Diagnostics: Page 11

  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina to part with Grail, ending battle with regulators

    Activist investor Carl Icahn, who is suing the company over its acquisition of Grail, continued to push for the removal of several board members in a letter to fellow shareholders.

    By • Dec. 18, 2023
  • An embpty bed is surrounded by monitors and hospital equipment.
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    BTIG analysts optimistic medtech will rebound in 2024 after ‘string of rough years’

    Rising interest rates, fears about the impact of GLP-1 drugs and “choppy supply-chain dynamics” dragged on the industry this year, the analysts wrote.

    By • Dec. 18, 2023
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline➔
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    Courtesy of Intuitive Surgical
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    Trendline

    Top 5 stories from MedTech Dive

    From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • An illustration of two lungs on a scientific background colored orange.
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    Freenome starts 20,000-subject study of lung cancer blood test

    The privately held company claims its test could offer an alternative to CT imaging, which exposes people to radiation.

    By • Dec. 14, 2023
  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina prepares to divest Grail with Form 10 filing

    The DNA sequencer is preparing to unwind its 2021 acquisition of the liquid biopsy test maker while still appealing orders to do so from regulators in the U.S. and Europe.

    By • Dec. 13, 2023
  • Hologic COO Essex Mitchell
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    Courtesy of Hologic, Inc.
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    Hologic promotes Essex Mitchell to COO

    Mitchell joined Hologic as vice president of sales and commercial excellence for the GYN surgical division in 2017.

    By • Dec. 11, 2023
  • Peter Arduini, GE Healthcare
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    Courtesy of GE Healthcare
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    Advamed adds medical imaging division, names new board chair

    The medtech association is bringing on staff from the Medical Imaging & Technology Alliance to lead the new division.

    By • Dec. 11, 2023
  • The BD MiniDraw Capillary Blood Collection System obtains blood samples from a fingerstick that produce lab-quality results for some of the most commonly ordered blood tests.
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    Courtesy of Becton Dickinson
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    BD receives 510(k) clearance for fingerstick blood test sample collection device

    The clearance positions BD and partner Babson Diagnostics to support blood collection from community sites such as pharmacies.

    By • Dec. 8, 2023
  • Exterior of FDA headquarters
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    Courtesy of U.S. Food and Drug Administration
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    White House sets April target for finalization of FDA rule on lab developed tests

    TD Cowen analysts said it is “unclear if and when FDA will finalize the rule as it has faced considerable opposition.”

    By • Dec. 8, 2023
  • Nick Jonas, Dexcom
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    Courtesy of Dexcom, Nick Jonas Super Bowl kit
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    Dexcom, Hologic picked to outperform in 2024: William Blair

    For the medtech industry overall, the analysts wrote that procedure volume growth is likely to normalize after declining due to the COVID-19 pandemic.

    By • Dec. 7, 2023
  • Murielle Thinard McLane, managing partner and head of Intuitive Ventures
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    Courtesy of Intuitive Ventures
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    Intuitive’s venture capital arm launches second investment fund

    The $150 million fund will back early-stage companies focused on healthcare access, digital health, and precision diagnostics and interventions.

    By • Dec. 5, 2023
  • A machine moves between several rows of test tubes.
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    Karen Ducey via Getty Images
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    Laboratory trade group, providers oppose FDA’s lab developed test proposal

    A CDRH spokesperson confirmed to MedTech Dive that a discrepancy in the submission system used for the proposed rule led to an initial overcount of public comments.

    By • Updated Dec. 7, 2023
  • A black AI processor with a brain above it
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    Getty Images
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    GE HealthCare, Hologic put AI at center of radiology pitches

    BTIG analysts said GE HealthCare believes AI can help clinicians and radiologists do their jobs better, which is important due to the “ongoing shortage of radiologists and the high rates of burn out.”

    By • Dec. 1, 2023
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    Justin Sullivan via Getty Images
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    Labcorp to lay off 239 workers in New Jersey amid biotech slump

    The job cuts are slated for the lab services company’s early development business, which has seen orders fall and cancellations increase as the biotech sector struggles.

    By • Nov. 22, 2023
  • 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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    Getty Images
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    LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

    Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of their own home.”

    By • Nov. 16, 2023
  • Detail view of the US Capitol east facade in the early morning sun.
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    Getty Images
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    Congress delays Medicare lab payment cuts for one year

    The American Clinical Laboratory Association said it remains focused on getting legislation passed that would mitigate pending Medicare payment reductions.

    By • Nov. 16, 2023
  • President Joe Biden signs a presidential memorandum that will establish the first-ever White House Initiative on Women’s Health Research.
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    Win McNamee/Getty Images via Getty Images
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    Biden initiative aims to accelerate women’s health research

    AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.

    By • Nov. 14, 2023
  • A person wearing safety goggles holds a pipette of fluid.
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    Courtesy of Grail
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    Illumina explores options for Grail, hires advisers

    The company, facing pressure from regulators to divest Grail, also formed a special committee to speed decisions on the fate of the liquid biopsy test maker.

    By • Nov. 10, 2023
  • A person holds up a swab and a test tube for a rapid antigen test kit.
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    Phil Walter via Getty Images
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    Acon receives first FDA clearance for over-the-counter COVID-19 antigen test

    The FDA is encouraging manufacturers to transition to traditional review pathways now that the acute phase of the COVID-19 crisis is over.

    By • Nov. 10, 2023
  • Persons in physician garb standing around Siemens Cios Spin Endobronchial imaging machine
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    Retrieved from Siemsens Website on July 01, 2022
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    Siemens Healthineers’ Varian rebounds; execs mum on diagnostics sale rumors

    The company's diagnostics unit continued to struggle amid layoffs and reports of a potential sale.

    By • Nov. 8, 2023
  • President Joe Biden signs a piece of paper while seated.
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    Chip Somodevilla via Getty Images
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    White House orders HHS to start collecting reports on the safety of AI in healthcare

    President Joe Biden outlined the planned program as part of an executive order on “safe, secure, and trustworthy” artificial intelligence.

    By • Nov. 1, 2023
  • Close up of a droplet being dropped into a test tube
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    Getty Images
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    FDA holds firm on 60-day comment period for lab-developed test rule

    The agency is proposing to expand its oversight of tests made by laboratories because it says risks associated with the diagnostics have increased.

    By • Nov. 1, 2023
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    Thermo Fisher Scientific
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    Thermo Fisher cuts 2023 forecast, citing volatile economic conditions

    Customer spending remains constrained overall, while economic conditions in China have weakened, CEO Marc Casper said on a Wednesday earnings call.

    By • Oct. 25, 2023
  • 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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    Icahn sues to remove Illumina board members, asks for at least $476M in damages

    The activist investor claims board members breached their duties in the acquisition of Grail.

    By • Oct. 24, 2023
  • Image of a person wearing lab goggles and pouring a liquid out of a beaker.
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    Courtesy of Abcam
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    Danaher Q3 revenue declines as demand challenges continue

    Better-than-expected respiratory testing revenue was a bright spot, but the company’s overall orders are “bouncing along” at a bottom, CEO Rainer Blair said on a Tuesday earnings call.

    By • Oct. 24, 2023
  • Close up of a testing card that says 'control' and 'sample', with a thin red line next to each.
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    Scott Olson via Getty Images
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    US trade commission explores impact of patent rules on COVID diagnostics

    The USITC report presents conflicting testimony from the medtech industry and advocacy groups about the impact of compulsory licensing.

    By • Oct. 23, 2023