Medical Devices: Page 61


  • A reader showing a blood glucose measurement next to a small, circular  device
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    Permission granted by Abbott
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    Abbott boosts organic sales outlook as device demand accelerates

    A rebound in surgical procedure volumes as hospital staffing improved at the start of the year partially offset a steep drop in COVID-19 testing sales.

    By April 19, 2023
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    Stock via Getty Images
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    AFib study shows no effect on outcomes from 1-year delay of catheter ablation

    Early treatment could be a boon for medtech companies such as Boston Scientific and Medtronic but is potentially challenging for healthcare systems. The new study suggests waits of up to a year will not harm patients.

    By April 19, 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
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    VCG / Stringer via Getty Images
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    Intuitive posted 26% jump in robotic procedures in Q1 as hospitals chipped away at backlog

    The company experienced “some backlog effect from patients generally returning to more normalized healthcare routines, given the effect of the pandemic over several years.”

    By April 19, 2023
  • Ashley McEvoy, J&J's  worldwide chairman of Medical Devices
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    Permission granted by Johnson & Johnson
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    J&J raises forecast as medtech procedures recover

    The company’s medical device business grew by more than 7% in the first quarter.

    By April 18, 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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    Post-approval modification of high-risk devices linked to 30% jump in recall risk: study

    The authors suggest improved post-marketing surveillance systems may be needed to mitigate risks to patient safety.

    By April 18, 2023
  • Professional photo of Frank Chan
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    Permission granted by Medtronic
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    What medtech startups need to know about remote monitoring

    Four medtech executives talked about the future of hospital at home, and the difference between consumer devices and medical devices, in an event hosted by the Colorado Bioscience Association.

    By April 17, 2023
  • LivaNova Essenz HLM
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    Courtesy of LivaNova
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    LivaNova CEO quits as firm announces higher-than-expected preliminary earnings

    Analysts from Needham and Stifel had opposite takes on how McDonald’s departure will affect the company, which has struggled in recent years to bring new products to market. 

    By Peter Green • April 17, 2023
  • A grey reader shows a blood glucose reading, next to a white circular device
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    Permission granted by Abbott
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    Abbott gets clearance for Libre 3 reader, opening path to Medicare coverage

    With a standalone reader, Abbott said it is working to make the FreeStyle Libre 3 system available to people covered by Medicare. 

    By April 17, 2023
  • Woman comparing result of glucose level check on the traditional glucometer and on the mobile phone
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    Shutterstock/Lukasz Pawel Szczepanski

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    Sponsored by Esper

    Overcome the top 5 device management challenges of remote patient care with ease

    As more organizations adopt RPM, they’re facing increasingly complex challenges managing, updating and securing their devices.

    April 17, 2023
  • Financial details under magnifying glass
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    echoevg via Getty Images
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    Proxy adviser backs diabetes device developer Sernova in fight against activist investors

    Institutional Shareholders Services said the activist investors “failed to present a detailed explanation” of their case and recommended that shareholders vote for Sernova’s director nominees. 

    By April 17, 2023
  • A photo of Sam Ajizian
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    Permission granted by Medtronic
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    Q&A

    Friday Q&A: Medtronic’s Ajizian talks connected care ahead of unit spinoff

    From supporting AI-driven medical interventions to freeing up providers from administrative tasks, remote patient monitoring is raising the bar for care, says Medtronic’s CMO for patient monitoring.

    By April 15, 2023
  • Close up of a patient monitor with a patient in a bed and a doctor in the background.
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    Courtesy of Medtronic
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    Medtronic, 6 months after proposing patient monitoring spinoff, remains mum on separation plan

    A standalone entity could achieve faster growth, even though recent spinoffs in the medtech sector have produced mixed results, analysts say.

    By April 14, 2023
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    Courtesy of Philips
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    Fewer Philips replacement devices have reached patients than counted, FDA says

    The agency raised concerns that the discrepancy could affect the estimated wait times for patients needing a replacement sleep apnea device.

