Weekender: FDA warns of patient deaths tied to reusable urological endoscopes

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FDA warns of patient deaths tied to reusable urological endoscopes The agency is sounding the alarm after receiving more than 450 adverse event reports in four years tying patient infections to the devices. Products from Olympus and Karl Storz were cited in the reports. Deaths trigger new Class I recall for 6 Medtronic HeartWare products FDA has now categorized 13 HeartWare products recalled as Class I events in the past 13 months amid a stream of fault reports that have been implicated in the deaths. Liquid biopsies dominate FDA's latest breakthrough device nods Cancer tests feature heavily in the latest round of agency breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status. Suit alleging Medtronic misled FDA over spine fusion can proceed, appeals court says The court ruled the case can go forward on the question of whether the medtech defrauded the agency to gain 510(k) clearance for several products by failing to disclose the devices were intended for use in cervical spine. MDMA, surgeons push Medicare to pull back prior authorization rules The medtech lobby and 39 stakeholders warned CMS that including cervical fusion with disc removal and implanted spinal neurostimulators as new service categories will delay patient access to medically necessary procedures. Recommended For You Improve your recommendations: click here to update your profile. Deep Dive Medtronic's robotic spine market lead threatened as smaller rivals look to edge in Medtronic and Globus Medical are currently in a "two pony race" in the space, Wall Street analysts say, but market share can be stolen as other companies launch systems and adoption grows. Best of What We're Reading Kaiser Health News Fauci Thanks US Health Workers for Sacrifices but Admits PPE Shortages Drove Up Death Toll MobiHealthNews Cleveland Clinic researchers evaluate Smartphone ECG in post AFib ablation care MedPage Today CKD Care Took a Back Seat During Pandemic Politico The big hole in America's plan to fight Covid-19 variants STAT ‘Here to stay’: How the pandemic helped build a burgeoning home testing industry Axios Health care leads the way for top private AI firms 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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