Diagnostics

  • The hand of a scientist in a blue glove runs a test on an Illumina sequencing machine.
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    Courtesy of Illumina
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    SEC ends probe of Illumina’s Grail acquisition

    The DNA sequencing company also cut its 2025 earnings outlook to reflect the impact of tariffs on its business.

    By • May 9, 2025
  • A container ship sits docked at the Port of Oakland on Dec. 9, 2024.
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    Justin Sullivan via Getty Images
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    Earnings & Tariffs

    Danaher predicts $350M tariff hit, moves to mitigate impact on profits

    The company is planning manufacturing footprint changes, supply chain adjustments, surcharges and cost cutting to limit the impact of the tariffs.

    By • April 24, 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
  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina, Tempus AI partner to drive genomic testing beyond cancer

    The partners plan to build evidence packages that standardize comprehensive genomic profiling and other molecular testing across all major diseases.

    By • April 18, 2025
  • A female hematologist analyzes medical samples at a hospital laboratory.
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    andresr via Getty Images
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    Deep Dive

    A judge blocked the FDA’s plan to regulate LDTs. What now?

    One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but Congress could still take on the issue.

    By • April 16, 2025
  • A view of Building 1 at Cepheid headquarters in Sunnyvale, California. Cepheid plans to consolidate manufacturing activities at its Sunnyvale headquarters.
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    The image by Coolcaesar is licensed under CC BY-SA 4.0
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    Cepheid to lay off 167 people in California

    The company laid off more than 1,300 people in California in 2023 and 2024 as respiratory sales fell from the peak hit during the pandemic.

    By • April 14, 2025
  • A computer tomography machine has two screens on the sides showing patient results.
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    Courtesy of GE Healthcare
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    Trump tariffs

    China probes US-made CT tubes after Trump hikes tariffs

    The investigation indicates that China will likely favor local medtech companies over foreign competition amid international economic tensions, a J.P. Morgan analyst said.

    By • Updated April 9, 2025
  • A picture of the exterior of a Labcorp building.
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    Courtesy of Labcorp
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    Labcorp launches blood test to accelerate Alzheimer’s diagnosis

    Manufacturers of Alzheimer’s disease drugs have identified blood tests as a way to accelerate diagnosis and treatment.

    By • April 7, 2025
  • 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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    Trump tariffs

    Tariffs send healthcare industry into ‘unchartered waters’

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

    By Susanna Vogel , • April 4, 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
  • A flat hand holds up an at-home STI test against a white bakcground
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    Courtesy of Visby Medical
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    FDA OKs first at-home test for 3 STIs

    Visby Medical’s at-home diagnostic, which can be purchased without a prescription, tests for chlamydia, gonorrhea and trichomoniasis.

    By • March 31, 2025
  • 23andMe
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    Justin Sullivan via Getty Images
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    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
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    Justin Sullivan via Getty Images
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    Labcorp to close Los Angeles site, lay off 73 people

    Labcorp lists the plant as part of its consumer genetics business and plans to begin eliminating positions in May.

    By • March 24, 2025
  • Nvidia President and CEO Jensen Huang speaks about the future of artificial intelligence and its effect on energy consumption and production at the Bipartisan Policy Center on Sept. 27, 2024 in Washington, DC.
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    Chip Somodevilla / Staff via Getty Images
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    News roundup

    Quest, Google team on gen AI; GE Healthcare plans autonomous imaging

    GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.

    By • Updated March 20, 2025
  • Two docotors in a hospital room looking at an image of a patient's burned arm.
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    Retrieved from Spectral AI on March 18, 2025
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    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
  • A technician performing tests at Labcorp
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    Courtesy of Labcorp
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    Labcorp to buy Opko unit’s cancer test assets for up to $225M

    Labcorp will acquire BioReference Health's oncology diagnostics operations as the lab company works to expand in high-growth testing areas.

    By • March 12, 2025
  • exterior of the U.S. Department of Health and Human Services
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    Alex Wong via Getty Images
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    CAP urges HHS to revoke lab developed test rule, citing Trump order

    The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for federal agencies to “alleviate unnecessary regulatory burdens.”

    By • Feb. 26, 2025
  • Thermo Fisher Scientific
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    Courtesy of Thermo Fisher Scientific
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    Thermo Fisher to buy Solventum’s purification and filtration unit for $4.1B

    Wall Street applauded the deal, sending shares of Solventum, the 3M spinoff, up 10% on Tuesday.

    By • Feb. 25, 2025
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest to buy Fresenius Medical Care kidney testing assets

    The acquisition will add dialysis-related water testing to Quest’s portfolio and position the company to perform the tests and other end-stage kidney disease services for Fresenius Medical Care.

    By • Feb. 25, 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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    Guardant accuses Natera of poaching employees, stealing trade secrets

    The lawsuit claims Natera aggressively recruited bioinformatics scientists from Guardant to “jumpstart its lagging position in the early cancer test industry.”

    By • Updated Feb. 25, 2025
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    Courtesy of GE Healthcare
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    GE Healthcare invests $138M to expand contrast media production at Ireland site

    The new facility will enable production of 25 million more patient doses per year by the end of 2027.

    By • Feb. 4, 2025
  • 23andMe
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    Justin Sullivan via Getty Images
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    23andMe considers sale as cash runs low

    The genetic testing company ended last year with $79.4 million and told investors it will need to raise money to fund its operations and financial commitments.

    By • Jan. 30, 2025
  • A picture of two people staring at the camera, one is leaning against a wall and one is sitting on a bench, in a white room.
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    Courtesy of Neko Health
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    Neko Health raises $260M to expand body scan service, fund R&D

    The company uses various medical devices to noninvasively check moles, the heart and more.

    By • Jan. 28, 2025
  • A sign that says Illumina is on a curb in front of red brick buildings.
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    Courtesy of Illumina
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    Illumina, Nvidia team to use AI in foundation models

    Nvidia’s partnership with the gene sequencing company is one of several healthcare collaborations revealed Monday by the computing giant.

    By • Jan. 13, 2025
  • Blue and yellow flags bearing the European Commission logo fly in front of a building.
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    Carl Court via Getty Images
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    EU medtech regulations reducing options for patients, companies say

    Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.”

    By • Jan. 13, 2025
  • An exterior shot of the johnson and johnson logo in red outside the company's headquarters
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    Mario Tama / Staff via Getty Images
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    Top 10 medtech deals of 2024

    Multibillion-dollar buyouts returned last year, led by Johnson & Johnson’s $13.1 billion acquisition of Shockwave Medical.

    By • Jan. 2, 2025