    By April 14, 2023
  • A medtronic mobile lab with a mockup operating room for training
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    Courtesy of https://news.medtronic.com/newsroom-medtronic-hits-the-road-mobile-labs
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    Medtronic targets June closure of Epix facility, will lay off 59 employees

    The company had bought Epix for a catheter-based, temperature-controlled cardiac ablation system designed to treat patients with irregular heartbeats.

    By April 14, 2023
  • The Nasdaq MarketSite is seen on October 12, 2022 in New York City.
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    Michael M. Santiago via Getty Images
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    Digital surgery firm Surgalign faces delisting by Nasdaq for shareholder equity noncompliance

    The exchange has given Surgalign 45 days to submit a plan to regain compliance.

    By April 14, 2023
  • A lexie/Bose OTC hearing aid held in a person's hand
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    Courtesy of Walgreens
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    OTC hearing aid matches performance of audiologist-fitted device in small trial

    People who used an over-the-counter hearing aid for six weeks saw similar results to people who used an audiologist-fitted device, suggesting less costly, self-fitted hearing aids could be an option. 

    By April 13, 2023
  • The Wall Street Bull srrounded by passing people
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    Spencer Platt/Getty via Getty Images
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    Medtech sector poised for growth as healthcare staffing tops pre-COVID levels: KeyBanc

    The analysts are “leaning into increased medtech exposure” after determining that several challenges that have constrained the industry are easing.

    By April 13, 2023
  • Close up of a knee implant, showing the stem, which includes a gray extension.
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    Permission granted by Zimmer Biomet
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    Zimmer’s ‘smart knee’ implant may qualify for new technology payments from CMS

    If finalized, the add-on payments would help cover the cost of the sensor technology included in the company’s Persona IQ knee implants.

    By April 12, 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 starts device sterilization pilot program to help industry adapt to EtO emission clampdown

    The FDA “recognizes the need to facilitate more timely changes” amid a push to cut EtO emissions and constraints on the supply of radioactive cobalt.

    By April 12, 2023
  • EPA map of cancer risk at Ethylene plant of Benton Dickson
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    EPA. (2022). "https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/forms/columbus-nebraska-becton-dickinson-pharmaceutical" [Photo]. Retrieved from EPA.gov.
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    Medical device groups say ‘the stakes are high’ with new EtO regulations

    AdvaMed, which represents medical device companies, warned that patients could face treatment delays if sterilization facilities close.

    By April 11, 2023
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    Brian Tucker
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    EPA to limit ethylene oxide emissions from medical device sterilizers

    The agency proposed new emissions limits that device sterilization companies would have 18 months to meet.

    By April 11, 2023
  • A GE Healthcare C-arm imaging device
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    Courtesy of GE Healthcare
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    GE HealthCare faces ‘competition from all angles’ that could constrain growth: analysts

    BTIG lists 20 companies as competitors to GE HealthCare, including China’s Shenzhen Mindray Bio-Medical Electronics and Shanghai United Imaging Healthcare.

    By April 11, 2023
  • letters m and a made with wood building blocks
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    Maks_Lab via Getty Images
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    Medtech buyouts by private equity in Q4 shed light on deal-making trends in 2023: report

    Medtech companies are continuing to spin off assets to realign portfolios, creating opportunities for private equity firms to buy businesses and exit existing investments.

    By April 11, 2023
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    Courtesy of Philips
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    Philips recalls 1,200 reworked sleep apnea devices over fault that can cause therapy failure

    The problems keep mounting for Philips, as recently repaired respirators now need to be fixed in a recall the FDA has labeled a Class I event.

    By April 10, 2023
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    Brian Tucker
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    EPA proposes stricter ethylene oxide pollutant rules for chemical makers

    Further EPA proposals involving medical device sterilization plants are expected to be forthcoming.

    By April 7, 2023