Medical Devices

  • Two medical device generator towers with computer screens on top against a white background.
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    Image attribution tooltip

    J&J launches energy generator compatible with Ottava robot

    Johnson & Johnson said the Dualto energy system’s design allows for up to 46% less footprint than separate generators.

    By • March 28, 2025
  • RFK Jr. strides down a Capitol Hill hallway thronged by aides and reporters.
    Image attribution tooltip
    Anna Moneymaker via Getty Images
    Image attribution tooltip

    ‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs

    Many HHS department heads and employees were unaware of plans to fire some 10,000 employees until they were publicly announced Thursday, sources said.

    By Sydney Halleman , Ned Pagliarulo , Rebecca Pifer • March 28, 2025
  • Close up of hand touching smartwatch with health app on the screen. Explore the Trendline➔
    Image attribution tooltip
    Sitthiphong via Getty Images
    Image attribution tooltip
    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
  • A picture of a medical catheter against a white background.
    Image attribution tooltip
    Courtesy of Abbott
    Image attribution tooltip

    Abbott snags early CE mark for Volt PFA device

    With PFA becoming physicians’ preferred ablation method for treating AFib, Abbott is pushing to catch up with rival systems already on the market.

    By • March 28, 2025
  • A black, square device with tubing connected to a patch is next to a phone that says "Beta Bionics" and another patch that says DexcomG6
    Image attribution tooltip
    Courtesy of Beta Bionics
    Image attribution tooltip

    Newly public Beta Bionics reports sales surge; Dexcom hires CCO

    Sales of Beta Bionics insulin pumps spiked 145% in the fourth quarter behind solid new patient starts. Elsewhere, former Masimo exec Jon Coleman joined Dexcom, and Sibionics’ CGM earned the CE mark.

    By • March 28, 2025
  • The Dexcom G7 Continuous Glucose Monitoring (CGM) System
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    Dexcom rejects claims of unauthorized device changes in FDA warning letter

    A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its glucose sensors.

    By • March 27, 2025
  • Robert F. Kennedy Jr., U.S. President Donald Trump’s nominee for Secretary of Health and Human Services departs after testifying in a confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions at the Dirksen Senate Office Building on January 30, 2025 in Washington, D.C.
    Image attribution tooltip
    Kevin Dietsch/Getty Images via Getty Images
    Image attribution tooltip

    HHS to cut 10,000 employees in major restructuring under RFK Jr.

    Advamed CEO Scott Whitaker said Thursday that “any reduction in force should be accompanied by policy and regulatory improvements that encourage innovation in medtech.”

    By Ned Pagliarulo , Rebecca Pifer , • Updated March 27, 2025
  • A large green sign with Solventum written on it hangs in front of the pillars of the New York stock exchange building.
    Image attribution tooltip

    Peter Morgan/AP

    Image attribution tooltip

    Solventum cuts 800 positions

    CEO Bryan Hanson told investors last week that the restructuring plan would save Solventum $120 million annually.

    By • March 26, 2025
  • A picture of Mehemet Oz sitting behind a table in a Senate hearing room.
    Image attribution tooltip
    Anna Moneymaker/Getty Images via Getty Images
    Image attribution tooltip

    Senate committee advances Dr. Oz to lead CMS

    Democrats on the Senate Finance Committee criticized the physician and TV personality ahead of the vote Tuesday for avoiding questions about potential cuts to Medicaid.

    By Emily Olsen • March 26, 2025
  • The Dexcom G7 Continuous Glucose Monitor
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    Dexcom’s FDA warning letter reveals unauthorized changes to sensors

    Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, according to the warning letter.

    By • March 26, 2025
  • Professional photo of Jake Leach
    Image attribution tooltip
    Permission granted by Dexcom
    Image attribution tooltip
    Q&A

    Dexcom COO on 15-day glucose sensor, Type 2 coverage

    Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and an FDA warning letter.

    By • March 25, 2025
  • A headband sits on a nightstand in front of a lamp
    Image attribution tooltip
    Courtesy of Beacon Biosignals
    Image attribution tooltip
    Deep Dive

    5 tips for building a predetermined change control plan

    The new framework is intended to make postmarket changes easier for products. Experts recommend having a clear roadmap and contacting regulators early.

    By • March 25, 2025
  • Abbott company sign outside
    Image attribution tooltip

    Courtesy of Abbott Laboratories

    Image attribution tooltip

    Abbott gets FDA nod to begin IVL trial after rivals buy up competition

    J&J acquired the IVL device maker Shockwave Medical last year for $13.1 billion, and Boston Scientific agreed to buy Bolt Medical in January for up to $664 million.

    By • March 25, 2025
  • 23andMe
    Image attribution tooltip
    Justin Sullivan via Getty Images
    Image attribution tooltip

    23andMe files for bankruptcy; CEO Anne Wojcicki resigns

    The DNA-testing company plans to sell its assets after the board rejected an acquisition proposal from Wojcicki.

    By • March 24, 2025
  • HCA Healthcare's Dr. Thomas Payne wears a gray suit jacket and blue and burgundy striped bow tie, against a gray background.
    Image attribution tooltip
    Permission granted by HCA Healthcare
    Image attribution tooltip
    Q&A

    Why HCA is ‘all in’ on surgical robotics

    Thomas Payne, HCA Healthcare’s national medical director of robotics, explains how the largest U.S. health system is vetting a new crop of market entrants.

    By • March 24, 2025
  • 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)
    Image attribution tooltip
    Kevin Dietsch via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Retrieved from ICU Medical on March 21, 2025
    Image attribution tooltip

    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
  • FDA headquarters sign
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Hector Vivas via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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.
    Image attribution tooltip
    Permission granted by Monogram Technologies
    Image attribution tooltip

    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
    Image attribution tooltip
    Retrieved from Insulet on March 18, 2025
    Image attribution tooltip

    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.
    Image attribution tooltip

    Courtesy of Nucor Steel Tuscaloosa.

    Image attribution tooltip

    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.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Retrieved from Spectral AI on March 18, 2025
    Image attribution tooltip

    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