Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
FDA-dtet
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 Imposes New Limits on COVID-19 Tests with Access to EUA Pathway
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Management Expert Report Cites Weaknesses in Agency’s EUA Processes
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
False Positive Recalls Casts Doubt on Rapid COVID Screening Tests at the Worst Possible Time
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Requires EUA SARS-CoV-2 Test Developers to Account for Viral Mutations
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Regulation of COVID-19 Testing Enters a New Phase
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Newly Reintroduced VITAL Act Would Strip Agency of LDT Regulatory Authority
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Agency Streamlines Authorization of COVID-19 Molecular Test Pooling for Screening Programs
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here