Medical Devices

  • A person wearing gloves hangs a clear bag with fluid on a metal hook.
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    Bevan Goldswain via Getty Images
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    Tariffs send healthcare industry into ‘unchartered waters’

    Provider groups and health systems warn tariffs will test healthcare’s fragile supply chain, and Wall Street said medtech businesses will face pressure, particularly diabetes tech firms.

    By Susanna Vogel , • April 4, 2025
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    VCG via Getty Images
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    China readies 34% tariff on US imports starting April 10

    The country’s retaliation against President Donald Trump’s trade policies builds upon previously announced duties.

    By Max Garland • April 4, 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
  • A close up of the Eargo 6 hearing device.
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    Permission granted by Eargo
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    Eargo, Hearx merge into one OTC hearing aid firm, receive $100M boost

    Hearx, the maker of Lexie hearing aids, and Eargo competed for the OTC hearing aid market created by the FDA in 2022.

    By • April 3, 2025
  • Dr. Mehmet Oz arrives for his confirmation hearing with the Senate Finance Committee in the Dirksen Senate Office Building on March 14, 2025 in Washington, D.C.
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    Anna Moneymaker / Staff via Getty Images
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    Dr. Oz confirmed to lead CMS

    Dr. Mehmet Oz, a physician and TV personality, will lead the agency during a turbulent time for federal health programs as the HHS lays off thousands of staffers and Republicans float potential cuts to Medicaid.

    By Emily Olsen • Updated 11 hours ago
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    Justin Sullivan via Getty Images
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    Trump tariffs

    AdvaMed repeats call for tariff exemption as new levies threaten healthcare supply chain

    Lobby groups like AdvaMed and the American Hospital Association have so far failed to get medical devices and critical supplies carved out from the Trump administration’s tariffs.

    By , Susanna Vogel • April 3, 2025
  • A picture of a doctor looking at an X-ray screen during a procedure.
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    Permission granted by Boston Scientific
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    Boston Scientific’s Farapulse matches Medtronic cryoablation in trial

    Atrial tachyarrhythmia recurred in 39 patients treated with Boston Scientific’s Farapulse PFA device, while 53 people had recurrence in the Medtronic cryoablation group.

    By • April 3, 2025
  • President Donald Trump waves to a crowd at the White House on April 2, 2025.
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    Andrew Harnik via Getty Images
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    Trump tariffs

    Trump installs 10% baseline tariff, country-specific duties

    The president said he will levy import taxes on China, Japan and others equal to half of what they charge the U.S. based on White House calculations.

    By Philip Neuffer • April 3, 2025
  • A procedure is performed in an operating room using CMR Surgical's Versius robotic system.
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    Courtesy of CMR Surgical
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    CMR Surgical secures $200M for US robot rollout

    Launching Versius in the U.S. is a top priority for CMR, which claims the system is the second most adopted soft tissue robot globally.

    By • April 2, 2025
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    Kevin Dietsch via Getty Images
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    HHS overhaul

    ‘Just goodbyes and crying’: CDRH hit in HHS mass layoffs

    Teams working on communications and policy were cut from the agency on Tuesday, according to multiple FDA workers interviewed by MedTech Dive.

    By • April 2, 2025
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    Jolygon via Getty Images
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    3 takeaways from ACC 2025

    Medtronic, Abbott and Boston Scientific had updates on their devices used in heart valve disease treatment at the event.

    By • April 2, 2025
  • A picture of a researcher standing in front of a testing machine in a laboratory.
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    Karen Ducey/Getty Images via Getty Images
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    Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

    The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

    By • April 1, 2025
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    Alexander Ford via Getty Images
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    Bausch + Lomb recalls Envista intraocular lenses over safety risks

    J.P. Morgan analysts said it was too early to discuss the financial impact of the recall, but estimated that $70 million to $90 million of revenue could be at risk this year.

    By • March 31, 2025
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    Permission granted by Tandem Diabetes Care
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    Tandem eyes Medicare coverage expansion for Type 2

    CMO Jordan Pinsker said Tandem hopes to expand Medicare coverage of its automated insulin delivery systems using new data shared at ATTD.

    By • March 31, 2025
  • Two medical device generator towers with computer screens on top against a white background.
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    Courtesy of Johnson & Johnson
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    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
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    Anna Moneymaker via Getty Images
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    HHS overhaul

    ‘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 announced Thursday, sources said.

    By Sydney Halleman , Ned Pagliarulo , Rebecca Pifer • March 28, 2025
  • A picture of a medical catheter against a white background.
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    Courtesy of Abbott
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    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
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    Courtesy of Beta Bionics
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    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
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    Courtesy of Dexcom
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    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.
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    Kevin Dietsch/Getty Images via Getty Images
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    HHS overhaul

    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.
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    Peter Morgan/AP

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    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.
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    Anna Moneymaker/Getty Images via Getty Images
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    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
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    Courtesy of Dexcom
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    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
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    Permission granted by Dexcom
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    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
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    Courtesy of Beacon Biosignals
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    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
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    Courtesy of Abbott Laboratories

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    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