Quality, Standards & Compliance
|3 min read
FDA Releases New Principles for Machine Learning-Enabled Medical Devices
The new guiding principles promote transparency to build trust and improve the user experience of machine learning-enabled medical devices
|2 min read
Top 3 Tips: Implementing Robust Quality Control Protocols to Prevent Errors
Three tips for implementing robust quality control protocols and procedures to prevent errors and ensure patient well-being
|2 min read
ACLA Sues the FDA Over Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
‘FDA’s final rule is the wrong approach’ for LDTs, ACLA president says
|2 min read
Trio of Lawmakers Introduces Resolution to Repeal FDA Final Rule on LDTs
Reps. Finstad and Crenshaw, Sen. Paul introduce a resolution under the Congressional Review Act to repeal harmful FDA rule limiting access to laboratory-developed tests
|2 min read
The FDA's Final LDTs Rule Is Out—Now What?
The Mayo Clinic’s Shannon Bennett shares his initial thoughts on the rule and what clinical labs will need to do
|3 min read
ADLM President: 'LDTs Should Remain under CLIA'
Octavia Peck Palmer reacts to the FDA’s new final rule on lab-developed tests
|1 min read
Biofortuna Acquires Biological Sample Storage Company Cryoniss
Deal centers on temperature-controlled services
Updated |3 min read
Applying AI to Handwriting May Offset Critical Lab Staffing Shortages
Accuracy of handwriting recognition technology has improved
Updated |3 min read
Lab of the Future: Shifting to a Data-Centric Approach
Among the changes could be the creation of a patient’s ‘digital twin’
Available on Demand
What You Need to Know about the FDA's New LDT Regulations
Join us on May 30 to discuss what steps clinical lab leaders will need to take to ensure they are prepared for the FDA's new LDTs rule
Updated |2 min read
ADLM Opposes FDA Ruling on Laboratory-Developed Tests
ADLM president urging the FDA to involve all stakeholders in modernizing LDT regulation to improve patient care
|5 min read
