Medical Devices: Page 39


  • layoffs
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    Stock via Getty Images
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    Globus lays off Nuvasive employees after merger

    More than 150 positions in California were cut in January, according to a state notice reviewed by MedTech Dive.

    By Jan. 26, 2024
  • A green leaf on top of a white Apple logo outside a glass building at night.
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    Sascha Steinbach via Getty Images
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    How Masimo forced Apple to redesign its smartwatches

    In a long-running patent dispute, Masimo has compelled the tech giant to remove the pulse oximetry function of certain Apple Watches.

    By Jan. 26, 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
  • 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 sells ear, nose and throat devices to C2Dx

    The transaction completes Cook’s divestiture of its otolaryngology, head and neck surgery product lines.

    By Jan. 26, 2024
  • A rounded, metal device says "Liberta RC," next to a phone screen showing a battery life and a round, black device with a power button.
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    Permission granted by Abbott
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    Abbott gets approval for new rechargeable deep brain stimulation system

    The decision comes just weeks after Medtronic received approval for its latest rechargeable device.

    By Jan. 25, 2024
  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain

    The reorganization establishes new divisions at the Office of Strategic Partnerships and Technology Innovation to account for its growth since 2019.

    By Jan. 25, 2024
  • Intuitive Surgical da Vinci robot, surgeon at surgeon console
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    Courtesy of Intuitive Surgical
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    Robot reveal: Intuitive submits 510(k) for next-generation system

    The new surgical robot will have 10,000 times the processing power of the current da Vinci model, CEO Gary Guthart said on the company’s fourth-quarter earnings call.

    By Jan. 24, 2024
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott says all four segments stronger than pre-pandemic

    CEO Robert Ford said investing in its base business using COVID-19 testing revenues was “absolutely the right strategy.”

    By Jan. 24, 2024
  • European Union flags are pictured waving outside the European Commission building.
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    Carl Court via Getty Images
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    European Commission proposes delays for IVDR to prevent supply disruption

    Officials are planning to give manufacturers another 31 months to get tests certified under the In Vitro Diagnostic Medical Devices Regulation.

    By Jan. 24, 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 on track to complete healthcare spinoff in first half of 2024

    The healthcare leadership team will share more details as the completion of the transaction approaches.

    By Jan. 24, 2024
  • A corporate building for Edwards Lifesciences.
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    Courtesy of Edwards Lifesciences
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    Edwards risks TAVR market share slip amid challenges from Abbott, Boston Scientific: survey

    Cardiologists predicted Edwards’ market share may erode slightly in the next two years, according to a survey commissioned by Leerink Partners.

    By Jan. 23, 2024
  • eight xray images side by side show rounded joints and pins in the hips and knees
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    real444 via Getty Images
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    Deep Dive

    Orthopedics leaders watch procedure backlog, new technologies in 2024

    J&J, Medtronic and Smith & Nephew executives and orthopedic surgeons said they expect more procedures to move outpatient, while questions about pricing and procedure backlogs loom over the medical technology industry. 

    By Jan. 23, 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’s closed-loop neuromodulation device cuts overstimulation in trial

    Most participants reported a significant reduction in overstimulation compared to open-loop spinal cord stimulation.

    By Jan. 22, 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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    3 bellwether companies to watch as medtech earnings season begins

    J&J, Intuitive Surgical and Abbott kick off this week with fourth-quarter reports.

    By Jan. 22, 2024
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott starts study of PFA device in humans, targets 2024 US trial

    RBC analysts predict Volt could launch in the U.S. as early as 2026.

    By Jan. 19, 2024
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA authorizes record number of new devices in 2023

    The FDA shared the figures in the CDRH’s annual report, which also features updates on its work on MDUFA V goals.

    By Jan. 18, 2024
  • Three watches stand on display with digital screens.
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    Justin Sullivan via Getty Images
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    Apple to sell watches without pulse oximetry after ban of original design takes effect

    A court Wednesday denied Apple’s request for an extended stay on an import ban of its smartwatches, after the International Trade Commission found the products infringed Masimo’s patents.

    By Jan. 18, 2024
  • Dermasensor's real-time, non-invasive skin cancer evaluation system.
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    Courtesy of Dermasensor
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    Dermasensor wins FDA clearance for AI-enabled skin cancer detection device

    A study found the sensitivity of the device was 96%, compared with 83% for primary care physicians.

    By Updated Jan. 22, 2024
  • Professional photo of 3M
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    Courtesy of 3M
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    Nuvasive’s former CEO joins 3M spinoff

    Chris Barry will become group president of the Medical Solutions Division for 3M’s healthcare business.

    By Jan. 17, 2024
  • nerve signals in brain
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    Stock via Getty Images
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    Imvaria and Darmiyan receive FDA authorizations for AI-enabled diagnostic tools

    The de novo classifications cover software for detecting a lung condition and assessing dementia risk.

    By Jan. 17, 2024
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA warns of shoulder implant risks after Exactech declines to start voluntary recall

    Agency officials advised healthcare professionals against implanting Equinoxe Shoulder Systems packaged in defective bags.

    By Jan. 17, 2024
  • Two wooden blocks on a computer keyboard that spell out "M&A"
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    Maks_Lab via Getty Images
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    Integer acquires Pulse Technologies for $140M

    Pulse specializes in the micro machining of components for medical devices used in markets such as structural heart.

    By Jan. 16, 2024
  • Glasses, coding and reflection with business man reading software development analytics, database and system error report for information technology.
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    Kobus Louw via Getty Images
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    EssilorLuxottica integrates tech into glasses to target hearing loss market

    The glasses feature microphones, speakers and algorithms to amplify speech, but the technology is hidden in the frame.

    By Jan. 16, 2024
  • Appl
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    Eric Thayer via Getty Images
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    Apple, locked in patent fight with Masimo, redesigns smartwatch

    The tech giant could bring to market watches without a pulse oximetry feature to avoid an ITC ban on sales of versions now on the market.

    By Jan. 16, 2024
  • UK Parliament
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    Retrieved from Wikimedia Commons on December 15, 2021
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    UK shares roadmap for creation of new medtech regulatory framework

    The MHRA plans to have the “core elements” of the new framework for medical devices in place by the next year.

    By Jan. 12, 2024
  • A person lies in bed wearing a CPAP mask over their nose and mouth.
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    Courtesy of Resmed
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    Resmed’s magnetized masks linked to 6 patient injuries, FDA says

    The company contacted customers in November after determining magnets should be kept away from active implants and metallic medical devices.

    By Jan. 12, 2024