Weekender: FDA updates impact of mutations on COVID-19 tests, adds Cepheid to list of affected products

Signup | Forward Weekender April​ 3,​ 2021 | A roundup of this week's most read stories

BROUGHT TO YOU BY — MedTech Dive's studioID Why Life Sciences Orgs Are Leveraging Digital QMS Explore why leading life sciences companies are implementing Digital QMS to increase efficiency and improve global visibility in this webinar: Learn more.   FDA updates impact of mutations on COVID-19 tests, adds Cepheid to list of affected products A new agency webpage features the latest information about the potential impact of viral mutations on molecular diagnostics such as Cepheid's Xpert line of rapid SARS-CoV-2 tests. Medtronic's Harmony pulmonary valve wins FDA approval The device is the first non-surgical heart valve cleared in the U.S. to treat a severe form of pulmonary valve regurgitation that usually results from a congenital heart defect. FDA panel to probe Endologix, broader stent graft safety in Q4 The agency is mulling further action to address blood leak risks with the medtech's grafts for abdominal aortic aneurysms and surveillance strategies for all AAA endovascular grafts. Medtronic and Cook also sell the products. Medtronic inks value-based care pact with Spectrum Health The risk-based deal, initially focused on cardiac resynchronization therapy, will have the medtech giant paying the provider if certain patient metrics are not met, according to a spokesperson for the health system. A year into the pandemic, advanced cancer diagnoses are rising Research from radiation oncologists and molecular pathologists add to evidence showing that many people skipped getting cancer screenings in 2020 as they avoided going to the doctor to minimize the risk of COVID-19 infection. From Our Library Webinar - on demand Digital QMS in Life Science Organizations IQVIA View all resources Best of What We're Reading Axios The fourth wave is here The New York Times Why Virus Tests at One Elite School Ran Afoul of Regulators MobiHealthNews European med tech industry calls for patient access to innovation to be safeguarded Axios Advocates warn: The clock is ticking on new variants The New York Times ‘It Felt Like Deception’: An Elite NYC Hospital Charges Huge Virus Test Fees TCTMD AI in Cardiology: Where We Are Now and Where to Go Next 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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