Medical Devices: Page 59

  • Ashley McEvoy, J&J's worldwide chairman of Medical Devices
    Image attribution tooltip
    Permission granted by Johnson & Johnson
    Image attribution tooltip

    J&J MedTech Chairman Ashley McEvoy to step down

    McEvoy is leaving the company after 27 years to pursue other opportunities. Tim Schmid will now lead the MedTech business.

    By • Updated Oct. 24, 2023
  • the FDA Headquarters
    Image attribution tooltip
    Sara Silbiger via Getty Images
    Image attribution tooltip

    Olympus recall of abdominal insufflation devices linked to reports of 10 serious injuries, 1 death: FDA

    The Food and Drug Administration labeled the recall a Class I event.

    By • Updated Oct. 30, 2023
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline➔
    Image attribution tooltip
    Courtesy of Intuitive Surgical
    Image attribution tooltip
    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
  • An illustration of the Medtronic Aurora extravascular defibrillator
    Image attribution tooltip
    Permission granted by Medtronic
    Image attribution tooltip

    Medtronic gains FDA approval for extravascular defibrillator

    The device to treat abnormal heart rhythms is designed to avoid risks associated with traditional implantable cardioverter defibrillators that have leads running through the veins to the heart.

    By • Oct. 23, 2023
  • A person sits in front of a plate of food, holding a smartphone. They're wearing a patch on their left arm.
    Image attribution tooltip
    Courtesy of Insulet Corp.
    Image attribution tooltip

    Insulet receives FDA clearance for Omnipod 5 iPhone app

    The application removes the need for patients with iPhones to carry a separate controller to manage bolus dosing.

    By • Oct. 23, 2023
  • A Philips factory
    Image attribution tooltip
    Patrik Stollarz / Staff via Getty Images
    Image attribution tooltip

    Philips’ orders fall in Q3, overshadowing sales growth and return to sleep apnea market

    CEO Roy Jakobs said during a third-quarter earnings call that there is still “significant demand” for the company’s sleep apnea products.

    By • Oct. 23, 2023
  • Image attribution tooltip
    VCG / Stringer via Getty Images
    Image attribution tooltip

    Intuitive’s Q3 sales miss estimates as robot leasing, China demand weigh

    The robotic surgery leader’s overall procedure growth, however, exceeded market expectations.

    By • Oct. 20, 2023
  • Scientist wearing safety uniform and glove under working water analysis and water quality by get waste water to check case in laboratory is environment pollution problem.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    AdvaMed CEO warns Congress of supply shortages from EtO, PFAS regulations

    The trade group leader called for changes to the EPA’s proposals, while a scientist with UCSF said lawmakers should turn to science free of vested financial interests. 

    By • Oct. 20, 2023
  • An image of the Edwards Sapien 3 Ultra Resilia transcatheter aortic heart valve
    Image attribution tooltip
    Courtesy of https://www.edwards.com/devices/heart-valves/transcatheter-SAPIEN-3-Ultra
    Image attribution tooltip

    Physicians forecast Edwards’ 5-year data will have limited impact on low-risk TAVR market

    Some doctors think TAVR may perform numerically worse but see little impact on the market unless there is a statistically significant result.

    By • Oct. 20, 2023
  • Anumana CEO Maulik Nanavaty wears a blue jacket and white shirt.
    Image attribution tooltip
    Courtesy of Anumana
    Image attribution tooltip

    Anumana names Boston Scientific veteran Maulik Nanavaty as CEO

    Nanavaty has taken up the post after spending 18 years at Boston Scientific, where he held senior roles in interventional cardiology and neuromodulation.

    By • Oct. 20, 2023
  • A circular device with a metal mesh around it.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    Edwards receives CE mark for tricuspid valve replacement

    The company expects to gain U.S. approval late next year.

    By • Oct. 19, 2023
  • A respiratory therapist checks on a patient at a medical center in Chicago, Illinois.
    Image attribution tooltip
    Scott Olson via Getty Images
    Image attribution tooltip

    Supply disruptions are delaying surgeries and compromising patient care, survey finds

    A patient safety nonprofit used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages.

    By • Oct. 19, 2023
  • A person holds the company's miniature robot in a hand.
    Image attribution tooltip
    Courtesy of Interventional Systems
    Image attribution tooltip

    Interventional Systems gets second 510(k) clearance for miniature robot

    The FDA cleared the Micromate system to use CT navigation in procedures such as biopsies and ablations.

