Medical Devices: Page 57

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    Sarah Silbiger via Getty Images
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    FDA warns providers about using surgical mesh for breast surgery after BD label update

    The regulator reminded providers that there are “no surgical mesh products cleared or approved by the FDA for use in breast surgery.”

    By • Nov. 13, 2023
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    Courtesy of Grail
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    Illumina explores options for Grail, hires advisers

    The company, facing pressure from regulators to divest Grail, also formed a special committee to speed decisions on the fate of the liquid biopsy test maker.

    By • Nov. 10, 2023
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline➔
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    Courtesy of Intuitive Surgical
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    Trendline

    Top 5 stories from MedTech Dive

    From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    Mario Tama/Getty via Getty Images
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    J&J orthopedics subsidiary undergoes layoffs at Colorado facility

    DePuy Spine will cease manufacturing at the site as the medtech giant restructures its strategy in the sector.

    By Joelle Anselmo • Nov. 10, 2023
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    Acutus laying off 65% of employees to focus solely on Medtronic heart device deal

    The company has decided to exit the mapping and ablation business and focus its remaining cash on the Medtronic partnership.

    By • Nov. 10, 2023
  • An operating room has a table surrounded by screens and several overhead lights, and a surgical robot that says "Mako"
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    Permission granted by Stryker
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    4 takeaways from Stryker’s investor day

    The company’s expected return to pre-pandemic operating margins, procedure backlogs and weight loss drugs were among the topics discussed at Wednesday’s event.

    By • Nov. 9, 2023
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    Permission granted by Becton Dickinson
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    BD’s 2024 forecast comes in ‘well below’ Wall Street’s expectations

    Wall Street analysts called out BD’s disappointing 2024 EPS forecast in notes to investors, following a Thursday morning earnings call.

    By • Nov. 9, 2023
  • The Dexcom G7 Continuous Glucose Monitoring (CGM) System
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    Courtesy of Dexcom
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    NICE backs use of hybrid closed loop systems for Type 1 diabetes, if companies offer discounts

    The group’s recommendation gives around 150,000 people with Type 1 diabetes living in England the chance to access the systems, according to an NHS England official.

    By • Nov. 9, 2023
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    Mario Tama via Getty Images
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    J&J’s Ottava robot arriving too late to threaten Intuitive: analysts

    With J&J years from approval and hospitals committed to the da Vinci system, analysts see little threat to Intuitive for the foreseeable future.

    By • Nov. 9, 2023
  • Masimo W1 offers accurate, continuous health data and actionable health insights – from the leader in hospital pulse oximetry – in a personal, lifestyle-friendly watch. Building on Masimo’s decades of
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    Courtesy of Masimo
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    Masimo lowers outlook, citing constrained hospital budgets

    The patient monitoring company is also facing a slowdown in demand for the consumer audio products it acquired in a deal last year.

    By • Nov. 8, 2023
  • A rendering of Recor's Paradise renal denervation catheter within an artery. The red circle indicates the heat generated from the ultrasound energy in the tissue delivering energy within the artery.
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    Courtesy of Recor
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    Recor wins FDA approval for renal denervation system

    The approval makes Recor the first company to bring the treatment to the U.S. after getting an FDA panel nod in August. 

    By • Nov. 8, 2023
  • Persons in physician garb standing around Siemens Cios Spin Endobronchial imaging machine
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    Retrieved from Siemsens Website on July 01, 2022
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    Siemens Healthineers’ Varian rebounds; execs mum on diagnostics sale rumors

    The company's diagnostics unit continued to struggle amid layoffs and reports of a potential sale.

    By • Nov. 8, 2023
  • A surgeon using a davinci intuitive robot
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    Courtesy of Intuitive
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    Intuitive will weather weight-loss drug pressures, could see sales boost in ‘24: William Blair

    Obesity drugs are constraining Intuitive's growth today, but the robotic surgery specialist could receive a sales boost in 2024 as patients reschedule bariatric procedures.

