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C2N Diagnostics Receives FDA 510(k) Clearance for Alzheimer's Blood Test

Published

20 August 2026

Topic

opportunities

◆ Sectors

Diagnostics

◆ Geography

United States

◆ Source

Read at 360dx.com →

◆ Verified

Fusion42 · 20 August 2026 · Fusion42 review

C2N Diagnostics has received FDA 510(k) clearance for its PrecivityAD2 blood test that detects Alzheimer's disease, enabling wider clinical adoption in the United States.

This Wire brief sits within Fusion42's coverage of Diagnostics, and 13 sources have reported it between 20 Aug 2026 and 26 Sep 2026.

◆ ◆ The Wire takeaway

You now have a clearer regulatory path to bring blood-based Alzheimer's diagnostics to US clinics. This opens opportunities to partner with health systems eager for earlier, easier testing.

◆ Coverage

13 sources · first reported 20 Aug 2026 · latest 26 Sep 2026

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◆ Topics

Diagnosticsfda-clearancealzheimersblood-testdiagnosticsregulatory-approval