By the Connected Diagnostics Evidence Team When a connected diagnostic device study reports how well it works, some images or readings almost always come back unclear, blurry, or impossible to …
Diagnostic Cutoffs in Connected Devices: Why a Threshold Changes the Result
By the Connected Diagnostics Evidence Team The Number Behind the Result When a connected diagnostic device — a phone-linked otoscope, a home ECG patch, a digital rapid-test reader — tells you …
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Postmarket Surveillance for Medical Devices: What It Is Designed to Learn
By the Connected Diagnostics Evidence Team A Device Gets Cleared. What Does Postmarket Surveillance Do Next? Postmarket surveillance is the FDA's ongoing monitoring of a medical device after it's …
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Medical Device Interoperability: Questions to Ask
By the Connected Diagnostics Evidence Team What Does Medical Device Interoperability Mean? Medical device interoperability is the ability of a connected medical device to safely, securely, and …
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Medical Image Storage and Communication: What a Connected Diagnostics Workflow Needs to Explain
By the Connected Diagnostics Evidence Team What Medical Image Storage and Communication Means in a Connected Workflow Medical image storage and communication describes how a health image moves …
Clinical Decision Support or Diagnostic Device Software? How FDA Describes the Difference
By the Connected Diagnostics Evidence Team Clinical decision support vs. diagnostic device software: what’s the actual difference? Clinical decision support (CDS) software gives a health care …