Sophia Ramirez
Pooled Findings from Recent Observational Studies on Sleep and Male Hormonal Health
Studies Link Reduced Sleep Duration and Poor Sleep Quality to Lower Testosterone in Men
Read More →FDA Clarifies Which Digital Wellness Tools Fall Under Medical Device Regulation
The FDA has spelled out more details on its oversight of digital health products. Its risk-based framework looks at…
Read More →FDA Outlines New Regulatory Expectations for AI-Driven Cardiac Diagnostics and Remote Monitoring Tools
FDA Clarifies Path for Updates to AI Software Used in Heart Monitoring Devices
Read More →FDA Outlines Regulatory Expectations for AI/ML-Based Digital Wellness Tools
The Food and Drug Administration has issued draft guidance that applies its existing rules to AI-powered software…
Read More →What the 2021 USPSTF Colorectal Cancer Screening Recommendation Means
2021 USPSTF Update Lowers Colorectal Cancer Screening Start Age to 45 for Average-Risk Adults
Read More →FDA Clearance Pathways and Evidence for Cardiovascular Wearables
The FDA evaluates consumer wearables that monitor for signs of atrial fibrillation through its Digital Health Center…
Read More →USPSTF Updates Statin Guidance for Adults Ages 40–75 at Risk of Cardiovascular Disease
The U.S. Preventive Services Task Force updated its recommendation on statin use for primary prevention of…
Read More →What Multiple NEJM and JAMA Trials Show on Semaglutide and Cardiovascular Risk
Three trials published in the New England Journal of Medicine tested semaglutide and liraglutide for effects on heart…
Read More →How the FDA Determines Which Wellness Apps Are Regulated as Medical Devices
The FDA regulates digital health applications that qualify as medical devices if their intended use involves…
Read More →FDA Outlines Predetermined Change Control Plans for AI-Enabled Medical Devices
FDA Guidance Details Plans for Updates to AI Software Used in Medical Devices
Read More →Multiple Cohorts Link Short Sleep Duration to Lower Testosterone in Men
Cohort and Experimental Data Link Short Sleep to Lower Testosterone in Men
Read More →FDA Authorizes Reformulated mRNA COVID-19 Vaccines for 2024-2025 Season
FDA Authorizes Updated 2024-2025 COVID-19 Vaccines Targeting KP.2 Variant
Read More →Heart Disease in Men: Answering Common Questions Using Latest CDC Reports
CDC and MMWR Data Show High Rates of Cardiovascular Risk Factors in Middle-Aged U.S. Men
Read More →What Multiple Large Trials Show About Heart Risks in Men Using TRT
What Multiple Large Trials Show About Heart Risks in Men Using TRT
Read More →FDA Clarifies Regulatory Expectations for AI-Driven Digital Wellness Interventions
FDA Clarifies Regulatory Expectations for AI-Driven Digital Wellness Interventions
Read More →FDA Revises Labeling and Monitoring Guidance for GLP-1 Drugs Used in Type 2 Diabetes and Weight Management
FDA Updates Postmarket Safety Monitoring Requirements for GLP-1 Receptor Agonists
Read More →Q&A: FDA-Authorized Digital Therapeutics for Anxiety and Depression – What the Primary Documents Show
Q&A: FDA-Authorized Digital Therapeutics for Anxiety and Depression – What the Primary Documents Show
Read More →FDA Clarifies Regulatory Expectations for AI Tools Used in Heart Disease Prevention
FDA Clarifies Regulatory Expectations for AI Tools Used in Heart Disease Prevention
Read More →CDC Updates Advisory Committee Recommendations for Influenza Vaccination Coverage
CDC Updates Advisory Committee Recommendations for Influenza Vaccination Coverage
Read More →FDA Warns of Dosing Errors and Adverse Events Linked to Compounded GLP-1 Receptor Agonists
FDA Warns of Dosing Errors and Adverse Events Linked to Compounded GLP-1 Receptor Agonists
Read More →FDA Outlines Regulatory Expectations for AI-Driven Digital Tools in Primary Prevention of Heart Disease
FDA Outlines Regulatory Expectations for AI-Driven Digital Tools in Primary Prevention of Heart Disease
Read More →What CDC and WHO Primary Reports State About Daily Sitting Time and Health Metrics
What CDC and WHO Primary Reports State About Daily Sitting Time and Health Metrics
Read More →FDA Warns of Adverse Events Linked to Unapproved Compounded Versions of Ozempic and Wegovy
FDA Warns of Adverse Events Linked to Unapproved Compounded Versions of Ozempic and Wegovy
Read More →What FDA Clearance Actually Means for Digital Mental Wellness Apps
What FDA Clearance Actually Means for Digital Mental Wellness Apps
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