Diagnostics

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    Courtesy of BD
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    BD strikes supply chain pact with Trump administration

    BD plans to increase U.S. production of essential medical consumables in exchange for relief from future tariffs on its products.

    By • Oct. 6, 2026
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    Courtesy of GE HealthCare
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    GE HealthCare to acquire Sofie Biosciences for $945M

    Sofie Biosciences is expected to expand GE HealthCare’s footprint in the radiopharmaceutical industry, helping manufacture and distribute time-sensitive drugs used in PET imaging.

    By • Oct. 5, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    Getty Images
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    ARPA-H awards more than $100M to biosensor development projects

    Four organizations will develop devices for tracking heart disease, inflammation and perimenopause.

    By • Oct. 5, 2026
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    iStock/ gorodenkoff

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    Sponsored by Veeva MedTech

    Thermo Fisher Scientific accelerates market access by prioritizing the right KOLs

    Thermo Fisher turned fragmented KOL data into real-time market demand. Read how.

    Oct. 5, 2026
  • 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 to prioritize guidance on AI, surgical robots next year

    The FDA outlined its A-list and B-list guidance priorities for the 2027 fiscal year.

    By • Oct. 2, 2026
  • A Freenome employee wearing a white coat and purple gloves is shown working in a laboratory.
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    Permission granted by Freenome
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    Abbott launches Freenome’s colorectal cancer screening test

    Abbott will sell Freenome’s SimpleScreen CRC test in the U.S. alongside the Cologuard Plus stool-based test it gained in the $21 billion acquisition of Exact Sciences.

    By • Sept. 30, 2026
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    izusek via Getty Images
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    Lab test providers want Medicare payment reform. Will Congress pass it?

    Facing maximum Medicare payment cuts, test providers Quest Diagnostics and Labcorp are urging lawmakers to revamp the rate-setting process, but getting a bill through Congress this year will be a challenge.

    By • Sept. 25, 2026
  • A hand in a blue glove holds a blood sample.
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    Courtesy of Grail
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    Grail multicancer detection test wins FDA advisers’ backing

    Members of the molecular and clinical genetics panel said the first-of-a-kind blood test should not be used to replace medical guideline-recommended cancer screenings.

    By • Sept. 24, 2026
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    Getty Images
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    CMS sets preliminary cuts to Medicare lab reimbursement rates

    The American Clinical Laboratory Association warned the steep annual payment cuts threaten patient access to critical lab testing services.

    By • Sept. 22, 2026
  • Close-up of a modern building with the Mayo Clinic logo in blue and white, displayed on a vertical tiled wall with part of the adjacent structure visible.
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    Alamy
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    Mayo Clinic, Thermo Fisher partner to create Precure

    The company will generate population-scale molecular data to inform development of diagnostics, therapies and other healthcare products.

    By • Sept. 21, 2026
  • An image of a GI robot.
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    Permission granted by Neptune Medical
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    Neptune Medical secures FDA nod for endoscopy robot

    The robot is intended to give physicians more control of the endoscope during a colonoscopy procedure, which can help with detection and removal of lesions.

    By • Sept. 18, 2026
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    Courtesy of Labcorp
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    Labcorp acquires MLM Medical Labs in global expansion

    Buying MLM gives Labcorp a wholly owned laboratory network that spans North America, Europe, Asia and Africa.

    By • Sept. 9, 2026
  • A healthcare professional sits in front of a computer with heart mapping technology displayed on the screen.
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    Retrieved from Elucid on September 08, 2026
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    Elucid raises $55M to commercialize cardiovascular imaging platform

    Elucid, which gained a large medtech company as an investor, plans to grow industry partnerships as it looks to expand its AI-powered imaging platform.

    By • Sept. 8, 2026
  • GE HealthCare's Photonova Spectra photon-counting CT system is shown in a room.
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    Permission granted by GE HealthCare
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    GE HealthCare secures CE mark for photon-counting CT device

    GE HealthCare is challenging Siemens Healthineers in the market for a technology that is designed to provide clearer images than traditional CT systems.

    By • Sept. 1, 2026
  • A Cleveland Diagnostics lab technician wearing a white coat and blue gloves analyzes results from an IsoPSA sample in a lab.
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    Permission granted by Cleveland Diagnostics
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    Cleveland Diagnostics hires new CFO

    Valerie Dixon arrives at Cleveland Diagnostics as the company works to commercialize its prostate cancer test in the U.S.

    By • Aug. 27, 2026
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    Getty Images
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    Guardant Health ordered to pay $245M in patent dispute

    A U.S. court ruled Guardant willfully infringed two core patents for DNA sequencing methods in a case brought by TwinStrand Biosciences and the University of Washington.

    By • Aug. 26, 2026
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    Courtesy of Qiagen
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    Qiagen names new CEO

    Jonathan Pratt will take over the role on Sept. 1. The announcement ends Qiagen’s nearly 10-month search for a new chief executive.

    By • Aug. 25, 2026
  • An illustration of beta amyloid plaques and tau in the brain
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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
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    Roche, Eli Lilly get FDA nod for new Alzheimer’s blood test

    Labcorp and Quest Diagnostics both plan to offer the test, which secured CE mark certification earlier this year.

    By • Aug. 25, 2026
  • A portrait of Guardant Health's Sam Asgarian.
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    Permission granted by Guardant Health
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    Q&A

    How Guardant aims to expand cancer screening with a blood test

    Sam Asgarian, Guardant Health’s vice president of clinical development, discusses the progress and challenges of blood-based testing in colorectal and multicancer screening.

    By • Aug. 18, 2026
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    Getty Images
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    Baylor Genetics discloses patient information exposed in cyberattack

    A third party may have accessed test results and Social Security numbers held by the genetic testing company.

    By • Aug. 18, 2026
  • J&J's Monarch robotic surgery system for bronchoscopy is shown against a gray background.
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    Permission granted by Johnson & Johnson
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    J&J’s Monarch robot wins FDA nod for AI features

    The lung bronchoscopy robot adds improvements that include new tools for pre-procedure planning and updated navigation and visual guidance during the procedure.

    By • Aug. 17, 2026
  • Scientists working in Laboratory for visual analyze the sample in petri dish.
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    Getty Images
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    Thermo Fisher closes $1.1B sale of microbiology unit to PE firm

    European private equity firm Astorg will run the business as an independent diagnostics company, led by former PerkinElmer CEO Dirk Bontridder.

    By • Aug. 13, 2026
  • A Grail employee in white coat and blue gloves works with a blood sample.
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    Courtesy of Grail
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    FDA sets advisory panel for Galleri multicancer screening test

    Outside experts will convene in September to review Grail’s premarket approval application for the MCED blood test. Experts selected for the committee will be key to watch, an analyst said.

    By • Aug. 7, 2026
  • A portrait of Danaher CEO Julie Sawyer Montgomery.
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    Permission granted by Danaher
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    Danaher promotes Julie Sawyer Montgomery to CEO

    The executive has led Danaher’s diagnostics business, where she helped triple operating profit during her tenure and oversaw the recent acquisition of Masimo.

    By • Aug. 4, 2026
  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
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    Courtesy of Siemens Healthineers
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    Siemens Healthineers names new head of the Americas

    The company disclosed the appointment of João Seabra the day before cutting its full-year sales outlook in response to continued challenges at its diagnostics division.

    By • Aug. 3, 2026