Weekender: FDA warns of false positive risk of Abbott COVID-19 lab tests

Signup | Forward Weekender Sept.​ 25,​ 2021 | A roundup of this week's most read stories

BROUGHT TO YOU BY — Definitive Healthcare Fast & accurate market segmentation Get the affiliations and payor info you need for precision execution of product launches, sales strategies and marketing campaigns. See it now.   FDA warns of false positive risk of Abbott COVID-19 lab tests CEO Robert Ford called rollout of the analyzer connected to the tests as a growth driver for the diagnostics business in July. Medtronic embolization device hit with another Class I recall, 2 deaths cited The action expands a 2020 recall of the brain aneurysm treatment and comes five months after the agency approved an updated version of the technology. GE Healthcare to buy BK Medical for $1.45B The deal is aimed at expansion beyond diagnostics into surgical and therapeutic interventions, with high-single-digit return on invested capital anticipated by year five, CEO Kieran Murphy said. Boston Scientific CEO: 'Unprecedented' shutdown from delta to hit Q3 CEO Michael Mahoney cited a six- to seven-week impact from the variant beginning in August, in line with other warnings from medtechs. He said meeting full-year sales estimates is "still possible." Abbott gets FDA nod, faces uphill climb taking on Edwards, Medtronic in TAVR market The challenge for Abbott as the newcomer is to take share in a relatively mature market dominated by well-set incumbents, without evidence of superiority. BROUGHT TO YOU BY — MilliporeSigma New resource hub for med device raw materials & expertise Manufacturers partner with us for quality materials, supply chain security, and production support services. We can supply a comprehensive solution of application-relevant materials for R&D, scale-up, production and QC through our global distribution network. Search our resources & product areas. From Our Library Trendline How medtechs are navigating the sales environment after the pandemic View all resources Best of What We're Reading The New York Times A ‘Race-Free’ Approach to Diagnosing Kidney Disease NPR NY Hospitals Worry About Staff Shortages As Monday Vaccine Deadline Approaches MedCity News Remote patient monitoring use is on the rise, but reimbursement needs to catch up The Verge Most dermatology algorithms don’t have transparent data The Hill Biden under pressure to expand rapid COVID-19 testing Kaiser Health News At an Overrun ICU, ‘the Problem Is We Are Running Out of Hallways’ 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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