Medical Devices: Page 25


  • 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
  • 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 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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    libre de droit via 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
  • Businessman calculating expenses
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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
  • 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
  • Professional photo of Kevin Sayer
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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
  • A person on a stationary bike wears a small, white patch on their upper arm.
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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