Medical Devices: Page 36

  • A building in front of a pond with the sign "Medtronic" on a stone wall.
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    Courtesy of Medtronic
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    Medtronic estimates up to 40 job losses in Ireland due to restructuring

    The company confirmed the potential job reductions from shutting down its ventilator product lines in an email to MedTech Dive.

    By • March 5, 2024
  • The Dexcom G7 Continuous Glucose Monitoring (CGM) System
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    Courtesy of Dexcom
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    Dexcom, Novo Nordisk call for FDA input on digital diabetes detection devices

    The companies want clarity on what evidence would be needed for new technologies to detect undiagnosed Type 2 diabetes or prediabetes.

    By • March 4, 2024
  • the FDA Headquarters Explore the Trendline➔
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • A windowed building surrounded by trees with a sign "Baxter" in front
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    Tim Boyle via Getty Images
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    Baxter considers selling kidney care unit to private equity

    The company expects to divest its largest segment, whether through a spinoff or a sale, in the second half of the year.

    By • March 4, 2024
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images
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    GE Healthcare recalls incubators due to risk of newborns falling

    The Food and Drug Administration labeled the recall as a Class I event after a serious injury was reported.

    By • March 4, 2024
  • Illustration of a catheter with a cylindrical sheath
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    Permission granted by Boston Scientific
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    Boston Scientific gains FDA nod for drug-coated coronary balloon

    BTIG analyst Marie Thibault said physicians could rapidly adopt the first-of-its-kind device.

    By • March 1, 2024
  • An image of Abbott's electrophysiology chief medical officer Christopher Piorkowski, who is smiling and wearing a suit and tie.
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    Permission granted by Abbott
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    Q&A

    Abbott leader on the ‘hype’ and ‘reality’ of pulsed field ablation

    Christopher Piorkowski, chief medical officer for the electrophysiology business, talks about the high expectations for the new atrial fibrillation treatment.

    By • March 1, 2024
  • 4 clear and 4 opaque discs on a white background.
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    juankphoto via Getty Images
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    FDA responds to claim breast implant removal is ‘reasonable’ to cut cancer risk

    Experts convened by the American Association of Plastic Surgeons concluded it may be “considered reasonable” to remove textured breast implants to reduce the risk of a rare cancer.

    By • Updated March 4, 2024
  • A building in front of a pond with the sign "Medtronic" on a stone wall.
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    Courtesy of Medtronic
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    Medtronic asks ITC to stop sales, imports of Axonics devices

    The complaint is the latest move in a long-running patent fight between the two companies regarding neuromodulation devices.

    By • March 1, 2024
  • A person sits in front of a plate of food, holding a smartphone. They're wearing a patch on their left arm.
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    Courtesy of Insulet Corp.
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    Insulet sizes up competition as Tandem, Medtronic plan new insulin patch-pumps

    Insulet CEO Jim Hollingshead said the company is “very confident” in its competitive position as rivals develop their own patch pumps.

    By • Feb. 29, 2024
  • Professional photo of Jan De Witte
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    Courtesy of Integra Lifesciences
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    Integra Lifesciences CEO Jan De Witte to retire

    The company is working to restart a factory in Boston after problems at the plant led to a sweeping recall in 2023. De Witte will stay with Integra until it finds a successor. 

    By • Feb. 29, 2024
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
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    Courtesy of Johnson & Johnson
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    J&J’s pulsed field ablation system secures European approval

    The device maker will vie against rivals Boston Scientific and Medtronic in the market for the new treatment for atrial fibrillation.

    By • Feb. 29, 2024
  • A head shot of Charlotte Hanneman.
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    Courtesy of Royal Philips
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    Philips names Stryker’s Charlotte Hanneman as CFO

    Abhijit  Bhattacharya, who took over as CFO in 2015 and has spent 37 years with the company, will step down in October.

