What Does It Mean When a Diagnostic Device Is "AI-Enabled"? An AI-enabled diagnostic device is a piece of software or hardware that uses machine learning to help produce a health-related output — a …
Store-and-Forward Video Otoscopy: What a Remote Review Workflow Requires
Medical note: This article explains how a remote review process works. It does not diagnose ear problems or tell you what to do about symptoms. If you or your child has sudden severe ear pain, …
Continue Reading about Store-and-Forward Video Otoscopy: What a Remote Review Workflow Requires →
Software Changes in Connected Diagnostic Devices: Why Version and Workflow Matter
Connected diagnostic devices — digital otoscopes, phone-based skin scanners, home hearing tests, and telemedicine intake cameras — run software that changes over time. Because performance evidence is …
Mobile Clinical Microscopy: How to Read Validation Evidence for Point-of-Care Tools
Mobile clinical microscopy uses a phone- or handheld-based microscope to examine samples outside a lab, but its accuracy depends entirely on how well it was validated. Reading validation evidence …
How to Use FDA Device Databases to Verify a Connected Diagnostic Claim
You can verify an FDA-related claim on a connected diagnostic device yourself, using two free public databases: the Product Classification Database, which shows a device's regulatory category, and the …
Continue Reading about How to Use FDA Device Databases to Verify a Connected Diagnostic Claim →
From Image Capture to Clinical Context: Why a Connected Device Does Not Interpret Itself
By Everyday Imaging Evidence Editorial Team · Reviewed September 8, 2026 What a Connected Device Image Can (and Can't) Tell You A connected device image shows what a lens and sensor capture — not …