Medical Devices


  • Exterior view of a building with columns and a sign that says "Cook."
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    Courtesy of Cook Medical
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    Cook Medical wins contract to supply implants to US Defense Department

    Through the agreement, Cook will provide its Zilver PTX drug-eluting peripheral stent, Zenith aortic endografts and other implantable devices.

    By April 12, 2024
  • A headshot of Dr. Nadim Geloo
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    Permission granted by Abbott
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    Q&A

    Abbott’s Nadim Geloo on Triclip’s US launch, Edwards competition

    The senior medical director for structural heart discussed the Triclip rollout, Edwards’ rival tricuspid treatment and Abbott’s aortic valve clinical trial.

    By April 12, 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 MedTech Dive staff
  • A picture of the Apple Vision Pro headset at a conference event.
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    Justin Sullivan/Getty Images via Getty Images
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    Osso VR brings surgery training app to Apple Vision Pro

    Users can virtually walk through the steps of two orthopedic procedures: total knee replacement and carpal tunnel release.

    By April 12, 2024
  • Patient's view of dentist holding two dental instruments.
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    Peter Macdiarmid via Getty Images
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    Steris to sell dental segment for $787.5M

    Divesting the business will allow Steris to repay debt and focus on its core markets of healthcare, pharma and medtech.

    By April 11, 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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    FDA expands import alert to block all plastic syringes from Chinese manufacturer

    The agency increased the blockade because Jiangsu Shenli Medical Production failed to meet device quality system requirements.

    By April 11, 2024
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    Courtesy of Philips
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    Philips restricted from selling respiratory machines in DOJ consent decree

    The agreement, filed Tuesday, also has export restrictions to ensure U.S. patients receive remediated devices in a timely manner.

    By April 9, 2024
  • A metal, cylinder shaped hollow device has small electrodes around the sides.
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    Permission granted by Synchron
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    Synchron launches patient registry to prepare for brain implant trial

    The startup, which rivals Neuralink, is developing brain-computer interface technology that lets people control electronic devices hands-free.

    By April 9, 2024
  • Persons in physician garb demonstrating replacement knee joint
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    Sittithat Tangwitthayaphum via Getty Images
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    Robotic knee surgery study revives debate over procedure’s benefits

    As robotic assistance gains in popularity, new research has found no advantage over the conventional approach in reducing the need for knee replacement revision surgeries.

    By April 9, 2024
  • A picture of MMI's Symani robotic surgery system.
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    Courtesy of MMI
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    MMI receives de novo nod for microsurgery robot

    Medical Microinstruments said the system could increase the number of physicians who can perform complicated microsurgical procedures.

    By April 9, 2024
  • Evolut™ PRO+ TAVR System for Treatment of Symptomatic Severe Aortic Stenosis Patients
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    Permission granted by Medtronic
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    Medtronic beats Edwards on valve dysfunction in TAVR study

    In a head-to-head clinical trial, Medtronic linked its device to a lower rate of valve dysfunction than Edwards’ rival product in a subpopulation of patients.

    By April 8, 2024
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    Stock via Getty Images
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    Physicians ask FDA to revoke approval of DNA test for opioid addiction

    Physicians said the test is based “on old genetic studies that have largely been abandoned” and could exacerbate the opioid crisis.

    By April 8, 2024
  • 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
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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 MedTech Dive 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