    By • Feb. 29, 2024
  • Signs for Johnson & Johnson are seen on company offices in California.
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    Mario Tama via Getty Images
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    J&J begins enrolling patients in Laminar LAA pivotal trial

    The new device is meant to compete with systems offered by Boston Scientific and Abbott that address blood clot risk in atrial fibrillation.

    By • Feb. 28, 2024
  • Professional photo of Dave Hickey
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    Permission granted by Becton Dickinson
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    BD life sciences president Dave Hickey to retire July 1

    The company has yet to name Hickey’s replacement but plans to have a successor in place before the executive retires.

    By • Feb. 28, 2024
  • A gloved hand holds a spiral shaped device with six clips
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    Retrieved from Hologic on February 28, 2024
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    Hologic’s radiographic markers targeted in FDA safety communication

    The agency has seen reports the implants can move out of position and break through the skin.

    By • Feb. 28, 2024
  • A brick building with a sign that says "Henry Schein Inc."
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    Bruce Bennett via Getty Images
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    Henry Schein expects cyber incident costs to continue in 2024

    The company reported a $350 million to $400 million reduction in Q4 sales due to the incident, which forced it to take some systems offline. 

    By • Feb. 27, 2024
  • A surgeon holds a piece of surgical mesh for hernia and abdominal wall surgery.
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    Courtesy of Integra
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    Integra Lifesciences to cut about 60 jobs as it closes Indiana site

    Manufacturing will be transferred to a plant in Maryland as part of a strategy to bolster operational efficiency, a company spokesperson said.

    By • Feb. 27, 2024
  • Virtual Incision's Mira robotic-assisted surgical system next to an operating table.
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    Permission granted by Virtual Incision
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    Virtual Incision wins FDA de novo nod for miniaturized surgical robot

    The device weighs about two pounds and fits into a tray that can be carried between operating rooms.

    By • Feb. 27, 2024
  • A building in front of a pond with the sign "Medtronic" on a stone wall.
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    Courtesy of Medtronic
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    Medtronic will transfer or offer comprehensive support to workers affected by ventilator exit

    The company did not state how many people may be affected by the decision, announced last week, to shut down its ventilator product lines.

    By • Feb. 26, 2024
  • The concept of the word M&A on cubes on a beautiful green background. Business concept
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    Zhanna Hapanovich via Getty Images
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    Agiliti to go private in $2.5B PE deal

    After the transaction’s expected close in the first half of this year, Agiliti will no longer trade on the New York Stock Exchange.

    By • Feb. 26, 2024
  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    FDA warns against using smart wearables that claim to measure blood sugar

    Unauthorized smartwatches and smart rings are “manufactured by dozens of companies and sold under multiple brand names,” according to the agency.

    By • Feb. 23, 2024
  • A headshot of Per Langoe, new CEO of GT Medical, wearing a suit jacket.
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    Permission granted by GT Medical Technologies
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    Q&A

    New GT Medical CEO Per Langoe on driving adoption of brain tumor therapy

    Langoe, the former head of Palette Life Sciences, spoke about his plans to expand use of GT Medical’s cancer-fighting implant.

    By • Feb. 23, 2024
  • Zimmer Biomet's Rosa robotic surgery system.
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    Permission granted by Zimmer Biomet
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    Zimmer receives FDA clearance for robotic shoulder system

    The clearance poises the orthopedics company to be first to market with robotic-assisted shoulder replacement surgery.

    By • Feb. 22, 2024
  • A headshot of Agilent CEO-elect Padraig McDonnell wearing a blue suit jacket.
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    Courtesy of Agilent
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    Agilent’s McDonnell to succeed retiring CEO McMullen

    Mike McMullen, a 40-year veteran of Agilent and predecessor Hewlett-Packard, plans to retire on Oct. 31.

    By • Feb. 22, 2024
  • tort liability, earplugs, Aearo Technologies
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    "3M headquarters" by Acroterion is licensed under CC BY-SA 4.0
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    3M to spin off health unit April 1

    The company broke down Solventum’s expected growth and risks as a standalone business in a recent federal filing.

    By • Feb. 22, 2024