By the Connected Diagnostics Evidence Team Why Do Analytical Performance and Clinical Performance Matter? Analytical performance and clinical performance are two different measures of how well a …
How to Read a Medical Device Safety Alert or Recall for a Connected Diagnostic Tool
By the Connected Diagnostics Evidence Team A medical device safety alert or recall is an official notice, usually published by a regulator like the FDA, that a specific product has a confirmed or …
Bias and Representation in Connected Diagnostic Evidence: Questions to Ask of a Study
By the Connected Diagnostics Evidence Team A diagnostic-device study can be well-designed and still not tell you what you think it tells you. That happens when the people, settings, or data in the …
Cybersecurity Questions for Connected Diagnostic Devices and Medical Image Systems
By the Connected Diagnostics Evidence Team Cybersecurity Questions to Ask Before Connecting a Diagnostic Device Connecting a home health imaging device or diagnostic tool to your Wi-Fi and creating …
Human Factors in Connected Diagnostic Devices: Why Usability Is a Safety Question
By the Connected Diagnostics Evidence Team Human factors are the reason a connected diagnostic device can be accurate in a lab and still fail in your home. Before trusting a result, ask whether the …
Positive Predictive Value: How Prevalence Changes Results
By the Connected Diagnostics Evidence Team What Does a Positive Predictive Value Actually Tell You? Positive predictive value (PPV) is the probability that a positive result — including one from a …
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