Medical Devices: Page 71

  • An X-ray image shows the lungs and the ribcage
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    the rads via Getty Images
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    GE Healthcare, MediView XR partner to launch augmented reality X-ray imaging system

    The companies are pitching the product as a response to physician demand for streamlined workflows and improved ergonomics.

    By • Nov. 30, 2022
  • 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 touts benefits of latest Evolut TAVR system in retrospective analysis

    Changes to the device improve alignment that is associated with improved coronary blood flow and valve hemodynamic performance.

    By • Nov. 30, 2022
  • 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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    Boston Scientific
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    Boston Scientific to buy Apollo Endosurgery for $615M as entry into endobariatric market

    The acquisition values Apollo shares at two-thirds above their closing price Monday, and may herald a new trend in medtech M&A, says an analyst.

    By • Nov. 29, 2022
  • A prototype of a linear collider in a CERN laboratory.
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    Courtesy of CERN
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    World’s largest particle physics laboratory backs push to transform cancer radiotherapy

    Scientists, researchers and physicians will develop a machine to use high-speed particles to attack tumors deep inside the human body.

    By • Nov. 29, 2022
  • A Baxter WatchCare bed
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    Courtesy of Hillrom/Baxter
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    Baxter recall of connected incontinence pads ranked by FDA as Class I event

    The recall was assigned to the highest risk category as it could affect medically necessary devices, including insulin pumps and fetal monitors.

    By • Nov. 28, 2022
  • A doctor puts a pulse oximeter on a patient's finger
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    Wavebreakmedia via Getty Images
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    Masimo’s pulse oximeter has no significant racial bias, study finds

    The company said the result reflects its use of four additional signal processing engines that cut the impact of factors including skin pigmentation.

    By • Nov. 28, 2022
  • The European Union flag.
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    artJazz via Getty Images
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    Europe faces 2024 bottleneck in device reapprovals as submissions slow

    While approval certificates for three-fourths of Europe’s medical devices will expire in 2024, a survey found no increase in the pace of submissions. 

    By • Nov. 28, 2022
  • A stock image of a calculator alongside financial numbers
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    atiatiati via Getty Images
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    Teleflex launches another round of restructuring

    Rising costs are pushing the device maker to incur restructuring liabilities of $31 million to $40 million.

    By • Nov. 23, 2022
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    Mario Tama via Getty Images
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    ‘Tripledemic’ concerns spur FDA to issue emergency authorization for flu-COVID-19 combination test

    Experts have warned “a viral hurricane is making landfall” as cases of RSV, influenza and COVID-19 rise simultaneously.

    By • Nov. 23, 2022
  • Philips CPAP machine
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    N/A via Getty Images
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    Philips respirator recall reaches 260 reported deaths, FDA says

    The agency has received 90,000 medical device reports related to foam problems with Philips’ recalled sleep apnea devices and ventilators.

    By • Updated Nov. 23, 2022
  • Mazor robotic system
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    Permission granted by Medtronic
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    Medtronic lowers full-year forecast, citing drop in procedure growth

    A slower-than-expected recovery in certain procedures, including TAVR and spinal cord stimulation, curbed quarterly profit and revenue.

    By • Nov. 22, 2022
  • A man checks his phone in an Apple retail store in Grand Central Terminal in New York City.
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    Drew Angerer/Getty via Getty Images
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    State AGs urge Apple to protect consumers’ reproductive health data

    Apps holding sensitive health data should be required to delete nonessential information and clearly inform consumers what information they share with parties such as law enforcement, the 10 state attorneys general said.

    By Rebecca Pifer • Nov. 22, 2022
  • A patient recovers after a total knee replacement surgery.
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    Sasirin Pamai via Getty Images
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    Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement

    The new joint uses anatomical data in combination with 3D printing to try to directly mimic the architecture of human spongy bone.

    By • Nov. 22, 2022
  • Three pair of Apple Air Buds Pro which may be able to be used instead of hearing aids
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    Courtesy of Apple
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    Apple earbuds show promise as hearing aids in clinical trial

    The earbuds performed comparably to hearing aids in terms of speech perception in quiet environments.

    By • Nov. 22, 2022
  • a picture of a red stethoscope on top of a US billed money.
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    Adeline Kon/Healthcare Dive/MedTech Dive
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    Q3 Earnings Wrap: Bumpy time for medtech with inflation, FX, supply woes

    Macroeconomic pressures were a persistent theme for the industry, with workforce reductions a part of the fallout for some companies.

    By • Nov. 21, 2022
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    Nick Jio/Unsplash
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    Apple Watch app for monitoring Parkinson’s symptoms earns FDA clearance

    The technology has been validated in a clinical trial, positioning h2o to create an app that enables real-time sharing of Parkinson’s symptom data.

    By • Nov. 21, 2022
  • Argonne National Laboratory seen from above
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    NNehring via Getty Images
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    How wearable devices with skin-like stretchability may pave way for better health tracking

    An AI-enabled prototype based on the stretchable technology was more than 95% effective at correctly identifying electrocardiogram signals.

    By • Nov. 21, 2022
  • Professional photo of Dev Kurdikar
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    Permission granted by Embecta
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    Q&A

    Friday Q&A: Embecta CEO talks BD spinoff, future of diabetes devices

    Dev Kurdikar spoke with MedTech Dive about developing an insulin pump for patients with Type 2 diabetes and what’s next for the firm.

    By • Nov. 18, 2022
  • Semiconductor
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    Michelle Rock/MedTech Dive, data from Getty Images
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    AdvaMed pushes Biden to use $52B chip program to support medtech supply chains

    The group wants agencies to coordinate with the medtech industry to ensure investments are directed toward “technologies that power medical devices.” 

    By • Nov. 18, 2022
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips’ ventilator woes grow as FDA issues alert over replacement foam

    Replacement noise reduction material in Trilogy ventilators can block the air inlet and let trace amounts of particulate matter into the air pathway.

    By • Nov. 18, 2022
  • Rendering of a spiral-shaped catheter with four electrodes
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    Permission granted by Medtronic
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    Medtronic’s renal denervation treatment ‘still a viable therapy’ despite study miss, doctors say

    While the study missed its primary endpoint, the surgery likely will be an option for patients with drug-resistant hypertension.

    By • Nov. 17, 2022
  • A person sits in front of a plate of food, holding a smartphone. They're wearing a patch on their left arm.
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    Courtesy of Insulet Corp.
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    Insulet warns Omnipod 5 insulin pump charge issue may cause fire

    Rapid sales growth at the company has come amid safety problems involving some of its devices.

    By • Nov. 17, 2022
  • A Medtronics diabetes device
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    Courtesy of https://news.medtronic.com/MiniMed-R-670G-Hybrid-Closed-Loop-System#assets_34137_21-122
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    Medtronic doubles wear time of insulin pump infusion sets

    The company calculated users of its extended-wear system will change their devices 75 fewer times, resulting in annual savings of more than $1,000.

    By • Nov. 16, 2022
  • Person uses VR headset
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    Photo by fauxels from Pexels

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    Penumbra expands VR rehabilitation platform with lower body sensors

    Adding lower body sensors will enable the company to target a wider range of health conditions.

    By • Nov. 16, 2022
  • A row of oversized NFL helmets.
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    Duane Prokop/Getty Images via Getty Images
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    NFL expands program to use sensor-loaded mouthguards to gather head impact data

    Data from the sensors could show what the human head experiences during an impact, improving efforts to reduce the incidence of concussions in football.

    By • Nov. 15, 2022