Weekender: FDA finds 3 COVID-19 tests that fail to detect the omicron variant

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BROUGHT TO YOU BY — MedTech Dive's studioID The Future of Medtech Customer Relationships Explore how medtech leaders are extending the value of pandemic-era relationship management to boost efficiency and customer loyalty in this playbook.   FDA finds 3 COVID-19 tests that fail to detect the omicron variant Diagnostics from Applied DNA Sciences, Meridian Bioscience and Tide Laboratories are not able to detect omicron, causing false negative results, and should not be used, the agency said. Medtronic's stock price falls nearly 9% following FDA warning letter The medtech giant's stock continued to drop following the Wednesday announcement, while insulin pump rival Tandem Diabetes Care's was boosted by roughly 9.5% when the market closed Thursday. 3 medtech markets poised to thrive in 2022 despite renewed COVID-19 pressures While the emergence of the omicron variant is muddying next year's medtech outlook, analysts have identified three niches within the sector best positioned to successfully weather the continued strains on the healthcare system. Medtronic's Covidien initiates ventilator recall due to manufacturing error Puritan Bennet 980 series ventilators can become inoperable during use, according to the FDA recall database. The agency labeled the recall a Class I event, the third such classification for the product since 2015. Neurostimulator to treat stroke fails to gain FDA advisory panel support The panel questioned whether modifications in the pivotal trial for the device from BrainsGate, a company that attracted early investment from Boston Scientific and J&J, could have compromised the study. From Our Library Webinar - on demand MedTech Market Outlook and Strategy Recommendations for 2022 Clarivate View all resources Best of What We're Reading The New York Times Affordable Coronavirus Tests Are Out There, if You Look TCTMD As COVID-19 Drags on, the Cardiology Fallout May Haunt for Years The Independent Omicron spread could see 100,000 operations cancelled in England this winter MobiHealthNews From Alexa to COVID-19 tests, Amazon expands healthcare aspirations in 2021 Politico HHS forecast shows Omicron stretching U.S. Covid testing supply Wall Street Journal CDC’s Early Covid-19 Test Hampered by Design Flaw, Contamination 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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