Weekender: Abbott, BD join chorus of COVID-19 test makers claiming diagnostics not impacted by omicron variant

Signup | Forward Weekender Dec.​ 4,​ 2021 | A roundup of this week's most read stories

BROUGHT TO YOU BY — BIOMEDevice Silicon Valley's Leading Medtech Event is Back! This immersive regional event focuses on the latest in medtech, expecting 2,000+ attendees, 200+ exhibitors, and 40+ industry speakers and thought leaders. Get your free expo pass.   Abbott, BD join chorus of COVID-19 test makers claiming diagnostics not impacted by omicron variant Becton Dickinson on Tuesday became the latest testing manufacturer to express confidence that both its rapid antigen and PCR tests will detect the variant, which the World Health Organization says poses a "very high" risk.    FDA finds 'low likelihood' omicron will impact COVID-19 PCR, antigen tests The agency joined the chorus of top testing manufacturers, including Abbott Laboratories, Quidel and Thermo Fisher Scientific, claiming that current coronavirus diagnostics can accurately identify the omicron variant. BD test, others among rapid antigen kits authorized for one-time use by FDA The agency has authorized another three over-the-counter COVID-19 antigen home tests for single use in people with symptoms, furthering the emergence of the kits as an alternative to PCR. IVDR milestone as EU expert panel delivers first opinion on a diagnostic submission The In Vitro Diagnostic Medical Devices Regulation panel, which got off to a rocky start earlier this year, provided a glowing assessment of a test by an undisclosed company that screens plasma donor samples for hepatitis E virus. Cyber playbook sets out strategies for modeling threats to medical devices The FDA-funded guide arrives against a backdrop of calls from the agency for the medtech industry to step up its threat modeling throughout the device lifecycle in order to strengthen cybersecurity and patient safety. Recommended For You Improve your recommendations: click here to update your profile. Deep Dive Medical device security continues to be casualty of hospital-medtech divide FDA says manufacturers and hospitals are both responsible for protecting devices from growing cybersecurity threats. However, healthcare organizations carry a much heavier load. Post-Pandemic Insights for the MedTech Sector As healthcare recovers after COVID-19, questions remain about what lasting effects the pandemic will have on MedTech. Explore the state of the market in this on-demand webinar. Watch Now From Our Library Webinar - on demand How Pharma Can Ease the Pressure on Patient Support Programs IQVIA Webinar - on demand MedTech Market Outlook and Strategy Recommendations for 2022 Clarivate Trendline COVID-19 diagnostics surge as industry prepares for spike in at-home testing Veeva Systems View all resources Best of What We're Reading The New York Times In Biden’s Plan for Free Rapid Tests, Legwork Will Be Required Bloomberg Carlyle Acquires 50% Stake in Medical-Device Maker Resonetics STAT Reforms needed for FDA’s regulation of medical devices MedPage Today Artificial Intelligence Tool Gets High Marks in Reading Mammograms CNBC Minnesota reports second U.S. omicron Covid case in resident who traveled to New York City Reuters U.S. to require private health insurance companies cover at-home COVID-19 tests Suggest a story we should read Dive Into a Topic Medical Devices Policy & Regulation Clinical Trials Manufacturing Legal M&A Research Diagnostics Digital Health Imaging Share MedTech Dive: Daily Dive with others and get rewarded. You've referred 0 readers. To become an official Dive Insider, just successfully refer 10 contacts to MedTech Dive: Daily Dive. Here's your link to share: https://www.medtechdive.com/signup/insiders/?signup_referred_by=5f93078d7aa51972095c9316

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