Diagnostics: Page 23


  • The United States Capitol in February 2020
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    Megan Quinn/MedTech Dive
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    FDA user-fee bill goes to House; Senate committee draft revamps diagnostic regulations

    The House Energy and Commerce Committee unanimously passed a bill to reauthorize the FDA’s user-fee amendments for the next five years. A Senate committee draft of the bill would add substantive changes.

    By May 19, 2022
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    Justin Sullivan via Getty Images
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    LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19

    The kit allows individuals to self-collect nasal swab samples at home to send to LabCorp, which will test for the presence of influenza A and B, respiratory syncytial virus and SARS-CoV-2.

    By May 18, 2022
  • 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
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images
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    FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests

    Woodside Acquisitions recalled two different rapid antigen test kits last month and sent emails to distributors requesting them to immediately return all unused products for a refund.

    By May 16, 2022
  • U.S. Government Accountability Office
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    Government Accountability Office Building” by kafka4prez is licensed under CC BY-SA 2.0
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    FDA needs testing enforcement discretion policy to improve crisis response, GAO finds

    The U.S. Government Accountability Office has recommended that the FDA develop a policy about when to start and stop enforcement discretion for unauthorized tests to avoid some of the problems it faced during the pandemic.

    By May 13, 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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    Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market

    The company plans to work toward approvals of transplant assays for other pathogens including the BK virus and Epstein-Barr virus to provide quantitative assessments of potential threats to patients.

    By May 12, 2022
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    400tmax via Getty Images
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    Roundup: As procedures rebound, supply chain, staffing challenges set to continue for medtechs

    Procedure-driven companies saw sales recover at the end of the first quarter, while diagnostics businesses reported increased sales of COVID-19 tests due to the omicron surge in January.

    By Updated May 19, 2022
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    400tmax via Getty Images
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    Earnings week 3: Procedure rebounds, stock price declines, iRhythm’s comeback

    AtriCure and Axonics reported procedure volume rebounds and both firms increased their 2022 forecasts. Still, the share prices of the companies dropped late last week.

    By May 9, 2022
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    Carl Court via Getty Images
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    EU task force posts guidance on significant IVDR changes to address a top priority for industry

    The guidance will help manufacturers determine if a change to an in-vitro diagnostic is significant and will require certification by a notified body after the new regulations go into effect on May 26. 

    By May 6, 2022
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images
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    FDA reveals another Class I COVID-19 test recall as SML pulls 209,000 kits from the market

    The SML notice comes one week after the FDA shared details of a recall of 311,100 Celltrion tests that may have been sent to unauthorized users that lack CLIA certification.

    By May 5, 2022
  • Abbott Laboratories
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    Courtesy of Abbott
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    FDA clears Abbott’s 4-in-1 Alinity PCR test for sexually transmitted infections

    Abbott is pitching the assay as a way for healthcare providers to gain a fuller picture of a person’s health from a single test and create the optimal treatment plan.

    By May 5, 2022
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    400tmax via Getty Images
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    Hologic, Thermo Fisher, Qiagen quarterly sales beat estimates on COVID-19 test revenue

    Still, the companies warned demand for testing will decline quickly for the remainder of 2022. 

    By May 3, 2022
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images
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    FDA labels Celltrion’s latest recall of 310,000 COVID-19 tests as a Class I event

    The recall stems from the fact that the emergency authorization of the Point of Care DiaTrust COVID-19 Ag Rapid Test only covers use by laboratories with CLIA certification.

    By May 2, 2022
  • A C-arm system is used for imaging in this rendering.
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    FURKAN TELLIOGLU via Getty Images
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    GE Healthcare, Medtronic turn to outpatient care in new partnership

    The companies agreed to a collaboration on ambulatory surgery centers and office-based labs as more procedures are shifting to outpatient care settings. 

    By April 29, 2022
  • The U.S Capitol Rotunda is in front of a designed background of $100 bills.
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    Getty via Getty Images
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    ACLA, AdvaMed urge Congress to immediately replenish COVID-19 testing fund

    Joining a coalition of more than 60 organizations, the lab and medtech groups warned congressional leaders the funding expiration puts the most vulnerable Americans at risk of losing resources to diagnose new infections.

    By April 28, 2022
  • GE Healthcare hit by supply chain constraints, inflation pressures

    “We’re operating in a challenging macro environment,” GE CEO Larry Culp said during a first-quarter earnings call, while also noting COVID-19 lockdowns in China and lower sales volumes in Russia and Ukraine impacted results. 

    By April 26, 2022
  • Philips commits more cash to recall as DOJ issues subpoena

    The Dutch conglomerate said Monday that it is cooperating with an April 8 subpoena from the U.S. Department of Justice seeking information related to the Respironics recall of sleep apnea devices and ventilators.

    By April 25, 2022
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images
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    FDA warns about noninvasive prenatal tests, but analysts see minimal industry impact

    Given that the FDA’s warning involves improper test use and lacks new data, Craig-Hallum analysts expect it to have little impact on Natera, one of the companies competing for the market.

    By April 22, 2022
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott reports $900M Q1 revenue beat on COVID-19 test demand

    The company’s 2022 guidance now includes testing sales of about $4.5 billion, versus $2.5 billion previously, which it anticipates will largely occur in the first half of the year.

    By April 20, 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 authorizes first COVID-19 breathalyzer test, clearing path to 3-minute results

    After researchers began looking into ways to detect COVID-19 in breath samples, InspectIR Systems’ test will be the first FDA-authorized breathalyzer. 

    By April 18, 2022
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    Quinn Rooney via Getty Images
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    COVID-19 testing landscape changes as omicron subvariant spreads

    While BA.2 is spreading in the U.S., there are few signs of a surge at the scale of omicron’s peak in January. Nonetheless, Quidel reported record COVID-19 test sales for the first quarter as the FDA makes plans for the pandemic’s end.

    By April 18, 2022
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    Carl Court via Getty Images
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    With IVDR looming, EU prioritizes guidance on legacy devices and Eudamed transition

    A staggered implementation of IVDR has left questions about how legacy tests put on the market will be regulated, and how information will be exchanged until the Eudamed medical device database is fully functional. 

    By April 13, 2022
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    Sean Gallup / Staff via Getty Images
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    Majority of diagnostic companies still implementing IVDR as deadline nears: survey

    Eighty-five percent of respondents said they are implementing the new requirements, finds a survey from Climedo Health and TRIGA-S Scientific Solutions. But most are either familiar or very familiar with the regulations.

    By April 12, 2022
  • Wall Street
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    Spencer Platt via Getty Images
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    Abbott, Intuitive and J&J start medtech earnings season against a turbulent backdrop

    The results will shed light on whether elective surgery recovery is enough to offset a range of headwinds, such as shortages of key components and rising freight costs.

    By April 12, 2022
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    Permission granted by Quidel Corporation
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    ‘One for the record books’: Quidel posts $1B in revenue, beating previous high by nearly $200M

    Despite the record quarter for the diagnostics company, William Blair analysts wrote Quidel hit the $1 billion mark “for the first and likely last time for quite a while.”

    By , Updated May 5, 2022
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    Sarah Silbiger via Getty Images
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    FDA sees ‘appropriate’ transition period for COVID-19 test EUAs when public health emergency ends

    The FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to end their authorizations, in anticipation of U.S. public health emergency declarations stopping.

    By April 7, 2022