Medical Devices: Page 2


  • A large machine on a wheels with an attached screen.
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    Courtesy of Beckman Coulter
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    Beckman Coulter receives FDA warning letter

    Inspectors found fault with quality practices at a facility that makes immunoassay analyzer instruments and tests.

    By April 5, 2024
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    Sarah Silbiger via Getty Images
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    Smiths Medical recalls thousands of ventilators over fault linked to 8 serious injuries

    A problem with the devices can cause patients to receive the wrong amount of ventilation or too little oxygen, the FDA said in a recall notice.

    By April 5, 2024
  • Trendline

    The EU Medical Device Regulation

    While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems with continued extensions and outstanding questions still in play.

    By Medical More staff
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    Mario Tama via Getty Images
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    J&J to acquire Shockwave Medical for $13.1B

    The deal comes just over a week after The Wall Street Journal reported that the companies were discussing a merger.

    By Updated April 5, 2024
  • A screen shows the number "92" as a sepsis risk score, with "Very High Risk Category" at the top of the screen.
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    Permission granted by Prenosis
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    FDA grants de novo nod to AI tool for detecting sepsis

    Prenosis CEO Bobby Reddy Jr. told Medical More the company sees third-party validation as important, with the FDA having clarified that certain decision support tools should be regulated as medical devices.

    By April 4, 2024
  • A picture of Eko Health's stethoscope AI system.
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    Permission granted by Eko Health
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    Eko wins FDA nod for AI to detect sign of heart failure using stethoscope

    The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.

    By April 4, 2024
  • Exterior of FDA headquarters
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    Courtesy of U.S. Food and Drug Administration
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    Teleflex catheterization kit recall linked to 10 injuries, 1 death

    Nearly 335,000 devices were recalled due to safety issues, which may cause damage to blood vessel walls, artery blockage or death.

    By April 4, 2024
  • Digital code data numbers and secure lock icons on hacker's hands working with keyboard computer on dark blue tone background.
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    Techa Tungateja via Getty Images
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    Deep Dive

    As cyberattacks on healthcare persist, can the FDA’s new device regs hold up?

    Revamped regulations to thwart hackers are a big step forward, but issues such as legacy devices and reliance on software patches pose lingering challenges.

    By April 3, 2024
  • A picture of Baxter's Novum IQ large volume infusion pump
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    Permission granted by Baxter
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    Baxter receives FDA clearance for delayed Novum IQ infusion pump

    The clearance ends a three-year back-and-forth with the FDA to get the product to market.

    By April 2, 2024
  • An image of Abbott's TriClip device to repair the tricuspid valve.
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    Permission granted by Abbott
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    Abbott nets FDA approval for Triclip

    The transcatheter tricuspid valve repair device will compete against Edwards Lifesciences’ Evoque system.

    By April 2, 2024
  • A blue and white reader next to a cartridge that says i-STAT TBI.
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    Permission granted by Abbott
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    Abbott wins FDA clearance for bedside blood concussion test

    The clearance is a step towards using the test in non-healthcare settings, such as sporting events, Abbott said.

    By April 2, 2024
  • 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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    Infutronix pulls infusion pumps from US after nearly 3,700 complaints

    The company listed six issues that can cause the pumps to stop infusions and otherwise malfunction.

    By April 2, 2024
  • 3M headquarters in Minnesota
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    Courtesy of 3M.

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    3M spins out Solventum

    The new company will need to work through debt from the spinoff and sole-source arrangements with 3M.

    By April 1, 2024
  • Head shot of Quentin Koffey, Politan Capital Management
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    Permission granted by Politan Capital Management
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    Masimo faces another proxy challenge from Politan Capital

    The activist shareholder seeks two more seats on Masimo’s board, after both candidates it nominated last spring were voted in.

    By April 1, 2024
  • Justin Barad wears scrubs and holds a VR headset
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    Permission granted by Osso VR
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    Osso VR to lay off 67 people at corporate HQ

    Art and illustration jobs were heavily affected by the layoffs, which will be complete by May 27.

    By April 1, 2024
  • Professional photo of Aldo Denti
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    Permission granted by Johnson & Johnson
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    Q&A

    J&J’s Aldo Denti on digital technology in orthopedics

    The chairman of J&J subsidiary DePuy Synthes talked about how surgical robots and other technologies have contributed to procedures moving to outpatient facilities.

    By Updated April 1, 2024
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Roche wins FDA approval for first molecular malaria blood donor screening test

    The company is pitching the test as a way to improve the safety and availability of blood.

    By March 28, 2024
  • 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 in talks to buy Shockwave Medical: WSJ

    The healthcare giant could follow up its $16.6 billion acquisition of Abiomed with another deal for a heart device company, the WSJ reported Tuesday.

    By March 27, 2024
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images
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    FDA hits Renovo with warning letter over reprocessed medical devices

    The letter accuses Renovo of adding models other than the ones covered by its 510(k) clearances.

    By March 27, 2024
  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    Neuronetics wins FDA clearance for device to treat adolescents with depression

    William Blair analysts called the clearance a positive surprise, explaining that the FDA has denied several therapies in the patient population.

    By March 27, 2024
  • A photo of a sign showing the Food and Drug Administration logo
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    Sarah Silbiger via Getty Images
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    FDA re-issues ban on electric shock devices

    The agency tried to ban the devices in 2020, but a federal appeals court overturned the decision.

    By March 26, 2024
  • Abbott's Assert implantable cardiac monitor
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    Courtesy of Abbott
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    Abbott receives CE mark for 6-year insertable cardiac monitor

    The device can continuously monitor a patient’s heart rhythms for either three or six years, depending on users’ needs.

    By March 26, 2024
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
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    Courtesy of Johnson & Johnson
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    J&J files for FDA approval of Varipulse pulsed field ablation platform

    The company wants to catch up with rival PFA systems from Medtronic and Boston Scientific that have already received FDA authorization.

    By March 26, 2024
  • Masimo CEO Joe Kiani looks over the countryside
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    Courtesy of BusinessWire/Masimo
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    Masimo to split off consumer business

    The decision comes two years after the pulse oximetry specialist acquired Sound United for its audio brands in a $1 billion deal.

    By March 25, 2024
  • 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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    Vyaire Medical recalls Airlife resuscitators over defect linked to 2 death reports

    The recall covers respiratory support devices made in 2017 or earlier that can fail to provide enough ventilation.

    By March 22, 2024
  • Professional photo of Katherine Truppi
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    Permission granted by Stryker
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    Q&A

    Stryker’s next head of joint replacement talks about new revision, robotics products

    Katherine Truppi will become president of Stryker’s joint replacement business on March 31 after more than 20 years at the company.

    By March 22, 2024