COVID-19


  • Promotional courtesy shot of a Cue Health Covid-19 test
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    Courtesy of Cue Health Press Kit
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    FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs

    Cue Health began the recall of nearly 250,000 COVID-19 test kits in May, shortly after the FDA advised people at home and healthcare professionals not to use the products.

    By Oct. 17, 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
  • Promotional courtesy shot of a Cue Health Covid-19 test
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    Courtesy of Cue Health Press Kit
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    FDA advises against using Cue Health COVID-19 tests, sends warning letter

    Agency inspectors found Cue made unauthorized changes to its COVID-19 kits that “reduced the reliability of the tests.”

    By May 14, 2024
  • Brian Blaser is smiling in a headshot with a blurred deep green background.
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    Courtesy of QuidelOrtho
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    QuidelOrtho names ex-Abbott exec Brian Blaser as CEO

    Blaser is coming out of retirement to take charge of QuidelOrtho, after the diagnostics company fired former CEO Doug Bryant in February.

    By May 3, 2024
  • 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 to cut 230 employees

    Declining COVID-19 test sales have forced Cue to eliminate hundreds of jobs in multiple rounds of layoffs over the past several years.

    By May 3, 2024
  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
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    Courtesy of Siemens Healthineers
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    Siemens Healthineers to close fast track diagnostics unit, lay off about 90 workers

    Demand for the products peaked during the COVID-19 pandemic but has fallen away since then.

    By March 19, 2024
  • 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 axes more jobs amid declining test sales

    The company cut 94 workers at the beginning of last month and another 151 people on Jan. 25.

    By Feb. 9, 2024
  • A doctor puts a pulse oximeter on a patient's finger
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    Wavebreakmedia via Getty Images
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    FDA panel recommends new standards for pulse oximeters amid bias concerns

    Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.

    By Feb. 5, 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
  • 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 holds up a swab and a test tube for a rapid antigen test kit.
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    Phil Walter via Getty Images
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    Acon receives first FDA clearance for over-the-counter COVID-19 antigen test

    The FDA is encouraging manufacturers to transition to traditional review pathways now that the acute phase of the COVID-19 crisis is over.

    By Nov. 10, 2023
  • A doctor puts a pulse oximeter on a patient's finger
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    Wavebreakmedia via Getty Images
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    25 attorneys general urge FDA to act fast to mitigate risk of racial bias in pulse oximetry

    The AGs want the FDA to “require manufacturers and vendors of pulse oximeters to include clear, comprehensible and evidence-based warning labels.”

    By Nov. 7, 2023
  • Google COVID-19 support
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    Retrieved from Google on May 28, 2020
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    Elective procedure interest still topping pre-COVID levels, survey finds

    Google searches for 20 elective surgeries in the U.S. were at 112% of pre-COVID levels in the week ended Oct. 28, according to a report from Needham analysts.

    By Nov. 3, 2023
  • Image of a person wearing lab goggles and pouring a liquid out of a beaker.
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    Courtesy of Abcam
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    Danaher Q3 revenue declines as demand challenges continue

    Better-than-expected respiratory testing revenue was a bright spot, but the company’s overall orders are “bouncing along” at a bottom, CEO Rainer Blair said on a Tuesday earnings call.

    By Oct. 24, 2023
  • Close up of a testing card that says 'control' and 'sample', with a thin red line next to each.
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    Scott Olson via Getty Images
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    US trade commission explores impact of patent rules on COVID diagnostics

    The USITC report presents conflicting testimony from the medtech industry and advocacy groups about the impact of compulsory licensing.

    By Oct. 23, 2023
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    Sarah Silbiger via Getty Images
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    FDA approves updated COVID boosters from Pfizer, Moderna

    Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

    By Delilah Alvarado • Sept. 11, 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 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
  • 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
  • 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
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient.
    Image attribution tooltip
    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    Demand for 4-in-1 test helps Danaher’s COVID sales beat internal forecast

    Danaher said it is continuing to take market share as many customers look to consolidate their point-of-care PCR testing platforms.

    By July 26, 2023
  • A search bar with the words "illness symptoms" and drop down results
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    glegorly via Getty Images
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    Interest in elective surgeries up 115% over pre-COVID levels, Google searches show: Needham

    The rise in searches correlates with an increase in the size of the market for elective procedures, Needham analysts report, signaling better times for medtech companies.

    By June 15, 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 first non-emergency authorization for COVID test, days after Goldman downgrade

    The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.

    By Peter Green • June 7, 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’s inability to find post-COVID markets for testing prompts Goldman downgrade

    The analysts warned switching to non-COVID-19 tests will mean entering a competitive market “where larger companies with financial resources have an established installed base.”

    By June 5, 2023
  • a picture of Rochelle Walensky
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    Drew Angerer/Getty Images via Getty Images
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    CDC Director Walensky to step down in June

    Rachel Walensky, who has served as director since 2001, was criticized for the federal government’s handing of the pandemic, announcing in August last year that she planned to reorganize the CDC.

    By Sydney Halleman • May 5, 2023
  • An elderly man gives himself a covid test
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    Dragan991 via Getty Images
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    Opinion

    Ending free COVID tests risks worsening the pandemic

    If Americans start paying out of pocket for COVID tests, they'll test much less — if at all, argue representatives of the Testing at Home Coalition.

    By Amy Kelbick and Eric Zimmerman • April 20, 2023