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 …
Mobile Clinical Microscopy in the Field: Laboratory Performance Versus Real-World Implementation
By the Connected Diagnostics Evidence Team Mobile Clinical Microscopy: Why Lab Results and Field Results Differ Mobile clinical microscopy devices can perform well in a controlled study and still …
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 …
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 …