Medical Devices: Page 41


  • 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
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendlineâž”
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    Permission granted by Boston Scientific
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
  • 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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    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
  • Cartoon hand that is holding a smartphone with a health application.
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    Getty Images
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    Better Therapeutics wins breakthrough status for health app to treat liver disease

    The FDA awarded the designation after seeing evidence the digital cognitive behavioral therapy may help reduce liver fat.

    By Feb. 21, 2024
  • Jeff Shuren stands in front of a podium.
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    Permission granted by Peyton Helbert / AAMI
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    CDRH’s Shuren backs expansion of TAP program to speed device approval

    The FDA started the Total Product Lifecycle Advisory Program to help medtech companies cross the “valley of death” by getting agency feedback early.

    By Feb. 21, 2024
  • Close-up of a sign with office building and trees in background
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    Getty Images
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    FDA warns industry of ‘fraudulent’ third-party data in device applications

    The agency has seen a rise in data that are fabricated, duplicated or otherwise unreliable in premarket submissions.

    By Feb. 21, 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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    Medical device recall system ‘failing to meet the needs of public health,’ physicians find

    Amid a GAO review of recalls, the physicians advised the watchdog to revisit unique device identifiers and clarify the FDA’s enforcement authority.

    By Feb. 20, 2024
  • UK medical device reviewers form new association

    The group intends to help the medical device sector navigate a post-Brexit regulatory landscape.

    By Feb. 20, 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 exits ventilator business, creates new patient monitoring and respiratory unit

    The decision reverses a strategy announced more than a year ago to separate the slower-growth patient monitoring and respiratory interventions businesses.

    By Feb. 20, 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 names Raman Venkatesh as first chief sustainability officer

    Venkatesh will be responsible for leading the development and execution of Medtronic’s environmental sustainability strategy.

    By Feb. 16, 2024
  • Portrait of Bill Hunter
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    Permission granted by Canary Medical
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    Q&A

    Canary CEO Bill Hunter talks smart knee implant progress, new heart device

    The company collaborated with Zimmer Biomet on its Persona IQ device, which is slated for a full market release this year. Canary is also working on an implantable monitor for heart failure patients.

    By Feb. 15, 2024
  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    Smiths Medical recalls syringe pumps for software malfunction

    The FDA categorized the recall as Class I, noting that the software faults may cause pumps to fail, delaying or interrupting therapy.

    By Feb. 15, 2024
  • Masmio's Mightysat medical fingertip pulse oximeter.
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    Courtesy of Masimo
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    Masimo wins first FDA clearance for OTC medical fingertip pulse oximeter

    The company's OTC device, which costs nearly $300, will compete with consumer pulse oximeters that are widely available but lack FDA clearance.

    By Feb. 14, 2024
  • Abbott Laboratories
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    Courtesy of Abbott
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    FDA advisory panel overwhelmingly backs Abbott’s Triclip

    The expert panel voted unanimously in favor of the safety of the tricuspid valve device, despite questions about a potential placebo effect in the trial.

    By Feb. 14, 2024
  • Close up of a watch on a person's wrist that says "sleep apnea 10:17 am"
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    Courtesy of Samsung Electronics
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    Samsung wins de novo nod for watch that detects sleep apnea

    The FDA created special controls that provide a path to market for other developers of over-the-counter devices.

    By Feb. 14, 2024
  • Header image for "Chapter 11 Bankruptcy Filings Climbed 79% in March"
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    Getty Images
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    Invitae files for Chapter 11 bankruptcy

    The genetic testing company hopes to keep its employees on payroll as it works through a court-overseen sale.

    By Feb. 14, 2024
  • A cylindrical device on the left with a wifi signal, next to a black rounded device and a smartphone showing a blood glucose reading.
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    Permission granted by Senseonics
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    Senseonics gains expanded Medicare coverage for implantable CGM

    Three Medicare Administrative Contractors will start covering the Eversense E3 CGM for people who only take basal insulin.

    By Feb. 13, 2024
  • Xray of a man's knee
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    Getty Images
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    Robotic knee replacement revision rate no better than traditional surgery: study

    Orthopedics companies such as Stryker and Zimmer Biomet have promoted robotic knee surgery as a more accurate technique.

    By Feb. 13, 2024
  • Silhouette of stressed businesswoman in the office.
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    Getty Images
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    Medtech companies lay off thousands in 2024, continuing last year’s trend

    With the year drawing to a close, Masimo, Smith & Nephew and Boston Scientific are among the medtech companies to announce job cuts.

    By MedTech Dive Staff • Updated Dec. 17, 2024