COVID-19
FDA ‘working around the clock’ with COVID-19 Workload, All Reviews Impacted: CDRH Chief Dive Brief: FDA continues to struggle in 2021 in balancing its...
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All posts tagged "Regulatory"
Artificial Intelligence
AI, Digital Health Feature in Latest Batch of FDA Breakthrough Device Designations FDA has issued another batch of breakthrough device designations. The latest crop...
Digital Health
Connected Care and Telehealth Policy Outlook for the Year Ahead With the connected care and telehealth coverage dependent on COVID-19 public health emergency (PHE)...
Clinical Trials
Startup Making Digital Therapeutic for Pelvic Floor Disorders Raises $17M Renovia, a digital health startup that developed an app-based program for urinary incontinence, raised...
Artificial Intelligence
Europe Lays Out Plan for Risk-Based AI Rules to Boost Trust and Uptake European Union lawmakers have presented their risk-based proposal for regulating high...
COVID-19
FDA late Wednesday announced emergency use authorizations for Abbott, Becton Dickinson and Quidel rapid COVID-19 antigen tests intended for serial screening of asymptomatic individuals...
Digital Health
Vision-Based Monitoring Service Receives FDA Clearance for Vital Signs Product Vision-based patient monitoring service Oxehealth has been granted De Novo clearance by the US...
Digital Health
New Surveys Suggest Strong Support For Telehealth, But Policymakers Have Questions Over the past year, millions of Americans have become accustomed to a new...
Digital Health
Backed by Amazon Care and Intermountain, a New Coalition Lobbies for Policy Changes Around At-Home Care The telehealth boom has made one thing clear:...
Digital Health
Qardio Receives US FDA Clearance for QardioCore Continuous Ambulatory ECG Qardio has announced that the US Food and Drug Administration (FDA) has granted the...
