Diagnostics: Page 11

  • A patient and clinician in front of a Hologic breast imaging device
    Image attribution tooltip
    Courtesy of Hologic
    Image attribution tooltip

    Hologic allies with Bayer to support uptake of contrast-enhanced mammography

    The companies will provide a product package and training intended to support adoption of the imaging technique.

    By • Sept. 22, 2023
  • M&A
    Image attribution tooltip
    Nuthawut Somsuk via Getty Images
    Image attribution tooltip

    Is bigger better? McKinsey predicts the return of large medtech mergers

    The analysts argue that pressure to improve margins and become the partner of choice to hospitals favors large deals.

    By • Sept. 22, 2023
  • the FDA Headquarters Explore the Trendline➔
    Image attribution tooltip
    Sara Silbiger via Getty Images
    Image attribution tooltip
    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • U.S. Government Accountability Office
    Image attribution tooltip
    "Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
    Image attribution tooltip

    Limited resources constrain federal oversight of medical device ads, GAO finds

    U.S. agencies took 322 enforcement actions related to medtech advertising between 2018 and 2022.

    By • Sept. 21, 2023
  • U.S. Capitol In Washington
    Image attribution tooltip
    Stefan Zaklin via Getty Images
    Image attribution tooltip

    CMS leader defends breakthrough device reimbursement proposal at House hearing

    Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies pathway to five reviews a year.

    By • Sept. 20, 2023
  • The European Union flag.
    Image attribution tooltip
    artJazz via Getty Images
    Image attribution tooltip

    MedTech Europe says MDR, IVDR framework needs ‘structural reform’

    Patients may face delayed access to treatments unless changes are made to the new regulatory system, 35 European trade groups warned in an open letter.

    By • Sept. 18, 2023
  • the FDA Headquarters
    Image attribution tooltip
    Sara Silbiger via Getty Images
    Image attribution tooltip

    FDA finalizes breakthrough device changes to target health inequities

    The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.

    By • Sept. 18, 2023
  • Front-facing view of an MRI machine with the words 'Signa Victor'
    Image attribution tooltip
    Courtesy of GE HealthCare
    Image attribution tooltip

    GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI

    The organizations will collaborate on the application of AI to MRI and the automation of diagnostic and interventional ultrasound.

    By • Sept. 15, 2023
  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
    Image attribution tooltip
    Thomas Andreas via Getty Images
    Image attribution tooltip

    Study suggests AI could provide second reading of mammograms

    In a separate commentary, researchers described the study as launching “the arrival of prospective trials of AI in the breast screening setting.”

    By • Sept. 12, 2023
  • Walgreens Pharmacy sign logo
    Image attribution tooltip
    Joe Raedle via Getty Images
    Image attribution tooltip

    Walgreens to pay $44M to settle claims over fraudulent Theranos tests

    If a judge approves the settlement, patients who bought a Theranos blood test would receive double the amount they paid for it. 

    By • Sept. 8, 2023
  • 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.
    Image attribution tooltip
    Courtesy of Paige
    Image attribution tooltip

    Microsoft, Paige team to use supercomputers to train cancer pathology AI models

    Microsoft will support development of a new model that is “orders-of-magnitude larger” than any in use today.

    By • Sept. 8, 2023
  • Exterior of FDA headquarters
    Image attribution tooltip
    Courtesy of U.S. Food and Drug Administration
    Image attribution tooltip

    FDA proposes 3 guidances to improve 510(k) clearance process

    The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.

    By • Sept. 7, 2023
  • Promotional courtesy shot of a Cue Health Covid-19 test
    Image attribution tooltip
    Courtesy of Cue Health Press Kit
    Image attribution tooltip

    Cue Health board pressured by investor to review strategy, cut costs

    Tarsadia Investments called for the board to “take immediate action to prevent further destruction of stockholder value.”

    By • Sept. 6, 2023
  • a lab worker with testubes of blood
    Image attribution tooltip
    Courtesy of GuardantHealth
    Image attribution tooltip

    Guardant abandons cancer blood test trial early, restates confidence in product line

    Guardant stopped enrolling new patients in the study because of its design and use of an older generation test, analysts said.

