Diagnostics: Page 30


  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott latest to report pandemic recovery in Q2 as procedures return, COVID-19 tests drag diagnostics

    While growth was positive across the four major businesses, coronavirus test sales came in at $1.3 billion, far below the $2.2 billion reported in the previous quarter, though ahead of lowered expectations.

    By July 22, 2021
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    Win McNamee via Getty Images
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    FDA seeks funds, powers to fix ‘great weaknesses’ in medical device supply chain

    Acting FDA Commissioner Janet Woodcock wants Congress to give the agency “expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage.”

    By July 22, 2021
  • the FDA Headquarters Explore the Trendline
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    Getty / Edited by BioPharma Dive
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    PacBio inks $800M Omniome buyout to expand into short-read sequencing

    The acquisition will give Pacific Biosciences access to early-stage cancer screening and recurrence monitoring markets. The bid comes 18 months after Illumina scrapped plans to acquire PacBio amid regulatory pushback.

    By July 21, 2021
  • A building wall engraved with the words Wall Street.
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    Spencer Platt via Getty Images
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    Abbott, Intuitive and J&J kick off medtech earnings as COVID-19 bellwethers

    Intuitive and J&J are set to report results this week that will shed light on the recovery of elective procedures, while Abbott will provide insights into the drop in coronavirus test demand.

    By July 19, 2021
  • Transmission electron micrograph of a SARS-CoV-2 virus particle, isolated from a patient.
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    National Institute of Allergy and Infectious Diseases. (2020). “Novel Coronavirus SARS-CoV-2” [Image]. Retrieved from Flickr.
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    FDA grants Curative request to revoke COVID-19 test EUA, company pivots to Abbott kits after false result risk

    The agency, which announced the revocation on Thursday, originally granted an emergency use authorization to Curative’s test in April 2020. By January, FDA had concerns about false results potentially linked to sample collection.

    By July 16, 2021
  • Qiagen
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    Courtesy of Qiagen
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    Qiagen joins Abbott, Quidel cutting 2021 outlook as COVID-19 test demand wanes

    CEO Thierry Bernard blamed a faster-than-expected testing drop and uptick of vaccinations. Jefferies said the downgraded targets are disappointing, particularly given management’s forecast reiteration last month.

    By July 13, 2021
  • 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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    MDUFA talks expose ‘fundamentally different’ views of FDA and device companies

    At the latest meeting over user fees, industry remained opposed to the agency’s pitch for a Total Product Life Cycle Advisory Program, which it contends would extend the scope beyond FDA’s purview. 

    By July 12, 2021
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott lays off 400 workers amid drop in demand for COVID-19 tests

    The company cut its 2021 outlook in June, blaming a sharp, rapid decline in demand for its coronavirus-related diagnostics on global vaccination efforts. The downward trend is anticipated to continue, an Abbott spokesperson said. 

    By July 9, 2021
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    Permission granted by Quidel Corporation
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    Quidel COVID-19 PCR recall dubbed Class I by FDA due to false negative risk

    The diagnostic company said it worked with FDA to confirm “a rare potential” for false test results and that the notice alerts lab customers of label changes made two months ago with no products removed from shelves.

    By Updated July 9, 2021
  • As EU-wide health technology oversight law nears passage, industry is not pleased

    If passed, the legislation mandates European Union clinical assessments of certain medical devices to inform national-level pricing and reimbursement decisions.

    By July 6, 2021
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    Sarah Silbiger via Getty Images
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    Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods

    Neuroelectrics, Neuros Medical and Onward are among those that secured the regulatory privilege, which speeds the review process for unmet medical needs.

    By July 2, 2021
  • 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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    PMA apps could hit record in 2021, pressuring a pandemic-stressed FDA

    Despite increased workloads from the coronavirus crisis, the agency is also on track to issue record numbers of safety warnings and letters to healthcare providers in 2021, according to a Wells Fargo analysis.

    By July 2, 2021
  • Abbott BinaxNOW home COVID-19 test
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    Abbott

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    COVID-19 antigen testing on par with PCR when used often: NIH-funded study

    The two diagnostic methods were equally effective in detecting SARS-CoV-2 infection. The results could be good news for antigen test makers Abbott, Becton Dickinson and Quidel.   

