Ethan Shields
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FDA Issues Draft Guidance on AI/ML Software for Cardiovascular Risk Assessment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 →FDA Clarifies Regulatory Expectations for Software Monitoring Cardiovascular and Metabolic Parameters in Men
FDA Clarifies Regulatory Expectations for Digital Health Technologies in Remote Physiologic Monitoring
Read More →FDA Clarifies Oversight of Software and Devices Marketed for Digital Wellness Tracking
FDA Guidance Excludes Low-Risk Wellness Technologies From Medical Device Regulation
Read More →CDC Issues Shared Clinical Decision-Making Guidance for RSV Vaccines in Older Adults
CDC Updates RSV Vaccine Recommendations for Adults Aged 60 and Older
Read More →FDA Warns of Hidden Ingredients in Online Erectile Dysfunction Products
FDA Updates Tracking of Tainted Sexual Enhancement Products Containing Undeclared PDE5 Inhibitors
Read More →FDA Warns of Hidden PDE5 Inhibitors and Anabolic Steroids in Over-the-Counter Male Supplements
FDA Warns of Hidden PDE5 Inhibitors and Anabolic Steroids in Over-the-Counter Male Supplements
Read More →FDA Warns of Undeclared PDE5 Inhibitors in OTC Male Enhancement Products
FDA Warns of Undeclared PDE5 Inhibitors in OTC Male Enhancement Products
Read More →FDA Mandates Revised Cardiovascular and Prostate Cancer Risk Information in Testosterone Therapy Labeling
FDA Requires Updated Safety Labeling for Testosterone Replacement Therapy Products
Read More →FDA Highlights Post-Approval Cardiovascular and Gastrointestinal Data for Semaglutide
FDA Highlights Post-Approval Cardiovascular and Gastrointestinal Data for Semaglutide
Read More →FDA Detects Hidden Prescription Ingredients in Over-the-Counter Male Sexual Enhancement Products
FDA Detects Hidden Prescription Ingredients in Over-the-Counter Male Sexual Enhancement Products
Read More →FDA Warns Consumers of Hidden Sildenafil and Tadalafil in Over-the-Counter Male Sexual Enhancement Products
FDA Warns Consumers of Hidden Sildenafil and Tadalafil in Over-the-Counter Male Sexual Enhancement Products
Read More →FDA Clarifies Regulatory Expectations for AI-Powered Digital Health Tools
FDA Clarifies Regulatory Expectations for AI-Powered Digital Health Tools
Read More →FDA Outlines Regulatory Expectations for AI Tools Used in Heart Disease Prediction
FDA Outlines Regulatory Expectations for AI Tools Used in Heart Disease Prediction
Read More →FDA Clarifies Evidence Standards for Digital Tools Used in Remote Monitoring and Preventive Health
FDA Clarifies Evidence Standards for Digital Tools Used in Remote Monitoring and Preventive Health
Read More →FDA Proposes New Framework for Regulating AI in Consumer Digital Health Tools
FDA Proposes New Framework for Regulating AI in Consumer Digital Health Tools
Read More →