Introduction: The Importance of Clarity in Blood Pressure Device and Software Classification   As wearable technology advances, more devices are integrating blood pressure features—from clinical-grade monitors to smartwatches that “notify” users of potential changes. But not all blood pressure devices are created—or regulated—the same.  Understanding the difference between a blood pressure measurement device (FDA product code DXN) and a hypertension machine learning-based no

Why Verification Matters in BP Devices   Blood pressure (BP) measurement is a foundation of cardiovascular care. But not all BP devices are created equal — increasingly, clinicians and patients recognize that a blood pressure reading is only useful if it’s accurate.  To address market confusion around which BP monitors are reliable, the American Medical Association (AMA) introduced the Validated Device Listing (VDL) . The VDL is a free resource that helps clinicians, health

Introduction: A New Standard on the Horizon   On January 6, 2025 , the FDA released a draft guidance  titled Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations . This draft guidance updates and expands upon earlier 510(k) and performance expectations for pulse oximeters, placing renewed emphasis on accuracy across skin pigmentation  and non-disparate performance .   Crucially, the draft does