Medical Devices: Page 19


  • A person holds a yellow and blue pen, showing the expiration date.
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    Joe Raedle via Getty Images
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    Patient shares a day in the life with diabetes at FDA’s first Home Health Hub meeting

    The initiative, led by new CDRH Acting Director Michelle Tarver, is intended to improve health equity by including people’s living conditions in device design.

    By July 30, 2024
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    ridvan_celik via Getty Images
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    Asensus updates Karl Storz merger filing after investors make demands

    Asensus denied that there were deficiencies in the original disclosure of the proposed takeover by Karl Storz but voluntarily expanded on details to avoid lawsuits or delays.

    By July 30, 2024
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
  • A person walks in a forest with a square device taped to their thigh.
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    Courtesy of Tandem Diabetes Care
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    Q&A

    Tandem CMO shares Mobi feedback, expansion plans

    MedTech Dive caught up with Chief Medical Officer Jordan Pinsker to talk about early feedback on Tandem’s smallest insulin pump and what’s next for the device.

    By July 29, 2024
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    Patrik Stollarz / Staff via Getty Images
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    Philips’ orders and sales held back by China’s anti-corruption push

    Hospitals in China increased internal approval cycles to comply with anti-corruption measures.

    By July 29, 2024
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    Permission granted by Dexcom
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    Dexcom shares plunge on lower sales outlook

    “I’m just kind of in shock,” an analyst said on the earnings call, asking for more detail on the forecast cut.

    By July 26, 2024
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    Permission granted by Abbott Laboratories
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    Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose readings

    A spokesperson for Abbott said the recall “may impact less than 1% of Libre 3 users in the U.S.”

    By July 26, 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
  • A rounded, white device sits on a table with a clear mask on top.
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    rustycanuck via Getty Images
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    Owens & Minor inks $1.36B takeover of Rotech

    Rotech will help Owens & Minor get closer to its 2028 sales goal with home medical equipment, including sleep and oxygen devices, hospital beds and wheelchairs.

    By July 25, 2024
  • A picture of Inspire Medical Systems' patient app and remote.
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    Courtesy of Inspire Medical Systems
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    Inspire Medical chief operating officer leaving to take CEO role

    Philip Ebeling said he is resigning to become president and CEO of “a private medical device company operating in the cardiology space.”

    By July 25, 2024
  • 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.

    By , July 24, 2024
  • 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.

    By July 24, 2024
  • 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.

    By July 23, 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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    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. 

    By July 23, 2024
  • 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.

    By July 22, 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
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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.

    By July 19, 2024
  • 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.

    By July 19, 2024
  • 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.

    By July 19, 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
  • 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.

    By , , Updated July 25, 2024
  • 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.

    By July 17, 2024
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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.

    By July 17, 2024
  • 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.

    By July 16, 2024
  • 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.

    By July 16, 2024
  • 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.

    By July 16, 2024