MedTech News

KNoW Biological Receives FDA Breakthrough Device Designation

ATLANTA, May 13, 2025 /PRNewswire/ — KNoW Biological has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This designation is an FDA program designed to expedite the review of devices and medications for serious or life-threatening conditions where there’s preliminary evidence suggesting substantial improvement over existing therapies on the market.

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Low-cost blood test can measure proteins for early Alzheimer’s detection

Researchers from the Keck School of Medicine of USC have developed a blood test that can identify early signs of Alzheimer’s disease by measuring proteins linked to the condition. The new test, known as Penta-Plex Alzheimer’s Disease Capture Sandwich Immunoassay (5ADCSI), detects five biomarkers simultaneously, which is more than existing blood tests and runs on equipment commonly used in many laboratories.

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