Medical Devices: Page 66
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GE HealthCare oxygen sensor recall gets Class I label from FDA
GE warned that the sensors can limit the effectiveness of cardiac defibrillation, expose patients to electrical currents, or give inaccurate blood oxygen readings.
By Nick Paul Taylor • July 31, 2023 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher eyes $450M in cost cuts due to slowing demand
The pullback in spending will include layoffs and lower investments in some areas of the business, company executives said.
By Susan Kelly • July 28, 2023 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 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 -
Sara Silbiger via Getty Images
FDA shares draft guidance on studying medtech treatments for opioid use disorder
The FDA aims to address challenges including inaccurate self-reported drug use, missing data and the need to show the durability of the treatment.
By Nick Paul Taylor • July 28, 2023 -
Courtesy of Dexcom
Dexcom hails CGM share gains as driver of 25% revenue growth in Q2
International market share gains and expanding coverage in the U.S. led the CGM maker to raise its revenue forecast for 2023.
By Nick Paul Taylor • July 28, 2023 -
Courtesy of Abbott Laboratories
Abbott recall of heart catheter categorized as Class I event
Abbott plans to win approval for a modified steerable product and bring it to market as a replacement for the recalled device.
By Nick Paul Taylor • July 27, 2023 -
Permission granted by Boston Scientific
Boston Scientific raises full-year forecast again, fueled by strong Q2
The company boosted its outlook for the second consecutive quarter and said patients face waitlists for procedures using its devices.
By Susan Kelly • July 27, 2023 -
Courtesy of https://www.edwards.com/devices/heart-valves/transcatheter-SAPIEN-3-Ultra
Edwards’ TAVR results hurt by pandemic aftereffects and competition in Q2
Staffing is still not where Edwards “would have projected to be in absence of the pandemic.”
By Nick Paul Taylor • July 27, 2023 -
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Teleflex to expand urology portfolio with $600M acquisition
The company reached an agreement to buy Palette Life Sciences, as it looks to grow through acquisitions.
By Elise Reuter • July 26, 2023 -
Regulatory specialist pleads guilty to forging FDA clearance letters
The former employee of B. Braun’s Aesculap division admitted creating the letters on FDA letterhead and forging an agency official’s digital signature.
By Susan Kelly • July 26, 2023 -
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FDA adopts new sterilization standard to support switch from ethylene oxide
The regulator said it added the alternative sterilization method to its database in response to pressure to reduce EtO use and to support supply chain resiliency.
By Nick Paul Taylor • July 26, 2023 -
Courtesy of GE Healthcare
GE HealthCare plans cost cuts, raises earnings forecast
The company plans to improve its margins by cutting down on service agreements and by driving more efficiency in manufacturing and supply chain.
By Elise Reuter • July 25, 2023 -
Permission granted by Inspire Medical Systems
Inspire Medical hires Medtronic veteran as new strategy chief
Carlton Weatherby has been tapped to help the sleep apnea implant maker scale up its business.
By Susan Kelly • July 24, 2023 -
Sarah Silbiger via Getty Images
FDA improves 510(k) turnaround times, but PMA waits hit record high: analysis
The time it took for the FDA to reach 510(k) decisions decreased by 24 days, but the agency is still working through a pandemic-driven backlog of premarket approval applications.
By Nick Paul Taylor • July 24, 2023 -
Permission granted by Becton Dickinson
BD gains FDA clearance to relaunch Alaris infusion pump after recalls
The company will fix or replace older devices still in use at hospitals as it ramps up to resume sales in its market-leading infusion business.
By Susan Kelly • July 24, 2023 -
Courtesy of Intuitive Surgical
Bariatric surgery slowdown nips Intuitive Surgical’s Q2 procedure growth
New weight-loss drugs are eroding demand for surgical procedures that employ the company’s robotic systems.
By Susan Kelly • July 21, 2023 -
Permission granted by Becton Dickinson
OpinionA novel approach to IV access
Improvements in IV catheters can lead to better, more compassionate care, says Joseph Smith, BD’s chief scientific officer.
By Joseph Smith • July 20, 2023 -
Courtesy of Abbott
Abbott Q2 net profit falls as weaker COVID test sales drag on revenue
Stronger medical device sales and a recovery in the infant formula business partly offset the impact of reduced COVID-19 testing.
By Susan Kelly • July 20, 2023 -
Mario Tama via Getty Images
J&J earnings a ‘positive early indicator’ for medtech in Q2: analyst
The company raised its revenue and earnings forecast for the year, driven by new products and global procedure growth.
By Elise Reuter • July 20, 2023 -
Courtesy of Abiomed/J&J
Four deaths attributed to interference between Abiomed’s heart pump and TAVR stents
There’s a risk that the valve implants can interact with the company’s Impella heart pumps, breaking the motor.
By Elise Reuter • Updated July 28, 2023 -
Courtesy of Medtronic
Medtronic recalls nearly 350,000 defibrillators for risk of reduced shock
The implantable devices may fail to deliver an electric shock to restore normal heart rhythm when needed, which could lead to a serious injury or death, the FDA said.
By Susan Kelly • July 18, 2023 -
Courtesy of Masimo
Masimo plans cost cuts as Q2 revenue falls short of expectations
Shares of the patient-monitoring device maker dropped 22% after it said hospital orders for its equipment were delayed and demand for consumer products softened.
By Susan Kelly • July 18, 2023 -
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Hearing aids fail to improve cognition in randomized trial, but subgroup analysis offers hope
While there were no positive effects observed in healthy older adults, a smaller analysis pointed to a difference in those at higher risk of cognitive decline.
By Nick Paul Taylor • July 18, 2023 -
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Big Health buys Limbix to add adolescent depression app to digital therapeutic portfolio
The phone-based treatment, SparkRx, uses self-guided, cognitive behavioral therapy to teach skills such as mood tracking.
By Nick Paul Taylor • July 18, 2023 -
Wallpaper Flare
ViewRay files for Chapter 11 bankruptcy
The company, which makes an MRI-guided radiation therapy system, intends to sell all or some of its assets.
By Elise Reuter • July 17, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA provides safety update on hernia repair mesh as medtech companies face lawsuits
The FDA’s analysis of adverse event reports describes problems including pain, injury and disability.
By Nick Paul Taylor • July 17, 2023
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