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READ NOW Featured Stories Bookmark 13 May 2024 News FDA Warns: Government-Funded COVID-19 Test Not On Cue By Elizabeth Orr The US FDA is warning against the use of Cue Health’s COVID-19 test, which was developed and manufactured with $481m of government funding. A recent inspection found unauthorized alterations to the product. Regulation Safety Enforcement Bookmark 13 May 2024 Interviews Hospital At Home: Great On Paper, Not In Practice By Hannah Daniel To avoid a wider health equity gap for home-use devices, companies should make social determinants of health a key consideration in device development, former nurse Amy Hester says. Diversity & Inclusion Regulation FDA Bookmark 13 May 2024 News Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses By Vibha Sharma Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies. Egypt Clinical Trials Regulation Bookmark 10 May 2024 News News We’re Watching: UK Plans Digital Health Guidance, FDA Warns Against Getinge/Marquet Cardiac Devices By Natasha Barrow , Brian Bossetta , Hannah Daniel and Elizabeth Orr This week, MHRA and NICE released results from their first survey of potential digital health tool users; the FDA warned against using Getinge/Marquet cardiac devices; and Illumina announced plans to hand its Grail spin-off to existing shareholders. Commercial Regulation Restructuring Spotlight On Conferences 24 Apr 2024 Analysis At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use By Marion Webb At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy. Innovation In Vitro Diagnostics ‘Biggest Transformation In The History Of Medicine’: Oncologist And Cardiologist Talk AI-Enabled Health Care A More Cautious Approach To AI, And Other Policy And Regulation Trends From HIMSS 24 Creating Standards For Responsible AI In Health Care Imagining Cybersecurity As An Ecosystem: From Regulations To Resiliency Latest News EU Announces Fifth MDR Notified Body Designation In Five Weeks 2 hours ago FDA Warns: Government-Funded COVID-19 Test Not On Cue 16 hours ago Hospital At Home: Great On Paper, Not In Practice 16 hours ago Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses 22 hours ago Digital Health Review Founder Blair Hirst Focuses On Health Equity 10 May 2024 News We’re Watching: UK Plans Digital Health Guidance, FDA Warns Against Getinge/Marquet Cardiac Devices 10 May 2024 Remanufacturing Guidance Adds Info On Premarket Requirements For Remanufacturers 10 May 2024 Notified Body Numbers Continue To Shoot Upwards As Turkey Gains Third Certification Body 10 May 2024 See All Medtech Insight Podcasts This Episode: Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics. More Podcasts Data Trackers Mergers and Acquisitions Approvals Venture FundingGuidances US FDA Warning Letters Medtech Financing US Breakthrough Devices and Approvals Meddevicetracker Reports Advertisement Global Device Regulation 14 May 2024 News EU Announces Fifth MDR Notified Body Designation In Five Weeks By Amanda Maxwell The latest EU organization to be named under the Medical Device Regulation is based in Austria. Europe EU 10 May 2024 Interviews Digital Health Review Founder Blair Hirst Focuses On Health Equity By Elizabeth Orr As a biomedical engineer, Blair Hirst saw how health technology could help patients – and how some communities were slowest to benefit. As founder of the Digital Health Review, she now works to improve equity in health care spaces. Policy Leadership 10 May 2024 News Remanufacturing Guidance Adds Info On Premarket Requirements For Remanufacturers By Hannah Daniel After clarifying what a remanufactured device is in its 2021 draft guidance, FDA’s final guidance adds information about regulatory requirements for companies whose devices qualify as remanufactured. Guidance Documents FDA 10 May 2024 News Notified Body Numbers Continue To Shoot Upwards As Turkey Gains Third Certification Body By Amanda Maxwell The designations of notified bodies are coming fast and furious, with four announcements in a month. Europe EU See All Digital Health 10 May 2024 Interviews Digital Health Review Founder Blair Hirst Focuses On Health Equity By Elizabeth Orr As a biomedical engineer, Blair Hirst saw how health technology could help patients – and how some communities were slowest to benefit. As founder of the Digital Health Review, she now works to improve equity in health care spaces. Policy Leadership 09 May 2024 Interviews Medtech Connect Episode 15: Digital Trust By Hannah Daniel In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones. Cybersecurity Digital Health 09 May 2024 Interviews...