Which medical device innovation was first approved by the FDA as a 'Breakthrough Device' that uses AI to detect diabetic retinopathy without requiring a specialist?

The medical industry constantly evolves through innovative product development. Groundbreaking devices that monitor vital signs, administer medication, or assist in surgeries can dramatically improve patient outcomes and transform healthcare delivery. This poll tests your knowledge about a recent revolutionary medical product development that changed standard treatment protocols. Do you keep up with the latest medical product innovations?

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IDx-DR (now known as Digital Diagnostics), which autonomously analyzes retinal images for diabetic retinopathy
AliveCor KardiaMobile, which detects atrial fibrillation through fingertip ECG readings
Medtronic Guardian Connect CGM, which predicts dangerous glucose levels 60 minutes before they occur
Apple Watch Series 4+, which performs electrocardiograms and detects falls in patients