Here are three products named “Breakthrough Devices” by the FDA since May 1:
1. Optina Diagnostics’ retinal imaging platform uses AI to detect biomarkers of Alzheimer’s disease and other neurodegenerative diseases in eye scans.
2. The KidneyIntelX from Renalytix AI relies on machine learning algorithms to diagnose and manage fast-progressing kidney disease in Type 2 diabetes patients.
3. Grail’s methylation sequencing blood test uses DNA sequencing technology and machine learning algorithms to detect multiple forms of cancer and their tissues of origin.
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