COVID-19: Page 7


  • Abbott BinaxNOW home COVID-19 test
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    Abbott

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    Procedure volatility, testing uncertainty & FDA delays: Medtech trends in 2022

    As companies manage through the omicron surge, and with the threat of potential future variants, the medical device industry is facing another challenging year.

    Feb. 4, 2022
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    CDRH targets hiring, novel approvals among 2022-2025 strategic priorities

    FDA's Center for Devices and Radiological Health, whose staff continues to struggle with an unprecedented workload since the pandemic's start, is aiming to achieve at least 90% of its annual hiring targets for certain years.

    By Feb. 4, 2022
  • BD Veritor system for rapid detection of SARS-CoV-2
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    Courtesy of BD/PRNewswire
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    BD's Q1 revenue beats Street despite COVID-19 testing decline

    In spite of the pandemic and macroeconomic challenges, CEO Tom Polen said the company has "confidence" to raise 2022 revenue guidance "while remaining appropriately prudent, given the current uncertain environment." 

    By Feb. 3, 2022
  • Thermo Fisher, Hologic plan for extended test demand in 2022

    In a year of ups and downs for COVID-19 testing, both companies are raising revenue guidance for 2022 as the need for diagnostics isn't fading.

    By Feb. 3, 2022
  • Siemens Healthineers CLINITEST rapid COVID-19 antigen test
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    Courtesy of Siemens Healthineers
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    Siemens Healthineers ups 2022 forecast after COVID-19 test boom, but sees increased competition

    CFO Jochen Schmitz told investors Thursday that as competition in the diagnostics space heats up this year, the company expects "revenues to decline sharply in the second half."

    By Feb. 3, 2022
  • Boston Scientific posts 15% gain in Q4 sales, expects 'headwinds' in 2022

    CEO Mike Mahoney told investors Wednesday that omicron and near-term macroeconomic challenges will continue to put financial pressure on the medtech in the first quarter and at least through the first half of this year.  

    By Feb. 2, 2022
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    Deep Dive

    3 key FDA topics for medtechs in 2022

    While the agency is looking to get back to normal operations this year, COVID-19 is poised to remain a top priority and, once again, thin resources for more traditional work, such as product reviews.

    By , Feb. 1, 2022
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    "ASE" by LeoTar is licensed under CC BY-SA 3.0
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    Roundup: Latest earnings show medtechs grappling with healthcare staffing shortages, supply chain

    Medical device companies ended 2021 on an "uninspiring" note, J.P. Morgan analysts said, as they brace for a slowdown in procedures driven by a surge in COVID-19 cases due to the omicron variant.

    By Jan. 31, 2022
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    Chip Somodevilla via Getty Images
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    iHealth Lab gets DoD order for additional 104M home COVID-19 tests

    The transaction brings the total number of kits the Department of Defense has ordered from iHealth Lab to more than 350 million, putting the company at the heart of the Biden administration's effort to boost testing capacity.

    By Jan. 31, 2022
  • Healthcare workers at Catholic Health's Mercy Hospital in Buffalo, New York, wage a strike.
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    Permission granted by Communication Workers of America
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    Deep Dive

    3 key labor trends for hospitals in 2022

    Hospitals are still grappling with rising turnover, widespread burnout and numerous staff calling in sick nearly two years after the pandemic began. It's unclear when it might get better — or how much worse it could get.

    By Hailey Mensik • Jan. 27, 2022
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    alvarez via Getty Images
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    Deep Dive

    4 key trends for procedure-reliant medtechs in 2022

    Medical device companies likely will face the same challenges this year that they have been dealing with since the pandemic's start, such as procedure volatility and hospital staffing shortages.

    By Jan. 27, 2022
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott Q4 revenue beats estimates on demand for COVID-19 tests; company warns of 2022 uncertainty

    Abbott provided an initial coronavirus test sales forecast of $2.5 billion, which is expected to occur early in the year and will be updated quarterly. Evercore ISI analysts said the company's "testing assumptions seem derisked."

    By Jan. 26, 2022
  • GE Healthcare's revenue hit by continued supply chain challenges

    GE CEO Larry Culp said Tuesday that ongoing supply chain disruptions were "most acute" in healthcare and will last through at least the first half of 2022, describing the persistent problem as the worst in decades.

