Diagnostics

  • Two young scientists conducting medical research in a laboratory.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    CHS sells lab assets to Labcorp for $194M

    The deal, first announced in July, includes outreach laboratory services in 13 states. CHS will continue to operate inpatient and emergency department labs.

    By Susanna Vogel • Dec. 4, 2025
  • A warehouse with rows of packages
    Image attribution tooltip
    Courtesy of Medline
    Image attribution tooltip

    PitchBook: AI tuck-in deals to drive M&A acceleration in 2026

    Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.

    By • Dec. 3, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendlineâž”
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip
    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
  • A Cleveland Diagnostics lab technician wearing a white coat and blue gloves analyzes results from an IsoPSA sample in a lab.
    Image attribution tooltip
    Permission granted by Cleveland Diagnostics
    Image attribution tooltip

    Cleveland Diagnostics wins FDA nod for prostate cancer test

    The IsoPSA test is intended to help assess whether patients with elevated PSA levels should go on to receive a biopsy procedure.

    By • Dec. 2, 2025
  • Senior Research Associate Tanya Quint loads one of the instruments used to run Exact Sciences' Cologuard test at the company's headquarters in Madison, Wis. (Photo: Business Wire)
    Image attribution tooltip
    Courtesy of Business Wire/Exact Sciences
    Image attribution tooltip

    Abbott’s $21B Exact Sciences buy reveals future strategy

    The proposed deal, the biggest under CEO Robert Ford’s tenure, would allow Abbott to enter a large, new market for cancer testing. 

    By • Nov. 21, 2025
  • A sign spelling Roche hangs on the side of a building.
    Image attribution tooltip
    Sedat Suna via Getty Images
    Image attribution tooltip

    Roche inks deal for rights to Freenome cancer tests outside US

    Analysts said the deal shows Roche’s long-term strategy for its sequencing technology is “a clinical box for running NGS kits, similar to with their prior success in IVD kits.”

    By • Nov. 20, 2025
  • Modern glass and metal office building with a reflective blue-tinted facade, set against a clear blue sky. In the foreground, a large black and white sign reads “Abbott” with the company’s stylized logo and the number “645.” The area has neatly cut grass and a few small trees.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Abbott to acquire Exact Sciences for about $21B

    The purchase would give Abbott access to cancer screening tests including Cologuard and blood tests for multi-cancer early detection.

    By , • Updated Nov. 20, 2025
  • A picture of the exterior of a Labcorp building.
    Image attribution tooltip
    Courtesy of Labcorp
    Image attribution tooltip

    Labcorp inks deal to buy Parkview Health outreach laboratory assets

    The takeover extends a string of deals that have consolidated the outreach lab services market.

    By • Nov. 14, 2025
  • Sign outside Siemens building
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Siemens to reduce stake in Siemens Healthineers

    Siemens Healthineers CEO Bernd Montag said the decision is a “natural next step in our journey to becoming a fully independent company.”

    By • Nov. 13, 2025
  • The Olympus U.S. headquarters building is shown against a clear blue sky.
    Image attribution tooltip
    Retrieved from Olympus on February 03, 2025
    Image attribution tooltip

    Olympus to cut 2,000 jobs in endoscopy reorganization

    The workforce reduction is part of a restructuring designed to improve accountability and accelerate growth and innovation.

    By • Nov. 7, 2025
  • A sign notes that the U.S. Capitol Visitor Center is closed due to the government shutdown, with the capitol building in the background.
    Image attribution tooltip
    Al Drago via Getty Images
    Image attribution tooltip

    Health groups urge passage of bill to ease Medicare pay cuts for tests

    More than 30 organizations, including AdvaMed and the American Clinical Laboratory Association, are pushing for a permanent legislative solution to stop looming Medicare payment cuts for diagnostic tests.

    By • Nov. 3, 2025
  • A zoomed in picture to a person's eyes with glasses on
    Image attribution tooltip

     

    Hussey Photography, Tom Hussey

    Image attribution tooltip
    Sponsored by Danaher

    Turning aspirational innovations into tangible impacts

    Making tomorrow’s breakthroughs a reality for the patients who need.

    Nov. 3, 2025
  • A sign announces the company name at Agilent's headquarters building in Santa Clara, California.
    Image attribution tooltip
    Permission granted by Agilent
    Image attribution tooltip

    Agilent selects Adam Elinoff as CFO

    The appointment fills a position made available when Bob McMahon resigned as CFO on July 31.

    By • Oct. 31, 2025
  • Eight people line up behind a giant check.
    Image attribution tooltip
    Courtesy of MedTech Innovator
    Image attribution tooltip
    Profile

    Hemorrhage can be a serious problem after pregnancy. Here’s how one medtech founder is tackling it

    Kelsey Mayo, CEO of Armor Medical, received the grand prize in MedTech Innovator’s pitch competition for a wearable technology to detect serious blood loss early.

    By • Oct. 23, 2025
  • A patient and clinician in front of a Hologic breast imaging device
    Image attribution tooltip
    Courtesy of Hologic
    Image attribution tooltip

    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.
    Image attribution tooltip
    Chip Somodevilla via Getty Images
    Image attribution tooltip

    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
  • BD CFO Chris DelOrefice wears a suit and tie in a headshot.
    Image attribution tooltip
    Courtesy of BD
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Business Wire
    Image attribution tooltip

    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
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Win McNamee via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Jemal Countess via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    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