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C2N Diagnostics Receives FDA 510(k) Clearance for Alzheimer's Blood Test
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Diagnostics
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United States
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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 3 sources have reported it.
◆ ◆ 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
3 sources · 20 Aug 2026
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Diagnosticsfda-clearancealzheimersblood-testdiagnosticsregulatory-approval