FDA Watch - G2 Intelligence

FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection

The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan

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UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.

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Whether the MiniDraw™ device dredges up memories of Theranos’ failed tech remains to be seen.

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G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.

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The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.

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