    By July 1, 2021
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott gets CE mark to sell COVID-19 antigen test directly to consumers in Europe

    The company’s rapid Panbio diagnostic received the marking in January for asymptomatic coronavirus screening. However, the test missed half of COVID-19 cases in people without symptoms, according to a recent Irish study.  

    By June 28, 2021
  • Capitol Hill in Washington, D.C.
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    Permission granted by E.A. Crunden
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    Lawmakers reintroduce diagnostic regulation bill that split the industry

    The VALID Act would create a risk-based regulatory framework for in vitro diagnostics and laboratory-developed tests. ACLA, whose members include Quest and LabCorp, is reviewing the bill but has objected to earlier drafts.

    By June 25, 2021
  • EU clarifies Eudamed rules for legacy and custom-made devices

    The Medical Device Coordination Group has provided information on products placed on the market under frameworks other than MDR and IVDR, which the advisers said should be registered in the database.

    By June 25, 2021
  • An illustration for BioPharma Dive series on gene therapies for different diseases
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    Danielle Ternes/MedTech Dive
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    PerkinElmer, Qiagen latest medtechs to target rapidly growing CRISPR market

    Qiagen launched new products to enable researchers to better analyze the gene editing impact of their work, while PerkinElmer bought viral vector gene delivery company SIRION Biotech to complement its CRISPR portfolio.  

    By June 23, 2021
  • Siemens Healthineers CLINITEST rapid COVID-19 antigen test
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    Courtesy of Siemens Healthineers
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    UnitedHealthcare skimping on COVID-19 test pay: California doctors group

    The California Medical Association says UnitedHealthcare still is not covering the cost of all COVID-19 diagnostic testing, despite state and federal guidelines that require the services to be provided at no cost to patients.

    By June 21, 2021
  • UK extends OK of Innova COVID-19 test criticized by FDA in warning letter

    While U.S. regulators told the public to put Innova tests in the trash, a review by the U.K. counterpart found no problems that warranted further actions.

    By June 18, 2021
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    Sarah Silbiger via Getty Images
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    LetsGetChecked receives EUA for use of at-home COVID-19 collection kit by minors

    The virtual healthcare company, which last week announced $150 million in Series D financing, is competing with companies including LabCorp for the pediatric testing market.

    By June 16, 2021
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    Stefani Reynolds / Stringer via Getty Images
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    MedPAC says lower clinical lab fees don’t impact access, prompting ACLA ire

    The clinical laboratory group, whose members include Quest and LabCorp, contends that MedPAC’s report to Congress contains “biased” commentary that ignores the value of lab tests and importance of timely patient access.

    By June 16, 2021
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott’s Panbio antigen test misses half of asymptomatic COVID-19 cases in Irish study

    The finding led Ireland to recommend against using single, standalone antigen kits for the purposes of such screening.

    By June 15, 2021
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    Sarah Silbiger via Getty Images
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    FDA rejects Verily filing for wrist-worn Parkinson’s clinical trial device

    The sister company of Google developed the feature to collect data on the motor function of Parkinson’s patients in between visits to trial sites. However, the agency questioned the wearable’s ability to have a meaningful effect. 

    By June 14, 2021
  • Transmission electron micrograph of a SARS-CoV-2 virus particle, isolated from a patient.
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    National Institute of Allergy and Infectious Diseases. (2020). “Novel Coronavirus SARS-CoV-2” [Image]. Retrieved from Flickr.
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    FDA blasts Innova for shipping unapproved COVID-19 test, using false or misleading labeling

    The agency hit the California-based medtech with a flurry of actions on Thursday, firing off a warning letter alongside notice of a Class I recall and a press release telling the public to stop using the antigen test. 

    By Updated June 11, 2021
  • California Attorney General Xavier Becerra, President Joe Biden's nominee for HHS secretary, at his confirmation hearing before the Senate health committee.
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    Retrieved from C-SPAN on February 23, 2021
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    HHS warns providers, insurers COVID-19 testing must be free for patients

    The American Clinical Laboratory Association, which includes Quest Diagnostics and LabCorp, has complained that guidance on the topic had only served to muddy what they saw as clear congressional mandates.

    By June 10, 2021