Diagnostics

  • A patient and clinician in front of a Hologic breast imaging device
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    Courtesy of Hologic
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    Hologic to go private for up to $18.3B

    Funds managed by Blackstone and TPG plan to acquire the medtech firm for up to $79 per share.

    By • Oct. 21, 2025
  • President Donald Trump speaks to reporters at the White House on Aug. 25, 2025, in Washington, D.C.
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    Chip Somodevilla via Getty Images
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    AdvaMed calls for series of trade actions in response to Section 232 probe

    In comments submitted to the Trump administration on its medical equipment investigation, the industry group recommended a tariff-free trading bloc with trusted countries among its proposals.

    By • Oct. 20, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Permission granted by Boston Scientific
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
  • BD CFO Chris DelOrefice wears a suit and tie in a headshot.
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    Courtesy of BD
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    BD CFO Chris DelOrefice leaving for new job

    Along with DelOrefice’s departure, BD reported preliminary fiscal fourth-quarter revenue that analysts said was below Wall Street consensus expectations.

    By • Oct. 16, 2025
  • A close-up shot of a woman's hands, handling a syringe of insulin.
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    Getty Images
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    Revvity, Sanofi team on early Type 1 detection; Kihealth raises funds for diabetes test rollout

    The Sanofi partnership will support clinical validation and regulatory submissions for Revvity’s new assay. Elsewhere, Kihealth raised $5 million in seed funding to launch its early detection test.

    By • Oct. 6, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    Getty Images
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    CDRH shares regulatory guidance priorities for the coming 12 months

    Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two areas of focus for the agency.

    By • Oct. 2, 2025
  • EU flags in front of the Berlaymont building, headquarters of the European Commission in Brussels, Belgium.
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    Getty Images
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    MedTech Europe pressures EU to make regulatory changes by early 2026

    The request includes a call to postpone re-certification requirements for devices already certified under the medical technology regulations.

    By • Sept. 26, 2025
  • A lab technician runs Guardant Health's Shield blood test for colorectal cancer screening in a lab.
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    Courtesy of Business Wire
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    Quest to distribute Guardant colon cancer blood test

    Guardant Health Co-CEO AmirAli Talasaz also unveiled plans to launch the Shield test for multi-cancer detection in October.

    By • Sept. 25, 2025
  • Test tube blood
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    Getty Images
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    Multi-cancer blood tests aren’t ready for routine use, review says

    Research funded by the Agency for Healthcare Research and Quality found insufficient evidence to determine the accuracy — or possible harm — of the cancer screenings.

    By • Sept. 23, 2025
  • A female scientist works in a laboratory.
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    Getty Images
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    FDA rescinds LDT final rule

    Regulation of lab developed tests returns to its status before the agency attempted to expand its jurisdiction and industry groups sued to stop it.

    By • Sept. 19, 2025
  • A man exits the front of the U.S. Capitol at dawn.
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    Win McNamee via Getty Images
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    House committee advances Medicare coverage bill for breakthrough devices

    AdvaMed welcomed the committee’s work on the legislation but called for the inclusion of diagnostics in the bill.

    By • Sept. 18, 2025
  • The exterior of the U.S. Capitol building in Washington, D.C.
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    Jemal Countess via Getty Images
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    New bill would reform lab test payment rates

    The bipartisan legislation, introduced this week in the House and Senate, seeks to prevent more cuts to Medicare reimbursement rates for diagnostic tests.

    By • Sept. 12, 2025
  • A stack of US one hundred dollar bills is spread out on a table.
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    Alamy
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    Medtech VC funding on track to hit highest value since 2021: PitchBook

    “Larger rounds increasingly favor top-tier companies and AI-native startups, leaving other startups fighting for a smaller pool of capital,” the firm said.

    By • Sept. 2, 2025
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest forms joint venture with Corewell Health

    The diagnostics company will open a lab with Corewell Health in 2027 and manage the not-for-profit health system’s existing lab facilities.