    By • Oct. 19, 2023
  • Exterior of FDA headquarters
    Image attribution tooltip
    Courtesy of U.S. Food and Drug Administration
    Image attribution tooltip

    FDA finalizes COVID-era guidance, extending flexibility for some remote monitoring devices

    The agency shortened its list of devices that can continue to undergo limited modifications without 510(k) filings.

    By • Oct. 19, 2023
  • A person wearing a blue glove puts a syringe into a red medical waste container.
    Image attribution tooltip
    Courtesy of BD
    Image attribution tooltip

    BD recycles 40,000 pounds of medical waste in circular economy pilot project

    The collaborators assessed the feasibility of recycling medical waste such as plastic syringes.

    By • Oct. 18, 2023
  • Abbott FreeStyle Libre 3 sensor
    Image attribution tooltip
    Courtesy of Abbott
    Image attribution tooltip

    Abbott raises outlook amid strong Q3, sees momentum into 2024

    Sales of the FreeStyle Libre continuous glucose monitor rose nearly 31% despite investor worries about the potential impact of weight-loss drugs on demand.

    By • Oct. 18, 2023
  • tuberculosis scan
    Image attribution tooltip
    Spencer Platt via Getty Images
    Image attribution tooltip

    Siemens Healthineers partners to improve tuberculosis screening using AI

    The company will work with the Global Fund to Fight AIDS, Tuberculosis and Malaria, providing free licenses and helping to integrate AI-enabled processes into clinicians’ workflows.

    By • Oct. 18, 2023
  • Johnson & Johnson's campus in Irvine, California
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    J&J to restructure orthopedics business

    The company announced the two-year restructuring in its third-quarter earnings call. It expects the changes to accelerate growth and enhance profitability, CFO Joe Wolk said.

    By • Oct. 17, 2023
  • Boxes of the diabetes drug Ozempic rest on a pharmacy counter on April 17, 2023 in Los Angeles, California.
    Image attribution tooltip
    Mario Tama / Getty via Getty Images
    Image attribution tooltip

    Medtech can cope with GLP-1s but ‘fear and doubt’ suppressing stocks: analysts

    J.P. Morgan analysts caution that stocks could continue to suffer through 2024 and 2025.

    By • Oct. 17, 2023
  • newborn screening
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    GE HealthCare cuts formaldehyde levels in neonatal incubators with revised process

    The FDA previously alerted healthcare providers to the potential for neonatal incubators to emit airborne chemicals.

    By • Oct. 17, 2023
  • Four people sit on a stage, and one of them speaks into a microphone.
    Image attribution tooltip
    Elise Reuter/MedTech Dive
    Image attribution tooltip

    FDA: ‘We have had a very loud voice’ on EtO

    The agency said it is working closely with the Environmental Protection Agency, which is slated to implement a final rule in March limiting ethylene oxide emissions for medical device sterilizers.

    By • Oct. 16, 2023
  • Masimo CEO Joe Kiani looks over the countryside
    Image attribution tooltip
    Courtesy of BusinessWire/Masimo
    Image attribution tooltip

    Masimo wins de novo authorization for measure of high blood oxygen levels

    The ORi device is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation.

    By • Oct. 16, 2023
  • Image attribution tooltip
    Mario Tama via Getty Images
    Image attribution tooltip

    J&J receives 510(k) clearance for foot fixation device, targets growing bunion market

    The clearance comes shortly after Stryker introduced a minimally invasive system for treating bunions.

    By • Oct. 16, 2023
  • Artificial intelligence in healthcare
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024

    The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.

    By • Oct. 13, 2023
  • A person looks at a black and white image on a screen as they hold an ultrasound device to another person's chest.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    GE HealthCare wins $44M BARDA contract to develop AI-enabled ultrasound

    BARDA sees challenges with using ultrasound in trauma care, leading it to task GE HealthCare with developing an automated 4D system and AI algorithms.

    By • Oct. 13, 2023
  • Image attribution tooltip
    Flickr: Eoghan OLionnain
    Image attribution tooltip

    European Commission orders Illumina to divest Grail

    The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.

    By • Oct. 12, 2023