Weekender: Philips ventilator recall labeled Class I by FDA, second in as many weeks

Signup | Forward Weekender Aug.​ 7,​ 2021 | A roundup of this week's most read stories

BROUGHT TO YOU BY — Guidehouse Bringing Data to Life How an innovative segmentation model can enable tech-savvy life sciences companies to better serve the healthcare sector. Read now.   Philips ventilator recall labeled Class I by FDA, second in as many weeks The recall was triggered by identification of a risk that ventilators will provide lower oxygen flow. The Class I event is separate from FDA's designation in July of a recall impacting millions of Philips sleep apnea and ventilator devices. Digital health, heart disease devices feature in latest FDA breakthrough designations Philips, Endologix and several smaller companies in recent weeks won the regulatory privilege, giving them speedier review of products that may provide more effective treatments for life-threatening conditions. Hillrom reverses course, will finalize $375M BardyDx acquisition The decision ends a months-long fight by Hillrom to back out of the buy due to substantially reduced Medicare rate cuts for long-term cardiac monitoring. Hillrom expects the deal to close in the coming weeks. Sponsored Content by MD&M West Discover the next-gen design in digital health and wearables tech Experts from medtech present on the latest innovation in personal and outpatient healthcare. Register now. Boston Scientific, Stryker get extra year of add-on payments as CMS adjusts to pandemic Comments "overwhelmingly supported" the plan to use pre-pandemic data on the cost of inpatient stays to inform CMS' rates for fiscal 2022. FDA ups premarket application user fees by 2.5% for FY 2022 The base PMA fee will be $329,000, though the increase is far less than the 7% hike instituted last year. From Our Library Playbook The Roadmap to Clinical, Regulatory, and Commercial Success in Medical Device Clinical Trials Medidata View all resources Best of What We're Reading ProPublica Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous The Verge A recall of Philips respiratory devices has left users stranded CNN US planning to expand coronavirus testing, Fauci says 360Dx Quidel Q2 Revenues Dip 12 Percent; Misses on Revenues and EPS Estimates The Wall Street Journal Delta Variant Increases Demand and Wait Times for Covid-19 Tests STAT With a nudge from AI, ketamine emerges as potential rare disease drug 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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