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FDA Clarifies When Wellness Apps and Wearables Fall Under Medical Device Regulation
The FDA applies a risk-based approach to digital health technologies. It generally exercises enforcement discretion…
Read More →What Is Skin Laxity, What Causes It, and Is It Reversible?
Skin laxity is the loss of firmness and elasticity that lets skin sag, fold, or feel less resilient.
Read More →Pooled Trial Data Link GLP-1 Therapies to Reduced Major Adverse Cardiovascular Events in Male Patients
Major Trials Associate GLP-1 Receptor Agonists With Lower Cardiovascular Event Rates in Men With Type 2 Diabetes
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 Warns Consumers About Hidden PDE5 Inhibitors in Over-The-Counter Male Enhancement Products
The U.S. Food and Drug Administration has identified multiple male sexual enhancement supplements that contain…
Read More →Pooled Trial Data Link Regular Resistance Exercise to Modest Improvements in Testosterone and Insulin Sensitivity in Men Ages 40–65
Many women notice the men close to them start to talk about lower energy or slower recovery once they reach their 40s.…
Read More →Sleep and Testosterone: Answering Reader Questions from CDC and NIH Primary Reports
CDC and NIH sources state that adults need 7 or more hours of sleep per night. NIH materials link sleep restriction…
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 →FDA Clarifies Regulatory Expectations for AI Tools in Heart Disease Prevention
FDA Issues Draft Guidance on AI/ML Software for Cardiovascular Risk Assessment
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 →Heart Disease in Men: Answering Common Questions from Latest CDC Reports
What do CDC and MMWR data reveal about cardiovascular risk factors in men?
Read More →Synthesis of RCTs Shows Modest Improvements in Blood Pressure and Glucose from Wearable Trackers in Men
Synthesis of Trials Links Wearable Trackers to Modest Step Gains and Select Cardiometabolic Shifts in Overweight Adults
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