Weekender: Boston Scientific's ICD recall gets 2nd Class I label from FDA

Signup | Forward Weekender Feb.​ 27,​ 2021 | A roundup of this week's most read stories

Boston Scientific's ICD recall gets 2nd Class I label from FDA A new agency notice covers a fault that allows moisture to enter the medical device, causing it to short circuit when it tries to shock the patient. Boston Scientific has not received reports of injuries or deaths linked to the problem. Hillrom patient lift tied to 2 deaths, designated as Class I recall The device, used to move patients in healthcare facilities from one room to another in a sitting position, could become detached from its ceiling rail system causing the motor or patient to fall.  FDA lays path to weigh virus variant impact on COVID-19 test results The agency wants diagnostic companies to factor the potential for variants to evade detection into their test development and monitoring, Center for Devices and Radiological Health chief Jeff Shuren said. UK adopts medical device legislation, setting stage for new databases and sanctions Politicians framed the new law as furthering efforts to fix failings that delayed regulatory responses to safety problems with products including pelvic mesh. Medtronic sees capital equipment uptick despite latest coronavirus surge Still, CFO Karen Parkhill observed that in February the company has "not yet seen a turnaround" as a result of severe winter weather in the U.S. Featured Resources FROM: BioReference Laboratories Scarlet Health: Sample collection services at patients' homes Introducing Scarlet Health Learn how in-home specimen collection works How Scarlet is reimagining healthcare delivery Best of What We're Reading Healthcare Dive Becerra distances himself from 'Medicare for All,' appears on track for confirmation MedCity News Hospitals could lose $53B this year — and that’s in the best-case scenario MobiHealthNews FDA's enforcement discretion for digital health is more ambiguous than ever in 2021 The Mercury News California has quietly ended its COVID-19 testing partnership with Verily MedPage Today ECG Patch Boosts Afib Diagnoses in Older Folks MobiHealthNews Global lessons learned about DTx implementation, reimbursement 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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