FDA Watch: FDA Moves Slowly on AI-Driven Lab Devices
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
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Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible
Expansion of use for two assays gives patients the option to self-collect specimens at home and in the clinic, which may help address gaps in screening
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FDA Watch: Could Guardant Health’s Colon Cancer Assay Be a Blockbuster?
The company is hiring at least 100 sales representatives this year to spread awareness and uptake of its recently FDA-approved Shield test
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Diagnostics Pipeline: Scientists Ask Agency to Rescind Approval for Opioid Management Test
Experts—including those in genetics and device regulation—say the AvertD assay did not predict risks of abuse ‘any better than chance’
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Loper Bright Renews Interest in the VALID Act
The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation
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