    By Jan. 25, 2022
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    Mario Tama via Getty Images
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    J&J's device recovery slowed by omicron surge, with impact expected over next several months

    CFO Joseph Wolk said that the medtech giant expects pressure from COVID-19 and hospital staffing shortages to continue through the first half of 2022, with businesses recovering month by month.

    By Jan. 25, 2022
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    Kena Betancur via Getty Images
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    Medtech earnings season shows bumpy end to 2021 for some, bonanza for others

    Procedure-dependent companies were negatively impacted to a greater or lesser degree by the surge in omicron cases in their most recent quarters, while COVID-19 test makers benefitted from the spike in demand.

    By Jan. 24, 2022
  • A staff member from McSwain Union Elementary School District in Merced, California participates in the district's voluntary COVID-19 testing pilot.
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    Permission granted by Roy Mendiola
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    Diagnostics makers ride omicron surge in COVID-19 test demand. But for how long in 2022?

    The highly transmissible variant caused the Biden administration to announce plans to buy 1 billion rapid tests to provide free to Americans. However, when testing will ramp back down remains an open question.  

    By Jan. 20, 2022
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    Permission granted by Dexcom
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    Q&A

    Dexcom CEO on G7's global launch, COVID-19 slowing new patient adds, international growth

    Kevin Sayer spoke to MedTech Dive about the upcoming launch of the G7 CGM system, further expanding Dexcom ONE and feeling pandemic pressure in the fourth quarter.

    By Jan. 18, 2022
  • Abbott BinaxNOW home COVID-19 test
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    Abbott

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    Abbott, BD, Quidel pursue DTC strategies amid 'paradigm shift' for at-home, self-testing

    The three test makers said at last week's J.P. Morgan healthcare conference that they see opportunities for direct-to-consumer, digitally-connected testing for other diseases beyond COVID-19.

    By Jan. 18, 2022
  • President Joe Biden announces his winter COVID-19 plan as concerns grow over a new variant.
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    WhiteHouse.gov

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    Biden administration to buy 500M more rapid COVID-19 tests to give to Americans

    The announcement by President Joe Biden now brings the administration's total purchase to 1 billion test kits. Abbott Laboratories, iHealth and Roche have so far been awarded contracts for a combined 380 million tests.

    By Jan. 14, 2022
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    VCG / Stringer via Getty Images
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    Intuitive's da Vinci shipments beat Q4 expectations, COVID-19 impact to last through 2022

    The robotic surgery maker said during a J.P. Morgan healthcare conference presentation that it shipped a total of 1,347 da Vinci robots in 2021, a 44% increase from 2020.

    By Elise Reuter • Jan. 13, 2022
  • Philips ups recall provisions by $250M, impacted devices to more than 5M

    The Dutch medtech said the recall and supply chain issues are the primary reasons for missing fourth-quarter sales expectations by about $400 million. Philips' shares were down more than 15% early Wednesday.

    By Jan. 12, 2022
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    Win McNamee via Getty Images
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    Biden health officials defend COVID-19 testing policies amid diagnostics shortage

    Acting FDA Commissioner Janet Woodcock and others were under fire from senators during a Tuesday hearing for not doing enough to increase the availability of tests.   

    By Jan. 12, 2022
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA seeks feedback on draft device shortage guidance

    A new document poses a series of questions for industry on the overall design and operation of the policy, and is intended to help manufacturers provide timely information about supply disruptions during public health emergencies.

    By Jan. 12, 2022
  • Edwards seen falling short in Q4 based on early US TAVR volume data: Jefferies

    Based on partial data for October and November, the analysts expect U.S. fourth-quarter TAVR sales to grow 7%, compared to a 14% consensus estimate.

    By Jan. 11, 2022
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    Nic Antaya via Getty Images
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    Insurers will be required to cover 8 at-home COVID-19 tests per month

    After proposing the plan in December, the Biden administration on Monday detailed its plan to have insurers cover rapid tests. Health insurance lobby AHIP warned of potential "hiccups in early days" of implementation.

    By Jan. 11, 2022