Diagnostics: Page 2

  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    FDA seeks feedback on predetermined change control plans

    The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.

    By • Aug. 26, 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 increase global laboratory capacity for mpox testing

    The World Health Organization has declared an mpox outbreak to be a public health emergency of international concern.

    By • Aug. 26, 2024
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest inks deal for University Hospitals’ outreach lab services

    The deal continues Quest’s expansion in Ohio and extends a string of acquisitions that began in May.

    By • Aug. 23, 2024
  • A picture of NowDiagnostics' syphilis blood test against a gray background.
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    Courtesy of NowDiagnostics
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    FDA OKs first at-home syphilis test

    NowDiagnostics’ over-the-counter test can return results in 15 minutes with a single drop of blood.

    By • Aug. 19, 2024
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient.
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    Routine lab tests fail to detect long COVID in 10,000-person study

    Even people with highly symptomatic long COVID may have “no clinically observable objective findings on routine laboratory testing,” according to a study published by the Annals of Internal Medicine.

    By • Aug. 16, 2024
  • A Grail employee in a white coat works in a lab.
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    Courtesy of Grail
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    Grail to shed 350 workers in restructuring

    Less than two months after splitting from Illumina, the liquid biopsy maker is refocusing resources as it pursues an FDA submission for the Galleri multi-cancer early detection test.

    By • Aug. 14, 2024
  • A person fills multiple pipettes at once in a laboratory.
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    Permission granted by C2N Diagnostics
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    Unilabs inks deal to sell C2N Alzheimer’s blood tests in Europe

    C2N Diagnostics announced the partnership after recently receiving an investment from the Japanese drugmaker Eisai, which developed the Alzheimer’s drug Leqembi with Biogen.

    By • Aug. 12, 2024
  • A view of Building 1 at Cepheid headquarters in Sunnyvale, California. Cepheid plans to consolidate manufacturing activities at its Sunnyvale headquarters.
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    The image by Coolcaesar is licensed under CC BY-SA 4.0
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    Cepheid to cut more than 600 employees in California

    A spokesperson said the diagnostics firm is consolidating its U.S.-based cartridge manufacturing activities in California.

    By • Aug. 8, 2024
  • A picture of the exterior of a Labcorp building.
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    Courtesy of Labcorp
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    Labcorp wins FDA OK for pan-solid tumor liquid biopsy

    Shakti Ramkissoon, Labcorp’s medical lead for oncology, said the test could allow laboratories and oncologists to profile solid tumors when tissue samples are limited or unavailable.

    By • Aug. 6, 2024
  • A picture of a researcher standing in front of a testing machine in a laboratory.
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    Karen Ducey/Getty Images via Getty Images
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    Experts fear patient harm from FDA’s lab developed test rule

    Decreased access to diagnostic tests, worsening patient care and practice closures are among the concerns the AMA and others have raised as the regulation takes effect.

    By • Aug. 5, 2024
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    Courtesy of 23andMe
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    23andMe board rejects CEO Wojcicki’s take-private proposal

    A special committee of the board said the proposal offers no premium to 23andMe’s stock price, and with a lack of committed financing, is “insufficient.”

    By • Aug. 2, 2024
  • Anne Wojcicki speaking event
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    Brad Barket via Getty Images
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    23andMe CEO proposes to take company private

    Anne Wojcicki, who co-founded 23andMe, would pay 40 cents per share to buy the DNA testing company, which has been trading under $1 for nearly a year.

    By • Aug. 1, 2024
  • A GE Healthcare C-arm imaging device
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    Courtesy of GE Healthcare
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    GE Healthcare faces pressure in China as hospitals delay orders

    Johnson & Johnson’s medtech business and Philips also cited China’s order slowdown for sluggish revenue growth in the second quarter.

    By • Aug. 1, 2024
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    Justin Sullivan via Getty Images
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    Labcorp expands Ultima pact to boost genomic diagnostics

    Labcorp will use Ultima Genomics’ UG 100, a machine designed to sequence the genome for $100, to assess molecular residual disease.

    By • July 31, 2024
  • Guardant's Shield blood test for colorectal cancer is pictured in a blue box against a white background.
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    Courtesy of Guardant Health
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    Guardant wins FDA approval for colon cancer blood test

    Colorectal cancer screening rates could increase if the Shield test appeals to people who have avoided colonoscopies or stool-based tests, the company said.

    By • July 29, 2024
  • tuberculosis scan
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    Spencer Platt via Getty Images
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    AI’s expert-level image analysis can be built on flawed rationales: study

    Researchers at the National Institutes of Health found that a version of ChatGPT analyzed images at an expert level but frequently reached the right answer with incorrect reasoning.

    By • July 25, 2024
  • A lab technician runs Guardant Health's Shield blood test for colorectal cancer screening in a lab.
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    Courtesy of Business Wire
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    Guardant settles allegations it violated the False Claims Act

    The settlement resolves claims that an oncologist ordered significantly more tests after Guardant hired two people the physician recommended for jobs at the company.

    By • July 23, 2024
  • A large rectangular device says Truvian with a cartridge next to it.
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    Courtesy of Truvian
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    Truvian raises $74M to bring blood test instrument to market

    The device is designed to perform the most commonly ordered blood tests, avoiding the need to send the samples to central labs.

    By • July 22, 2024
  • Medtronic's Stacey Churchwell is pictured wearing a blue suit jacket and white shirt.
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    Permission granted by Medtronic
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    Q&A

    ‘Our next frontier is prediction’: Medtronic on AI and heart disease

    Stacey Churchwell, who leads the company’s cardiovascular diagnostics and services business, says artificial intelligence is reducing false positives in its insertable cardiac monitors, saving clinicians valuable time.

    By • July 22, 2024
  • Close up of a droplet being dropped into a test tube
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    deliormanli via Getty Images
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    Danaher setting up labs to support companion diagnostic development

    Danaher plans to open a U.K. laboratory this month, followed by a second facility in the U.S. later this year.

    By • July 18, 2024
  • A picture of an Abbott testing building.
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    Ryan David Brown/Getty Images via Getty Images
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    Deep Dive

    Medtech firms have cut more than 14,000 jobs in the past 18 months

    Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.

    By , , • Updated July 25, 2024
  • Qiagen's NeuMoDx 96 PCR sequencing machine
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    Courtesy of Qiagen
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    Qiagen to cut 175 employees, close Michigan PCR test plant

    The layoffs and plant closure are part of a restructuring plan that Qiagen estimates will cost about $400 million.

    By • July 17, 2024
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest closing Pennsylvania lab, laying off 121 people

    Quest is consolidating drug testing at a facility in Kansas, but will keep rapid response, pathology and IT staff at the Norristown site.

    By • July 17, 2024
  • Intuitive Surgical's da Vinci 5 robotic system.
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    Courtesy of Intuitive Surgical
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    J&J, Abbott and Intuitive start medtech earnings season

    The companies’ financial results will offer a glimpse at the current health of medtech markets.

    By • July 16, 2024
  • The exterior of the U.S. Capitol building in Washington, D.C.
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    Jemal Countess via Getty Images
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    House committee tells FDA to suspend lab developed test rule

    Lawmakers said the final rule carries “the risk of greatly altering the United States’ laboratory testing infrastructure.”

    By • July 15, 2024