Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
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Has Your AI Been Validated?
Many artificial intelligence-based medical devices have not undergone clinical validation—but what does this mean for the lab?
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
FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
InspectIR Nabs First FDA Approval for a SARS-CoV-2 Breathalyzer
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
One Year Is Not Enough to Harmonize Quality Systems with ISO 13485
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2021 Was a Breakthrough Year for Breakthrough Devices Program
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
Scorecard: COVID-19 Rapid Test Recalls and Warnings in 2022
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Agency Continues Crack Down on Unauthorized COVID-19 Tests
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.
FDA Points the Way to Transition EUA SARS-CoV-2 Tests to Full Approval
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Device Reclassification Order Opens 510(k) Pathway for HCV RNA and Antibodies Tests
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Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)
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