holding two dental instruments.
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    Peter Macdiarmid via Getty Images
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    Dental implant maker Osstem in talks to acquire Zimvie: report

    Bloomberg first reported M&A rumors in June when Zimvie was approached about a takeover.

  • CrowdStrike booth at RSA Conference in San Francisco.
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    Matt Kapko/MedTech Dive
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    CrowdStrike outage hits US hospitals

    The cybersecurity firm released what was meant to be a routine software update, but now health systems, including CommonSpirit Health and Cleveland Clinic, are locked out of Windows systems.

  • A picture of an Abbott testing building.
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    Ryan David Brown/Getty Images via Getty Images
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    Deep Dive

    Medtech firms have cut more than 14,000 jobs in the past 18 months

    Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.

    Updated July 25, 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. 

  • Close up of a droplet being dropped into a test tube
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    deliormanli via Getty Images
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    Danaher setting up labs to support companion diagnostic development

    Danaher plans to open a U.K. laboratory this month, followed by a second facility in the U.S. later this year.

  • Qiagen's NeuMoDx 96 PCR sequencing machine
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    Courtesy of Qiagen
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    Qiagen to cut 175 employees, close Michigan PCR test plant

    The layoffs and plant closure are part of a restructuring plan that Qiagen estimates will cost about $400 million.

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    Mario Tama via Getty Images
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    J&J medtech fails to meet growth expectations

    CFO Joe Wolk told investors Wednesday that Johnson & Johnson’s medical device business missed the company’s 5%-7% growth forecast in the second quarter.

  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest closing Pennsylvania lab, laying off 121 people

    Quest is consolidating drug testing at a facility in Kansas, but will keep rapid response, pathology and IT staff at the Norristown site.

  • Intuitive Surgical's da Vinci 5 robotic system.
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    Courtesy of Intuitive Surgical
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    J&J, Abbott and Intuitive start medtech earnings season

    The companies’ financial results will offer a glimpse at the current health of medtech markets.

  • A person dressed in business attire sits in a white chair against a black background. IWhite glowing letters behind the chair read, "colli..."
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    The image by Ramsey Cardy/Collision/Sportsfile is licensed under CC BY 2.0
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    Masimo sues activist investor Politan, postpones annual meeting

    The latest turn in the recent drama comes days after proxy advisory firms ISS and Glass Lewis backed two Politan nominees for Masimo’s board.

  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    FDA creates communication ‘super office’ at CDRH

    The changes are part of a broader reorganization intended to increase organizational agility and help the agency meet user fee commitments.

  • A corporate building for Edwards Lifesciences.
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    Courtesy of Edwards Lifesciences
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    Edwards to acquire Innovalve, stake in Affluent Medical

    The heart valve specialist said in a federal filing that it expects to pay $300 million in cash for Innovalve Bio Medical when the deal closes.

  • The exterior of the U.S. Capitol building in Washington, D.C.
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    Jemal Countess via Getty Images
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    House committee tells FDA to suspend lab developed test rule

    Lawmakers said the final rule carries “the risk of greatly altering the United States’ laboratory testing infrastructure.”