By the Connected Diagnostics Evidence Team 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 …
Software Changes in Connected Diagnostic Devices: Why Version and Workflow Matter
By the Connected Diagnostics Evidence Team Connected diagnostic devices — digital otoscopes, phone-based skin scanners, home hearing tests, and telemedicine intake cameras — run software that changes …
How to Use FDA Device Databases to Verify a Connected Diagnostic Claim
By the Connected Diagnostics Evidence Team You can verify an FDA-related claim on a connected diagnostic device yourself, using two free public databases: the Product Classification Database, which …
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From Image Capture to Clinical Context: Why a Connected Device Does Not Interpret Itself
By the Connected Diagnostics Evidence Team By Connected Diagnostics Evidence Editorial Team What a Connected Device Image Can (and Can't) Tell You A connected device image shows what a lens and …
Medical Device Intended Use and FDA Classification: A Reader’s Guide for Connected Exam Tools
By the Connected Diagnostics Evidence Team Medical device intended use and FDA classification are the two legal concepts that determine what a connected exam tool — like a phone-attached camera used …
How to Read a Diagnostic-Accuracy Study of a Connected Medical Device
By the Connected Diagnostics Evidence Team A diagnostic-accuracy study measures how often a health app or connected device gets it right — and how often it doesn't. Before trusting a diagnostic claim …
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