Diagnostics: Page 10

  • Thaysen is pictured in a suit and tie.
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    Permission granted by Illumina
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    Illumina cut 12% of global staff over past year: CEO

    The genomics company, which initiated a fresh round of layoffs last month, expects to finalize its Grail divestiture by the end of June, Jacob Thaysen said Thursday.

    By • Feb. 9, 2024
  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina to lay off 111 people at San Diego headquarters

    The job cuts, expected by March 12, include senior management positions, scientists and engineers.

    By • Feb. 8, 2024
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline➔
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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
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    Invitae hires advisers, considers bankruptcy: WSJ

    Sources told the Wall Street Journal a bankruptcy filing could come within weeks.

    By • Feb. 7, 2024
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    Hologic wins FDA clearance for AI-enabled cervical cancer screening system

    The product creates digital images of Pap test slides and uses an AI algorithm to identify cells for review.

    By • Feb. 5, 2024
  • Laboratory research, dropping liquid to test tubes, Blue tone
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    Permission granted by Veeva Systems
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    FDA to reclassify most high-risk IVDs, easing path to clearance

    The effort comes ahead of the regulator’s plan to finalize a rule that would expand its oversight of laboratory-developed tests.

    By • Feb. 5, 2024
  • FDA Commissioner Robert Califf speaks during the COVID Federal Response Hearing on Capitol Hill on June 16, 2022.
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    Califf backs increased LDT oversight despite industry opposition

    At a Wednesday event, the FDA commissioner named the laboratory-developed test proposal as a top priority and addressed questions on AI.

    By • Feb. 1, 2024
  • With the digital cervical cytology system, the samples can be scanned, converted to a digital slide image, and then reviewed on a computer monitor in a lab or from a remote location.
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    Courtesy of BD
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    BD partners with Techcyte to offer AI-enhanced cervical cancer screening

    Techcyte has developed a system to reduce the amount of cells pathologists need to review.

    By • Feb. 1, 2024
  • A sign announces the company name at Agilent's headquarters building in Santa Clara, California.
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    Agilent, Incyte to partner on companion diagnostics

    The collaboration comes after Agilent restructured and sold its liquid biopsy unit. 

    By • Jan. 30, 2024
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott says all four segments stronger than pre-pandemic

    CEO Robert Ford said investing in its base business using COVID-19 testing revenues was “absolutely the right strategy.”

    By • Jan. 24, 2024
  • European Union flags are pictured waving outside the European Commission building.
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    Carl Court via Getty Images
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    European Commission proposes delays for IVDR to prevent supply disruption

    Officials are planning to give manufacturers another 31 months to get tests certified under the In Vitro Diagnostic Medical Devices Regulation.

    By • Jan. 24, 2024
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    Invitae sells reproductive health assets amid liquidity concerns

    DNA testing firm Natera could pay up to $52.5 million total, and plans to move Invitae’s customers to its own tests.

    By • Jan. 22, 2024
  • Signs for Johnson & Johnson are seen on company offices in California.
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    Mario Tama via Getty Images
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    3 bellwether companies to watch as medtech earnings season begins

    J&J, Intuitive Surgical and Abbott kick off this week with fourth-quarter reports.

    By • Jan. 22, 2024
  • Close up of a droplet being dropped into a test tube
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    FDA, CMS defend plans to increase oversight of laboratory developed tests

    In a joint letter Thursday, leaders from the agencies outlined why they are opposed to using the Clinical Laboratory Improvement Amendments to address concerns with LDTs.

    By • Jan. 19, 2024
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA authorizes record number of new devices in 2023

    The FDA shared the figures in the CDRH’s annual report, which also features updates on its work on MDUFA V goals.

    By • Jan. 18, 2024
  • Dermasensor's real-time, non-invasive skin cancer evaluation system.
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    Courtesy of Dermasensor
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    Dermasensor wins FDA clearance for AI-enabled skin cancer detection device

    A study found the sensitivity of the device was 96%, compared with 83% for primary care physicians.

    By • Updated Jan. 22, 2024
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    Imvaria and Darmiyan receive FDA authorizations for AI-enabled diagnostic tools

    The de novo classifications cover software for detecting a lung condition and assessing dementia risk.

    By • Jan. 17, 2024
  • UK Parliament
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    Retrieved from Wikimedia Commons on December 15, 2021
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    UK shares roadmap for creation of new medtech regulatory framework

    The MHRA plans to have the “core elements” of the new framework for medical devices in place by the next year.

    By • Jan. 12, 2024
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    Courtesy of Boston Scientific
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    Deep Dive

    5 medtech trends to watch in 2024

    From the M&A outlook and tough year-over-year comparisons to emerging markets like pulsed field ablation, here are the top medical technology trends to watch this year.

    By • Jan. 9, 2024
  • A physician holds a box containing Delfi's FirstLook Lung cancer blood test.
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    Susan Tousi leaves Illumina to become CEO of liquid biopsy firm Delfi

    Tousi is in charge of commercializing the lead liquid biopsy from a company that could compete with Grail, the multi-cancer early detection test maker Illumina plans to divest.

    By • Jan. 9, 2024
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    Thermo Fisher Scientific
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    Thermo Fisher to lay off 74 California workers in restructuring

    The scientific instruments maker, which has been streamlining operations to cut costs, said the latest job reductions would be effective Feb. 1.

    By • Jan. 5, 2024
  • A droplet from a pipette hangs over a series of test tubes in this stock image.
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    Getty Images
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    Medicare spending on lab tests fell 10% in 2022, OIG finds

    The decline was driven by lower volumes across most types of tests, including genetic and COVID-19 tests.

    By • Jan. 4, 2024
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Roche to buy LumiraDx’s point-of-care technology for $295M

    LumiraDx faces financial pressures amid declining test sales and a potential delisting from the Nasdaq.

    By • Jan. 2, 2024
  • A person wearing safety goggles holds a pipette of fluid.
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    Courtesy of Grail
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    Roundup: Illumina’s long goodbye to cancer test maker Grail

    From the start, the DNA sequencing leader faced pressure to unwind its $8 billion acquisition of the cancer screening developer. As 2023 drew to a close, it has finally agreed.

    By • Dec. 21, 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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    Sarah Silbiger via Getty Images
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    FDA approves first DNA test for risk of opioid use disorder

    The approval comes a little over one year after an FDA advisory committee overwhelmingly voted against an earlier version of the test.

    By • Dec. 20, 2023
  • A head shot of Grail CEO Bob Ragusa
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    Grail CEO predicts ‘transformative’ 2024 amid Illumina split

    The liquid biopsy maker, which Illumina plans to divest, said it has made progress on a PMA application with the FDA for its Galleri multi-cancer early detection test.

    By • Dec. 19, 2023