Diagnostics: Page 12

  • 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.
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    Courtesy of Paige
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    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
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    Courtesy of U.S. Food and Drug Administration
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    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
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Permission granted by Boston Scientific
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    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
  • Promotional courtesy shot of a Cue Health Covid-19 test
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    Courtesy of Cue Health Press Kit
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    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
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    Courtesy of GuardantHealth
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    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.
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    Permission granted by Illumina
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    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
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    Courtesy of 23andMe
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    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.
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    Permission granted by Noah Medical
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    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
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    Getty Images
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    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.
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    Getty Images
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    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.
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    Getty Images
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    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.
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    Luke Dray / stringer via Getty Images
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    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.
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    Permission granted by Cepheid
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    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
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    Getty Images
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    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
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    Getty Images
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    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
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    freepik.com/kjpargeter

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    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
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    Courtesy of Labcorp
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    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
  • Securities and Exchange Commission, SEC, Building in Washington DC
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    Getty Images
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    Illumina faces SEC probe over Grail acquisition

    The securities regulator has asked for documents tied to the 2021 deal in addition to the conduct and compensation of members of Illumina and Grail management.

    By • Aug. 14, 2023
  • Promotional courtesy shot of a Cue Health Covid-19 test
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    Courtesy of Cue Health Press Kit
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    Cue Health wins $28M BARDA contract to develop rapid respiratory infection test

    The company plans to launch the respiratory panel for the 2024-25 virus season and aims to break even in 2025.

    By • Aug. 14, 2023
  • Medicare enrollment form and money.
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    Getty Images
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    Median lag between FDA authorization and Medicare coverage hits 6 years: study

    Fewer than 30% of novel medical devices obtain some Medicare coverage in the three years after regulatory authorization, researchers found.

    By • Aug. 11, 2023
  • Illumina NovaSeq X Series genome sequencing machine
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    Courtesy of Illumina
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    Illumina shakes up executive team, lowers 2023 outlook

    The gene sequencing industry leader, which is operating under an interim CEO, named a new chief technology officer and announced the departure of its chief medical officer.

    By • Aug. 10, 2023
  • a lab worker with testubes of blood
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    Courtesy of GuardantHealth
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    Guardant, Illumina agree to end litigation, extend commercial partnership

    The two sides will now renew a long-term collaboration to advance cancer research, Guardant said.

    By • Aug. 8, 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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    Pressure mounts for Illumina to divest Grail amid record fine, executive changes

    Illumina is facing a 432 million euro fine from European regulators and is looking for a new CEO.

    By • Aug. 8, 2023
  • Abbott company sign outside
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    Courtesy of Abbott Laboratories

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    Abbott lands FDA clearance of Alinity complete blood count system

    The company claims the device uses less floor space and has one of the highest throughputs as it competes with diagnostic systems made by Beckman Coulter and Siemens Healthineers.

    By • Aug. 8, 2023
  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
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    Getty Images
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    AI reduces radiologist workload in mammography clinical trial but expert urges caution

    The trial linked the AI-supported screen-reading procedure, ScreenPoint Medical’s Transpara, to a 44% reduction in radiologist workload.

    By • Aug. 2, 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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    Varian logistics slow growth at Siemens Healthineers in Q3

    Healthineers has worked through some logistics problems but now faces a race to install Varian equipment at customer sites. 

    By • Aug. 2, 2023