    By • Sept. 6, 2023
  • Thaysen is pictured in a suit and tie.
    Image attribution tooltip
    Permission granted by Illumina
    Image attribution tooltip

    Illumina names Agilent’s Jacob Thaysen as its next CEO

    The appointment comes less than three months after former CEO Francis deSouza stepped down following a proxy battle.

    By • Sept. 5, 2023
  • Image attribution tooltip
    Courtesy of 23andMe
    Image attribution tooltip

    23andMe wins FDA clearance to test for expanded set of BRCA cancer risk variants

    The new version of the test can report more cancer-related gene mutations, and 23andMe can add variants in the future under an agreement with the FDA. 

    By • Sept. 5, 2023
  • A photo of a robotic system used to perform lung biopsy surgery.
    Image attribution tooltip
    Permission granted by Noah Medical
    Image attribution tooltip

    Noah Medical lung biopsy robot exceeds expectations in first-in-human trial

    The startup presented early data on its FDA-cleared system at a meeting of pulmonologists in Chicago.

    By • Sept. 1, 2023
  • Image attribution tooltip
    SHansche via Getty Images
    Image attribution tooltip

    UK regulators name 3 approved bodies to ease device certification bottleneck

    A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”

    By • Aug. 31, 2023
  • Medicare enrollment form and money.
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip

    Trade groups urge CMS to expand, quickly finalize breakthrough device pathway

    The groups want changes that include expanding the program to cover breakthrough diagnostics and previously authorized products.

    By • Aug. 30, 2023
  • An illustration of two men next to briefcases, hands outstretched. One briefcase has a lightbulb, while another has stacks of cash.
    Image attribution tooltip
    DigitalVision Vectors via Getty Images
    Image attribution tooltip

    VC funding in medtech ticks up, raising hopes that slump has bottomed

    Analysts also forecast renewed interest in M&A now that large companies have worked through a string of spinoffs.

    By • Aug. 25, 2023
  • A Ugandan Red Cross worker in protective gear stands with outstretched arms at a burial site on Oct. 11, 2022.
    Image attribution tooltip
    Luke Dray / stringer via Getty Images
    Image attribution tooltip

    BARDA backs Satio’s work on patch-based Ebola test for use in remote settings

    Satio will combine its patch-based blood collection device with Institut Pasteur de Dakar's Ebola virus immunoassay.

    By • Aug. 23, 2023
  • David Persing is wearing a peach-colored button down shirt and blue blazer in a professional photo.
    Image attribution tooltip
    Permission granted by Cepheid
    Image attribution tooltip
    Opinion

    Harnessing molecular diagnostics to address antibiotic shortages

    Diagnostic testing can play an important role in public health by stopping the dangerous squandering of effective medicines that are in short supply, says David Persing, chief medical and scientific officer at Cepheid.

    By David Persing • Aug. 22, 2023
  • Prostate cancer cells, 3D illustration. Prostate cancer awareness image
    Image attribution tooltip
    Dr_Microbe via Getty Images
    Image attribution tooltip

    Agilent to wind down Resolution Bioscience liquid biopsy unit

    The company will discontinue operations at the business it bought two years ago for $550 million.

    By • Aug. 21, 2023
  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
    Image attribution tooltip
    Thomas Andreas via Getty Images
    Image attribution tooltip

    Google expands AI mammography deal with iCAD

    The amendment extends the original licensing agreement to 20 years and could allow the AI system to serve as a second reader.

    By Emily Olsen • Aug. 18, 2023
  • Free photo dna closely
    Image attribution tooltip

    freepik.com/kjpargeter

    Image attribution tooltip

    23andMe rival warns consumer test approach misses 90% of cancer variants

    The retrospective study looked at the proportion of mutations in BRCA1/2 that are covered by 23andMe’s consumer genetic test.

    By • Aug. 17, 2023
  • A technician performing tests at Labcorp
    Image attribution tooltip
    Courtesy of Labcorp
    Image attribution tooltip

    Labcorp scoops up Tufts Medicine outreach lab, continuing buying spree

    As the laboratory services giant continues its acquisition streak, hundreds of employees will be let go at the Boston-based academic health system.

    By • Aug. 15, 2023