Since the beginning of the month, the FDA has granted several artificial intelligence-powered health IT products "Breakthrough Device" status, which does not indicate safety approval, but designates a product as potentially life-saving and fast-tracks its development, testing and approval process.
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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