Medical Devices: Page 30


  • A windowed building surrounded by trees with a sign "Baxter" in front
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    Getty Images
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    Baxter agrees to sell kidney care unit to Carlyle for $3.8B

    Selling the business, called Vantive, rather than spinning it off, should maximize shareholder value and give Baxter more flexibility to pursue other growth opportunities, the company said.

    By Aug. 13, 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 wins FDA approval for asleep deep brain stimulation

    Medtronic said Monday it is the first company to receive FDA approval to offer DBS surgery while a patient is asleep or awake.

    By Aug. 13, 2024
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline
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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 picture of Breas Medical's  Vivo 45 LS ventilator device against a white background.
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    Retrieved from Breas Medical on August 12, 2024
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    Breas Medical flags risk of formaldehyde exposure in ventilators

    Testing showed the potential for short-term exposure to elevated levels of formaldehyde under specific conditions.

    By Aug. 12, 2024
  • Professional photo of Bryan Hanson
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    Courtesy of 3M
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    Solventum raises earnings forecast after first independent quarter

    Four months after separating from 3M, CEO Bryan Hanson told investors on Solventum’s first earnings call that “a lot could have gone wrong, and it didn’t.”

    By Aug. 9, 2024
  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    Smiths Medical recalls infusion pumps over software issues

    The devices may fail to emit alarms, have unresponsive stop and power keys, and reveal passwords.

    By Aug. 9, 2024
  • A headshot of new Axogen CEO Michael Dale.
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    Permission granted by Axogen
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    Axogen names ex-Abbott exec Michael Dale as CEO

    Dale will replace Karen Zaderej, who is leaving the provider of peripheral nerve injury devices after 14 years as CEO.

    By Aug. 9, 2024
  • An x-ray image shows a hip bone with an overlay showing an angle.
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    Courtesy of Orthogrid Systems
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    Zimmer to buy surgical navigation company Orthogrid

    CEO Ivan Tornos said Zimmer hopes to grow its market share in hip procedures with the purchase. He also shared an update on the company’s new shoulder surgical robot.

    By Aug. 8, 2024
  • Chiquita Brooks-LaSure sits behind a desk testifying before a congressional subcommittee.
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    Rebecca Pifer/MedTech Dive
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    CMS finalizes notice on Medicare coverage for breakthrough devices

    Through the new pathway, called Transitional Coverage for Emerging Technologies, the CMS will consider five medical device candidates yearly for national coverage.

    By Aug. 8, 2024
  • A metal, rounded device says "Senza Omnia" and has two attached leads.
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    Courtesy of Nevro
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    Nevro considers sale as competition for pain market ramps up

    CEO Kevin Thornal told investors Nevro felt “an urgency” to respond to a market that is being reshaped by direct and indirect competition.

    By Aug. 8, 2024
  • A person stands outside wearing a small, square device with a cord on their belt.
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    Permission granted by Medtronic
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    Abbott, Medtronic partner on diabetes tech

    Abbott will develop a glucose sensor that can only connect with Medtronic's insulin delivery technology.

    By Aug. 7, 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’s slow recovery from cyber incident hits Q2 results

    William Blair analysts said the “lingering impacts from the cyberattack are somewhat surprising.”

    By Aug. 7, 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 recalls nerve monitoring system linked to 10 injuries

    Medtronic has asked users to be aware the devices may not alert when on a nerve, which could lead to injuries during surgery.

    By Aug. 7, 2024
  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    FDA seeks feedback on health equity for medical devices

    The agency plans to develop a framework for when devices should be evaluated in diverse populations to support marketing authorization.

    By Aug. 6, 2024
  • A person playing a guitar in front of a microphone holds up a phone with a blood glucose reading on it.
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    Courtesy of Ascensia Diabetes Care
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    Q&A

    Ascensia’s new head of CGM talks plans for a 365-day sensor

    Brian Hansen recently joined Ascensia, which markets Senseonics’ implantable glucose sensors. The current version lasts 180 days, but Senseonics is seeking FDA approval for a one-year sensor.

    By Aug. 6, 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 wins FDA approval for obstructive sleep apnea neurostimulator therapy

    Inspire plans to start a soft launch of the device late in 2024 and move into a full release in 2025.

    By Aug. 5, 2024
  • A picture of J&J's Velys robotic surgery sytem.
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    Courtesy of Johnson & Johnson
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    J&J launches Velys Spine surgical robotics and navigation platform

    With its Velys surgical robotics portfolio, J&J aims to take market share from competitors Stryker and Zimmer Biomet.

    By Aug. 5, 2024
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    Courtesy of 23andMe
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    23andMe board rejects CEO Wojcicki’s take-private proposal

    A special committee of the board said the proposal offers no premium to 23andMe’s stock price, and with a lack of committed financing, is “insufficient.”

    By Aug. 2, 2024
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    Courtesy of Philips
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    Philips sues independent lab, alleges ‘numerous egregious errors’ in CPAP foam tests

    Philips claimed PSN Labs overestimated the potential threat to patients, saying it “would have pursued a different and more focused recall” if not for the results.

    By Aug. 2, 2024
  • Illustration of a blood clot blocking red blood cells within an artery or a vein.
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    Getty Images
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    Inari promotes Kevin Strange to CFO

    Mitch Hill, who has been in the role since 2019, will retire effective Oct. 1.

    By Aug. 2, 2024
  • A headshot of Daniel Wilson, iRhythm's incoming CFO.
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    Permission granted by iRhythm Technologies
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    iRhythm names Daniel Wilson CFO after Brice Bobzien steps down

    Along with outlining the succession plan, CEO Quentin Blackford updated investors on an earnings call about the company’s response to an FDA warning letter.

    By Aug. 2, 2024
  • A GE Healthcare C-arm imaging device
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    Courtesy of GE Healthcare
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    GE Healthcare faces pressure in China as hospitals delay orders

    Johnson & Johnson’s medtech business and Philips also cited China’s order slowdown for sluggish revenue growth in the second quarter.

    By Aug. 1, 2024
  • A picture of Megadyne's Mega Soft pediatric patient return electrode pad.
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    Courtesy of Johnson & Johnson
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    FDA, Health Canada team up to raise awareness of J&J’s Megadyne recall

    Agency officials are working together to communicate the risk of burns tied to Megadyne electrode pads.

    By Aug. 1, 2024
  • A person holds a tablet showing an image of their hip bones while a person wearing a white coat sits across the table.
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    Courtesy of Stryker
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    Stryker plans ‘very active’ M&A, ortho robot launches in 2H

    After another record quarter of orthopedic robot installations, CEO Kevin Lobo hinted at a potential interest in soft tissue robots.

    By July 31, 2024
  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    FDA sends warning letter to defibrillator battery manufacturer

    Amco makes batteries for automated external defibrillators sold by companies including Philips, Stryker and Zoll.

    By July 31, 2024
  • 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