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BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test

1. BD receives FDA 510(k) clearance for BD Veritor™ COVID-19 test. 2. The test delivers digital results in about 15 minutes. 3. 510(k) clearance replaces the current EUA version starting in fall 2025. 4. This clearance enhances diagnostic tools for healthcare providers. 5. BD aims to improve patient outcomes with rapid testing solutions.

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Why Bullish?

The FDA clearance validates BD's ongoing innovation in diagnostics, potentially boosting sales and market share. Historical precedent shows FDA approvals often lead to price increases, as seen with rapid tests during COVID-19 surges.

How important is it?

The article reflects a significant advancement in BD's product offerings, likely to drive future revenue growth. FDA approvals in the healthcare sector can significantly influence investor confidence and stock performance.

Why Long Term?

The transition to 510(k) opens new markets and solidifies BD's position ahead of competitors. Long-term diagnostics demand remains strong, especially with ongoing health concerns.

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New CLIA-Waived Test Delivers Digital Results to Support Timely Clinical Decision-Making, /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic individuals in about 15 minutes at doctors' offices, urgent care centers, retail clinics and other convenient points of care. BD announced it has received FDA 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic individuals in about 15 minutes at doctors’ offices, urgent care centers, retail clinics and other convenient points of care. The BD Veritor™ System for SARS-CoV-2 has been available under Emergency Use Authorization (EUA) from the FDA since September 2020. The new 510(k) clearance will eventually replace the current EUA version of the test, starting in early fall 2025. "This FDA clearance is part of our ongoing commitment to support health care providers with reliable, rapid diagnostic tools," said Nikos Pavlidis, worldwide president of BD Diagnostic Solutions. "The BD Veritor™ System for SARS-CoV-2 has proven to be a reliable COVID-19 test with a streamlined workflow and clear digital results, helping clinicians make confident and timely decisions that can help improve patient outcomes." The BD Veritor™ System for SARS-CoV-2 is a chromatographic, digital lateral flow immunoassay that delivers objective, easy-to-read results using the BD Veritor™ Plus Analyzer. The test is intended for use in CLIA-waived environments and provides results from nasal swab specimens from patients within six days of symptom onset.For more information or support, customers can contact BD Customer Service at 800-638-8663.About BDBD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinsonContacts:SOURCE BD (Becton, Dickinson and Company) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In

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