Medical Devices

  • Joaquin Duato, CEO of Johnson & Johnson, testifies before the Senate Health, Education, Labor, and Pensions Committee at the Dirksen Senate Office Building on February 08, 2024 in Washington, DC. The Committee held the hearing to investigating the cost of prescription drugs. (Photo by Kevin Dietsch/Getty Images)
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    Kevin Dietsch via Getty Images
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    J&J boosts planned US manufacturing investment to $55B

    Following big announcements from Lilly and Merck, J&J is pledging $55 billion over the next four years to open new plants.

    By Jonathan Gardner • March 21, 2025
  • An image of two Smiths Medical white plastic implantable ProPort devices against a white background.
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    Retrieved from ICU Medical on March 21, 2025
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    Smiths Medical recalls port implants, warns on endotracheal tubes

    The business, acquired by ICU Medical in 2022, has been dealing with a series of recalls and quality issues over the past several years.

    By • March 21, 2025
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    Stock via Getty Images
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    FDA posts early alert after Calyxo urinary stone device tied to death

    The alert describes a problem that can lead to excessive pressure in the kidney during procedures to remove urinary stones.

    By • March 21, 2025
  • Freight trucks arrive at Pantaco Customs Complex in Mexico City with goods to be shipped to the U.S. The trucks are surrounded by piles of shipping containers.
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    Hector Vivas via Getty Images
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    Tariffs are paused for USMCA-compliant goods. How can companies qualify?

    Businesses that previously found pursuing USMCA treatment cost-prohibitive are scrambling to determine if they meet the trade deal’s requirements.

    By Philip Neuffer • March 20, 2025
  • Nick Jonas poses in front of a glowing background, wearing a small, round device on his upper arm
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    Courtesy of Dexcom
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    Dexcom shares 15-day CGM data; Tandem posts Type 2 pivotal data

    Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.

    By • March 20, 2025
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic recalls embolization devices tied to 17 injuries, 4 deaths

    Medtronic will remove one model of Pipeline Vantage devices from where they’re used and sold and will update the instructions for another model.

    By • March 19, 2025
  • Monogram Technologies' robotic surgery system is displayed against a gray background.
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    Permission granted by Monogram Technologies
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    Monogram robot wins FDA OK; Vicarious hit by supplier woes

    Monogram Technologies secured 510(k) clearance for its robotic knee replacement system, while Vicarious Surgical blamed supply chain issues for delaying its regulatory timeline.

    By • March 19, 2025
  • Professional photo of Mark Field
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    Retrieved from Insulet on March 18, 2025
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    Insulet Chief Technology Officer Mark Field leaves

    Amit Guliani, group vice president of software engineering, was named acting chief technology officer, effective immediately.

    By • March 18, 2025
  • A person wearing a black and reflective yellow protective suit, gloves, hard hat and goggles, pointing up with a U.S. flag behind them.
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    Courtesy of Nucor Steel Tuscaloosa.

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    Tariff uncertainty sparks manufacturing anxiety, especially among small firms

    Shifting foreign suppliers could become more difficult as the Trump administration continues to enact new widespread tariff policies.

    By Kate Magill • March 18, 2025
  • A sign for the FDA is displayed outside the agency's headquarters in Silver Spring, Maryland.
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    Sarah Silbiger via Getty Images
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    Top device firms report safety data late: BMJ

    BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study found.

    By • March 18, 2025
  • Two docotors in a hospital room looking at an image of a patient's burned arm.
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    Retrieved from Spectral AI on March 18, 2025
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    Spectral AI algorithms beat physicians in burn tissue assessments

    The company plans to file the results with the FDA by mid-2025 and launch the product in 2026.

    By • March 18, 2025
  • Four robots side by side with a single arm have different instruments attached to the end.
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    Courtesy of Stryker
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    4 takeaways from AAOS 2025

    Stryker unveiled its updated Mako surgical robot and orthopedic companies expect procedure volumes to remain steady despite recession fears.

    By • March 17, 2025
  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    FDA adds hemodialysis devices to shortage list amid B. Braun disruption

    The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.

    By • March 17, 2025
  • A picture of Mehemet Oz sitting behind a table in a Senate hearing room.
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    Anna Moneymaker/Getty Images via Getty Images
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    Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing

    Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical devices once they’re FDA-approved.

    By • March 14, 2025
  • Vicarious Surgical plans to seek de novo clearance for its surgical robot.
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    Permission granted by Vicarious Surgical
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    Vicarious Surgical appoints Sarah Romano as CFO

    Romano will arrive at the robotics company just as Chief Operating Officer John Mazzola is set to retire on April 1.

    By • March 14, 2025
  • Lee Zeldin attends a press conference and squints into the sun.
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    Kevin Dietsch via Getty Images
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    EPA to reconsider emissions standards for medical device sterilizers

    Last year, the EPA issued a final rule that would limit emissions of ethylene oxide, a cancer-causing gas used to sterilize medical devices.

    By • March 13, 2025
  • A flexible tube with a needle point is positioned in front of a hand holding a controller.
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    Retrieved from Screenshot: Johnson & Johnson on March 13, 2025
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    J&J’s Monarch robot wins FDA nod for AI software update

    Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.

    By • March 13, 2025
  • A 3D rendered image of a neural cell network, colored blue and set against a black background.
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    koto_feja via Getty Images
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    Vivani to spin off neurostimulation business

    The independent company will trade as Cortigent and advance brain implants to help people recover body functions such as vision and movement.

    By • March 13, 2025
  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    FDA accuses Mid-Link of copying or falsifying medical device test data

    The agency will reject all data from the Chinese service provider’s studies after Mid-Link failed to address concerns outlined in a warning letter last year, FDA officials said.

    By • March 12, 2025
  • Capstan Medical's Dan Wallace and Maggie Nixon stand in a hallway.
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    Permission granted by Capstan Medical
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    Capstan brings surgical robot to valve replacement

    Capstan Medical, a startup focused on robotic-assisted mitral and tricuspid valve replacement, recently completed its first patient implants.

    By • March 11, 2025
  • A female nurse operates a touch screen in a medical clinic.
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    Don Wu via Getty Images
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    ECRI warns insufficient AI governance threatens patient safety

    ECRI included other medtech-related threats on its list of patient safety concerns, noting that cybersecurity breaches can delay care and diagnostic errors can lead to improper treatment.

    By • March 11, 2025
  • Image shows a spinal medical device.
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    Courtesy of Orthofix
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    Orthofix’s fired execs’ lewd, ‘graphic’ texts surface in legal battle

    Orthofix didn’t originally specify the reasons behind the 2023 firing of its CEO, CFO and CLO. Now, a court case is illuminating the story behind the terminations.

    By Maura Webber Sadovi • March 10, 2025
  • Close up of a person's hands with a pulse oximeter clipped on their pointer finger.
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    FG Trade via Getty Images
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    New FDA pulse oximetry guidelines could stall under Trump

    The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts raised concerns that it might not be finalized.

    By • March 10, 2025
  • Dexcom's Stelo continuous glucose monitor.
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    Courtesy of Business Wire
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    Dexcom receives warning letter based on FDA inspections of 2 plants

    The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek clearance for new products.

    By • March 10, 2025
  • A closeup of an entryway that reads the Federal Trade Commission.
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    Stock via Getty Images
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    FTC challenges $627M private equity takeover of Surmodics

    The regulator said the buyout “would lead to a highly concentrated market for outsourced hydrophilic coatings and eliminate significant head-to-head competition.”

    By • March 7, 2025