FDA CDS Guidance: What’s Changed and Who Cares
What the 2026 FDA CDS guidance covers (and what it doesn’t) The FDA’s January 2026 update to its Clinical Decision Support (CDS) guidance is not […]
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General Wellness vs Medical Device in 2026: FDA Rules for Wearables, Apps, and Claims
Why the “wellness vs device” line matters For companies building wearables and health apps, the distinction between general wellness products and medical devices is not […]
TEFCA in 2026: What QHIN Expansion Means for Digital Health Vendors and Providers
TEFCA basics The Trusted Exchange Framework and Common Agreement (TEFCA) is the U.S. government’s attempt to create a nationwide, interoperable floor for health information exchange. […]
Cybersecurity Incidents in Connected Health: Lessons from 2025 for Patient Monitor Vendors and Ecosystems
Why Patient Monitors Became a Cybersecurity Flashpoint in 2025 In 2025, connected patient monitors moved from the background of hospital infrastructure to the center of […]
Connected Health 2025 – 12 Signals That Will Shape Strategy in 2026
Digital Health Economy & Reimbursement: What Fundamentally Changed in 2025 The defining shift of 2025 was not technological, but economic. Digital health finally moved from […]
How Vibration Therapy Works for Erectile Dysfunction
Introduction: Can Vibration Therapy Help Erectile Dysfunction? Erectile dysfunction (ED) affects millions of men in the United States as well as all over the world, […]
Varenicline + Bupropion Combination for Alcohol Dependence
The Dopamine Rationale Alcohol Use Disorder has long been understood as a condition shaped by both psychological factors and deep neurobiological changes, yet many of […]
Tadalafil 5 mg Daily for Premature Ejaculation: A 2025 Meta-analysis Dampens Enthusiasm for Off-Label Prescribing
Why Earlier Evidence Suggested Tadalafil Might Help PE For nearly two decades, tadalafil has been prescribed off-label for remature ejaculation in men who also present […]
SOUL: Oral Semaglutide (Rybelsus) Demonstrates First-Ever Reduction in MACE for High-Risk Type 2 Diabetes Patients
Why the SOUL Trial Represents a Breakthrough for Oral GLP-1 Therapy The SOUL trial positions oral semaglutide in an entirely new therapeutic category. Until now, […]
Sildenafil under Pharmacovigilance Scrutiny: Unexpected Signals of Melanoma, Aortic Dissection, and Rare Coagulopathies in FAERS
How to Read a Pharmacovigilance Signal: What FAERS Can and Cannot Tell Us Pharmacovigilance databases such as the FDA Adverse Event Reporting System (FAERS) occupy […]