Medical Devices


  • Intuitive Surgical's da Vinci 5 robotic system.
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    Courtesy of Intuitive Surgical
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    Intuitive’s rollout of new da Vinci 5 robot steals Q1 spotlight

    While Intuitive has already placed eight new surgical robots, executives cautioned system placements could be choppy in the coming months.

    By April 19, 2024
  • A view of Baxter International's production facility in the state of North-Rhine Wetsphalia on January 15, 2021 in Halle, Germany.
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    Sascha Schuermann via Getty Images
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    Spinoffs, sales and tuck-ins top medtech deal priorities: Moody’s

    After J&J’s $13.1 billion purchase of Shockwave Medical, Moody’s analysts see the potential for other larger pick-ups “if interest rates substantially decrease.”

    By April 19, 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
  • A picture of a computer screen with Scopio Labs' bone marrow analysis software on it.
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    Permission granted by Scopio Labs
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    Scopio Labs wins de novo nod for bone marrow analysis software

    Scopio can now add the application to its imaging platforms that allow users to view blood samples digitally rather than under a microscope.

    By April 18, 2024
  • Anne Wojcicki speaking event
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    Brad Barket via Getty Images
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    23andMe CEO plans to take company private

    Anne Wojcicki wants to buy all outstanding shares of the DNA testing firm, which has seen its stock slump in recent years.

    By April 18, 2024
  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Boston Scientific recalls blood-blocking agent linked to 2 deaths

    Seven injuries and 11 incidents were also associated with the safety issue.

    By April 18, 2024
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    Patrik Stollarz / Staff via Getty Images
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    ‘An incredible undertaking’: 5 takeaways from Philips consent decree

    Under the agreement, the FDA will use rare powers to require repairs, replacements or refunds for recalled respiratory machines.

    By Updated April 17, 2024
  • Abbott company sign outside
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    Courtesy of Abbott Laboratories

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    Abbott looks to ‘highly productive’ device pipeline for future growth

    CEO Robert Ford highlighted new and upcoming products throughout the earnings call, calling the recently approved Triclip valve a “billion-dollar opportunity."

    By April 17, 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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    FDA warns Soulaire to stop selling device outside authorized uses

    Soulaire marketed its external counterpulsation system to grow new arteries, repair organ dysfunction and treat COVID-19, among other uses, without evidence.

    By April 17, 2024
  • Professional photo of Jan Makela
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    Permission granted by GE HealthCare
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    GE Healthcare imaging CEO to resign

    Jan Makela plans to leave the company in July to join another firm.

    By April 16, 2024
  • Johnson & Johnson's new logo is seen on an office lobby wall.
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    Courtesy of Johnson & Johnson
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    ‘We think in decades’: J&J’s $30B spending spree may not be over

    After Johnson & Johnson has doled out more than $30 billion for Abiomed, Laminar and Shockwave Medical, are more medtech deals on the way?

    By April 16, 2024
  • Professional photo of Shirley Edwards
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    Courtesy of Solventum
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    Solventum appoints Shirley Edwards to board of directors

    The 3M spinoff highlighted Edwards’ expertise in mergers and acquisitions and corporate governance as an asset.

    By April 16, 2024
  • Abbott HeartMate 3 left ventricular assist device
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    Courtesy of Abbott
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    Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths

    Biological material can build up and obstruct blood flow in heart failure patients supported by the left ventricular assist devices, the FDA said.

    By April 15, 2024
  • A corporate building for Edwards Lifesciences.
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    Courtesy of Edwards Lifesciences
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    Edwards pushes back on Medtronic’s head-to-head TAVR trial

    Edwards Lifesciences and Wall Street analysts questioned the results of Medtronic’s women-focused study, claiming the data are inconsistent with real-world evidence.

    By April 15, 2024
  • Exact Sciences precision oncology lab
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    Courtesy of Exact Sciences
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    Exact Sciences names Aaron Bloomer CFO

    The executive will succeed Jeff Elliott, who said in January he would step down due to personal reasons.

    By April 15, 2024
  • 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
  • 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
  • dna tube
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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