    By • Nov. 8, 2023
  • A sign with company logo in red on a white background at the entrance to Johnson & JOhnson medical device unit
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    Mario Tama/Getty via Getty Images
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    J&J targets 2024 for Ottava FDA filing

    The company expects to file a submission for an investigational device exemption in the second half of 2024 that will allow it to begin clinical trials for the robotic surgery system.

    By • Nov. 7, 2023
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    Permission granted by Zimmer Biomet
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    Zimmer Biomet’s Ivan Tornos sets priorities for first year as CEO

    Tornos, who took the helm in August, said the company will grow through internal innovation and M&A.

    By • Nov. 7, 2023
  • A doctor puts a pulse oximeter on a patient's finger
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    Getty Images
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    25 attorneys general urge FDA to act fast to mitigate risk of racial bias in pulse oximetry

    The AGs want the FDA to “require manufacturers and vendors of pulse oximeters to include clear, comprehensible and evidence-based warning labels.”

    By • Nov. 7, 2023
  • Siemens Healthineers CLINITEST rapid COVID-19 antigen test
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    Courtesy of Siemens Healthineers
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    Siemens Healthineers to lay off 300 workers, move some manufacturing to Ireland

    The moves are part of a larger restructuring plan as its diagnostics business faces economic challenges.

    By • Nov. 6, 2023
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    Courtesy of Johnson & Johnson
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    J&J links radiofrequency catheter to improved quality of life in atrial fibrillation study

    Scores on a quality-of-life scale improved and use of antiarrhythmic drugs fell after people underwent treatment with the device.

    By • Nov. 6, 2023
  • Gloved hand touching a medical device that shows heart rate in a medical facility.
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    sfam_photo/Shutterstock.com

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    Sponsored by Shyft Global Services

    The 6 Rs of sustainability and the Hippocratic Oath

    Learn how key pillars of the Hippocratic Oath can guide sustainability for medical device OEMs.

    Nov. 6, 2023
  • 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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    5 companies to watch as medtech earnings wind down

    Zimmer Biomet, BD, Masimo, Illumina and Medtronic are all set to report financial results as the medtech earnings season draws to a close.

    By • Nov. 6, 2023
  • An x-ray image of a person's pelvis shows a hip replacement on the left side.
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    Getty Images
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    Stryker in ‘sprint back to 2019’ as procedures grow and supply chain, staffing pressures improve

    The company expects a procedure backlog to boost orthopedic surgery demand in the fourth quarter and through 2024.

    By • Nov. 3, 2023
  • A device with a clear cylinder in the middle and tubing coming out of the top.
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    Permission granted by Penumbra
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    Penumbra touts benefits of vacuum thrombectomy for PE in late-breaking data

    An interim analysis of Penumbra’s Indigo aspiration system met its primary safety and efficacy criteria, according to data shared at the Vascular Interventional Advances Conference.

    By • Nov. 3, 2023
  • Google COVID-19 support
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    Retrieved from Google on May 28, 2020
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    Elective procedure interest still topping pre-COVID levels, survey finds

    Google searches for 20 elective surgeries in the U.S. were at 112% of pre-COVID levels in the week ended Oct. 28, according to a report from Needham analysts.

    By • Nov. 3, 2023
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    Inari Medical to buy limb-saving device maker LimFlow for up to $415M

    The deal includes $250 million in cash upfront and additional payments based on reaching commercial and reimbursement milestones.

    By • Nov. 3, 2023
  • A windowed building surrounded by trees with a sign "Baxter" in front
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    Getty Images
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    Baxter completes biopharma solutions sale, business unit revamp

    The company plans to use most of the $3.7 billion in after-tax proceeds from the biopharma solutions sale to repay debt.

    By • Nov. 2, 2023
  • 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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    CooperCompanies buys reproductive health products from Cook Medical after failed takeover

    The company paid $300 million to buy certain maternal fetal medicine and gynecological surgery products. 

    By • Nov. 2, 2023