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C2N Diagnostics Receives Breakthrough Device Designation from U.S. FDA for Blood Test to Screen for Alzheimer’s Disease Risk

1/29/19: This test will be used to screen for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis. To qualify for the FDA’s Breakthrough Device Program, a medical device must provide more effective diagnosis or treatment of a life-threatening or irreversibly debilitating condition, among other criteria. This program is designed to expedite the development and review of such medical devices.