Medical Devices: Page 43

  • Rendering of a spiral-shaped catheter with four electrodes
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    Permission granted by Medtronic
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    Medtronic receives FDA approval for renal denervation device

    The company received approval for the hypertension treatment despite a mixed vote from an FDA advisory panel.

    By • Nov. 20, 2023
  • 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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    B. Braun infusion pump safety correction linked to 51 complaints, one death

    While no devices need to be removed, the FDA labeled the correction a Class I recall due to the risk of injury or death for patients.

    By • Nov. 20, 2023
  • 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 street sign marks the intersection of Wall and Broad Streets in Manhattan.
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    rabbit75_ist/iStock/Getty Images Plus via Getty Images
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    Q3 recap: Medtech firms grapple with layoffs, GLP-1s and China slowdown

    Despite these challenges, companies also flagged improvements in supply chain dynamics and pricing that could boost their earnings.

    By • Updated Nov. 21, 2023
  • Close-up of a sign with office building and trees in background
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    Sarah Silbiger via Getty Images
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    FDA acts on industry call for clarity about scope of device shortage reporting rules

    The agency posted a final guidance and draft guidance on medical device shortage reporting requirements, addressing industry concerns.

    By • Nov. 17, 2023
  • A man using an at-home pulse oximeter.
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    No name give, Prostock-Studio via Getty Images
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    FDA seeks feedback on racial bias of pulse oximeters, convenes advisory committee

    The agency published a paper on improving the evaluation of pulse oximeters to take skin pigmentation into account.

    By • Nov. 17, 2023
  • 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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    LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

    Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of their own home.”

    By • Nov. 16, 2023
  • A depiction of computer hardware.
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    solarseven via Getty Images
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    FDA-ordered report tackles how to manage cybersecurity risks of legacy devices

    The report from MITRE proposes multiple actions for protecting older medical devices, including research into more modular devices and collecting data on cyber risks.

    By • Nov. 16, 2023
  • Vicarious Surgical plans to seek de novo clearance for its surgical robot.
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    Permission granted by Vicarious Surgical
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    Vicarious delays surgical robot as integration challenges, R&D cuts slow development

    Analysts at BTIG warned the company is “walking a very tight rope” and downgraded the stock.

    By • Updated Nov. 15, 2023
  • Two syringes are compared side by side. The one on the left is slightly shorter than the one on the right.
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    Retrieved from Food and Drug Administration.
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    Cardinal’s changes to disposable syringes trigger FDA Class I recall notice

    The problem is linked to 15 reports of delayed therapy and 13 reports of inaccurate dispensing.

    By • Nov. 15, 2023
  • Two devices say "McGrath Mac" on a square label. Some text in red points to where the devices' serial numbers are located.
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    Retrieved from Medtronic on October 05, 2023
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    Stolen Medtronic laryngoscopes deemed Class 1 recall

    Some of the defective devices turned up on Facebook Marketplace before the posting was taken down, the FDA said in the recall notice.

    By • Nov. 15, 2023
  • Abbott HeartMate 3 left ventricular assist device
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    Courtesy of Abbott
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    Abbott study links aspirin-free regimen to better outcomes in heart pump patients

    An accompanying editorial said the “data provide an opportunity to immediately improve the outcomes of patients implanted with contemporary LVADs.”

    By • Nov. 15, 2023
  • Boston Scientific's Farapulse pulsed field ablation PFA generator and catheter
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    Permission granted by Boston Scientific
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    Large registry study upholds safety findings for Boston Scientific’s Farapulse device

    The results, presented at the American Heart Association Scientific Sessions, showed a low rate of adverse events for the pulsed-field ablation treatment.

    By • Nov. 14, 2023
  • President Joe Biden signs a presidential memorandum that will establish the first-ever White House Initiative on Women’s Health Research.
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    Win McNamee/Getty Images via Getty Images
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    Biden initiative aims to accelerate women’s health research

    AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.

    By • Nov. 14, 2023
  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    Olympus receives Class I recall label for another bronchoscope safety issue

    The company's latest corrective action follows four reports of “endobronchial combustion” during procedures with its bronchoscopes.

    By • Updated Dec. 21, 2023
  • An injection pen containing the drug semaglutide lies on a white plate.
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    Douglas Cliff via Getty Images
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    Wegovy study details revive debate over GLP-1 impact on devices

    The data confirmed a cardiovascular benefit for heart patients and showed the drug could help pre-diabetic patients control their blood sugar.

    By • Nov. 13, 2023
  • 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 says customer data breached in cyber incident

    The company lowered its 2023 sales and earnings forecasts in response to the incident, which took some of its distribution systems offline.

    By • Nov. 13, 2023
  • A medical professional in a white suit and mask working on a tablet
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    Getty Images/Tassaphon Vongkittipong

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    Sponsored by ISACA

    A catalyst for quality: FDA’s Voluntary Improvement Program saves time, improves process and enhances patient outcomes

    Using ISACA's CMMI framework, medical device manufacturers have seen significant improvements, underscoring the program's positive influence on patient outcomes.

    Nov. 13, 2023
  • A Resmed sleep apnea machine
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    Courtesy of ResMed
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    Resmed overhauls C-suite, creating 3 posts and parting ways with 2 execs

    The company recently laid off 5% of its staff and stopped certain projects to lower operating costs.

    By • Nov. 13, 2023
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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
  • A person wearing safety goggles holds a pipette of fluid.
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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
  • 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 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
  • An oversized pair of scissors looms over seven workers sitting in office chairs suspended by strings.
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    mathisworks via Getty Images
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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
  • Becton Dickinson logo
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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