By the Connected Diagnostics Evidence Team 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 …
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 …
Inter-Rater Agreement in Digital Otoscopy: What It Measures and What It Does Not
By the Connected Diagnostics Evidence Team What Does “Inter-Rater Agreement” Actually Measure? Inter-rater agreement measures how often two or more reviewers reach the same conclusion when …
Mobile Clinical Microscopy: What Research Shows About Point-of-Care Disease Detection
By the Connected Diagnostics Evidence Team Mobile Clinical Microscopy: Can a Phone Camera Actually Detect Disease? By Connected Diagnostics Evidence Editorial Team. Last reviewed September 8, …
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 …