FDA Watch: New Test for Esophageal Conditions is Coming to the US
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.
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FDA Watch: New BD Collection System Uses Just Tiny Amounts of Blood
Whether the MiniDraw™ device dredges up memories of Theranos’ failed tech remains to be seen.
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FDA Watch: Key Lab Test Clearances of 2023
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
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The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices
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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FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
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