Diagnostics: Page 16


  • Carl Icahn with a beard in 2015
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    Neilson Barnard via Getty Images
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    Illumina-Icahn proxy battle heats up as Grail divestment orders loom

    DNA-sequencing provider Illumina is headed for a showdown with billionaire financier Carl Icahn over three of nine seats on its board of directors as it continues to defy regulators’ orders to divest cancer test maker Grail.

    By April 12, 2023
  • Blood cancer
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    Getty Images
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    Function Oncology raises $28M to use CRISPR to tailor cancer diagnosis and treatment

    The startup says its genomics platform can improve on conventional sequencing by uncovering drug target vulnerabilities directly in patient tumor samples.

    By April 12, 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
  • Close up of Carl Icahn
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    Michael Nagle via Getty Images
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    Icahn pushes for spinoff of Illumina’s Grail liquid biopsy unit

    The billionaire financier, who is waging a proxy fight for seats on Illumina’s board, is arguing that Grail should become a standalone publicly traded company.

    By April 11, 2023
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    Getty Images
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    Medtech buyouts by private equity in Q4 shed light on deal-making trends in 2023: report

    Medtech companies are continuing to spin off assets to realign portfolios, creating opportunities for private equity firms to buy businesses and exit existing investments.

    By April 11, 2023
  • An Illumina genetic sequencing device
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    Courtesy of Illumina
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    Illumina backs its board in proxy fight with Icahn

    Illumina directors up for re-election to one-year terms include prominent leaders in healthcare such as former FDA Commissioner Scott Gottlieb and longtime Intuitive Surgical CEO Gary Guthart.

    By April 10, 2023
  • A person stands near an open MRI machine.
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    Permission granted by Fujifilm
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    Q&A

    Friday Q&A: Fujifilm’s Henry Izawa on navigating a tough hospital equipment market

    The CEO of Fujifilm Healthcare Americas discusses integrating Hitachi’s diagnostic imaging business, new product launches and how hospital budgets are changing the market for imaging.

    By April 7, 2023
  • Carl Icahn head shot
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    Mat Szwajikos via Getty Images
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    Icahn ramps up rhetoric on Illumina after FTC orders Grail sale

    In a letter to Illumina shareholders, Icahn says the two companies “should be separated immediately” to protect “long term growth prospects.”

    By Peter Green • April 5, 2023
  • The entrance signage for the United States Department of Justice Building.
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    Getty Images
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    Diagnostics execs charged with concealing lead test flaw

    The former CEO and two other top executives of Magellan Diagnostics are accused of hiding a malfunction that caused tens of thousands of children and adults to receive inaccurately low lead test results.

    By Updated April 5, 2023
  • Close up of Diana DeGette standing outside
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    Anna Moneymaker via Getty Images
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    Diagnostic testing reform bill has a path to the finish line this year: AdvaMed

    Legislators recently reintroduced the VALID Act, which would bring lab-developed tests and in-vitro diagnostics under one framework, after failing to pass the bill twice last year.

    By Updated April 5, 2023
  • Carl Icahn with a beard in 2015
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    Neilson Barnard via Getty Images
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    Why won’t Illumina sell Grail?

    While financier Carl Icahn and regulators in the U.S. and Europe want DNA-sequencing company Illumina to divest liquid biopsy company Grail, Illumina’s board won’t budge. Analysts say they may be waiting for the best moment.

    By April 4, 2023
  • a woman using the opioid safety device built by Masimo
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    Courtesy of Masimo
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    Masimo receives De Novo nod from FDA for device designed to detect signs of opioid overdose

    The system detects patterns associated with opioid-induced respiratory depression and sends alerts that escalate in line with the risk level.

    By April 4, 2023
  • A person wearing safety goggles holds a pipette of fluid.
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    Courtesy of Grail
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    Illumina ordered to divest Grail by FTC on anticompetition concerns

    The San Diego-based DNA-sequencing company, which also faces a challenge from European antitrust regulators, said it will appeal the FTC’s order.

    By April 3, 2023
  • Carl Icahn with a beard in 2015
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    Neilson Barnard via Getty Images
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    Illumina urges shareholders to reject Icahn board nominees

    The DNA-sequencing company says Icahn’s board nominees don’t understand its business or the regulatory process.

    By March 31, 2023
  • a lab worker
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    Courtesy of Elypta
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    Potential to improve early cancer detection lands Elypta prize inspired by Star Trek creator

    The metabolism-based liquid biopsy improved on the ability of genomic tests to detect stage I cancers in a recent study.

    By March 30, 2023
  • Breast cancer cells
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    Ewa Krawczyk, National Cancer Institute

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    Breast cancer AI company iCAD lays off workers, names new CEO

    The company, which reported a net loss on Tuesday, is also exploring strategic alternatives for its Xoft therapy business.

    By March 29, 2023
  • Thierry Bernard, Qiagen CEO in a headshot, with short grey hair and glasses
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    Courtesy of Qiagen
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    Qiagen’s Thierry Bernard named chair of the AdvaMedDx board

    Thierry Bernard, the CEO of Qiagen, succeeds Norman Schwartz, CEO of Bio-Rad Laboratories, in leading the diagnostics division of trade association AdvaMed.

    By March 28, 2023
  • An artists rendering of a human body showing the heart in red and a pacemaker device with antennae
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    Courtesy of Antennaware
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    AntennaWare secures patent for wireless tech designed to unlock implant applications

    AntennaWare sees the technology facilitating deep-tissue implants that unlock new ways to monitor and treat disease.

    By March 27, 2023
  • Carl Icahn head shot
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    Mat Szwajikos via Getty Images
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    Icahn says Illumina directors got personal insurance after Grail deal

    The extra liability coverage shows the directors feared unspecified consequences from closing the acquisition of Grail, according to the activist investor.

    By Updated March 24, 2023
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    Courtesy of Roche
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    Roche, Lilly team on test for early detection of Alzheimer’s

    The tool is intended to help gauge whether patients should receive further evaluation to confirm a diagnosis.

    By Updated March 22, 2023
  • A person wearing safety goggles holds a pipette of fluid.
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    Courtesy of Grail
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    Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail

    The DNA-sequencing company said the activist investor hasn’t offered any better solutions for satisfying regulators’ concerns about the acquisition.

    By March 20, 2023
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    FDA sets end date for raft of COVID-related shortages that began early in pandemic

    Shortages of home-use ventilators and clinical sample concentrators are expected to continue.

    By March 20, 2023
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    Getty Images
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    Medtech trade group pushes UK to support ambitious Software as a Medical Device program

    Reams of data collected by the National Health Service, paired with advanced work in artificial intelligence at U.K. universities, could make Britain a digital health leader if the government acts. 

    By March 15, 2023
  • Sofia® 2 SARS Antigen+ FIA
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    Courtesy of QuidelOrtho
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    QuidelOrtho COVID test is first to win FDA nod via premarket review

    Special controls instituted by the FDA as part of the De Novo assessment pave the way for other tests to come to market without pandemic-era Emergency Use Authorization.

    By March 9, 2023
  • Abbott gets FDA nod on lab blood test for concussion

    Results are available in about 18 minutes and can rule out the need for a CT scan if negative, the company said.

    By March 8, 2023
  • iRhythm Zio XT
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    Permission granted by iRhythm Technologies
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    iRhythm, fighting Boston Scientific for market share, shows cardiac monitor beats rivals

    An analysis of Medicare claims data found iRhythm Technologies’ Zio XT outperforms other ambulatory cardiac monitors.

    By March 8, 2023