    By • Aug. 27, 2025
  • A pink stained tissue slide has a black circle with a crosshairs pointing to a segment of tissue and a patient's name and date of birth in the corner.
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    Courtesy of Paige
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    Tempus inks $81M Paige buyout to support AI model development

    CEO Eric Lefkofsky said that buying Paige “substantially accelerates” Tempus’ effort to build the largest foundation model in oncology.

    By • Aug. 26, 2025
  • Symbolic of Sino-American relations, the flag of the United States of America and the flag of the Republic of China fly together on flag poles next to each other on a sunny, windy day.
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    Getty Images
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    US to maintain lower tariff rates on China imports for 90 more days

    China also extended its suspension of additional retaliatory duties against U.S. goods, maintaining current rates until November.

    By Max Garland • Aug. 12, 2025
  • GE HealthCare's Omni Legend PET/CT system.
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    Courtesy of GE HealthCare
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    Earnings & Tariffs

    GE HealthCare projects reduced tariff expense

    Executives also said demand for capital equipment continues to be healthy. However, investors may have expected stronger order growth.

    By • July 30, 2025
  • Deira Ward (L) and Lisa Bates (R) work at a computer near a large PCR analysis machine at a Quest Diagnostics testing lab in Indianapolis, Indiana. The lab is capable of processing up to 3700 tests pe
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    Jon Cherry via Getty Images
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    Quest, Labcorp downplay ‘Big Beautiful Bill’ impact

    Executives at the laboratory companies said they expect the effects on testing services from the Republicans’ tax and domestic policy bill, including cuts to Medicaid, will be minimal.

    By • July 29, 2025
  • A technician performing tests at Labcorp
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    Courtesy of Labcorp
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    Labcorp to buy some Community Health assets for $195M

    The deal includes outreach laboratory services in 13 states. Community Health will continue to operate its inpatient and emergency department labs along with other hospital-based testing services.

    By • July 24, 2025
  • A sign announces the company name at Agilent's headquarters building in Santa Clara, California.
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    Permission granted by Agilent
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    Agilent CFO Bob McMahon resigns

    Rodney Gonsalves, corporate controller and principal accounting officer, will take on interim CFO duties. Analysts said the company’s reaffirmed third-quarter guidance should reassure investors.

    By • July 17, 2025
  • Abbott BinaxNOW home COVID-19 test
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    Abbott

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    Earnings & Tariffs

    Abbott lowers sales forecast on diagnostics decline, US funding cuts

    Medical device sales remained a bright spot for the company, however, with more than 20% growth in diabetes devices.

    By • July 17, 2025
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest to offer Fujirebio’s FDA-cleared Alzheimer’s blood test

    The company plans to make the diagnostic available to physicians and researchers this summer, expanding its portfolio beyond laboratory developed tests.

    By • July 15, 2025
  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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    Waters, BD biosciences unit agree to $17.5B merger

    The BD business will be spun off and merged with a Waters subsidiary. Waters shares were down about 11% in early trading Monday on the news.

    By • July 14, 2025
  • A head shot of Martin Stumpe, Danaher's chief data and artificial intelligence officer.
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    Permission granted by Danaher
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    Danaher appoints Martin Stumpe as chief technology and AI officer

    The company said Stumpe’s promotion is a “pivotal step in [its] digital transformation and its ambition to lead the next era of innovation in life sciences and diagnostics.”

    By • June 30, 2025
  • EU flags in front of the Berlaymont building, headquarters of the European Commission in Brussels, Belgium.
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    Getty Images
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    MedTech Europe urges EU to exclude devices, diagnostics from trade war

    MedTech Europe said the EU’s list of products it could target in retaliation for U.S. actions “includes over 800 trade codes related to medical technologies.”

    By • June 23, 2025
  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina to buy SomaLogic for up to $425M

    Illumina said adding SomaLogic would support the company’s multiomics strategy and strengthen the value of its NovaSeq X products.

    By • June 23, 2025