FDA Withdraws Final Rule Regulating Lab-Developed Tests as Medical Devices
The action follows a federal court order that vacated the 2024 rule, reinstating FDA’s prior policy of enforcement discretion for laboratory-developed tests.
Read More
Search Results for: compliance
AdvaMed Calls for Diagnostic Tests to Be Included in Breakthrough Coverage Bill
AdvaMed urges inclusion of diagnostic tests in legislation that would provide four years of coverage for FDA-designated breakthrough technologies.
Read More
Lab CEO, Physicians, Marketers Pay $6M to Settle Kickback Allegations
Settlement resolves False Claims Act litigation alleging illegal payments disguised as management service organization distributions.
Read More
AI Assistant Integrated Into Lab Management Platform
The tool provides real-time support for experiment troubleshooting, protocol optimization, and data analysis within the existing workflow.
Read More
Laboratory Automation and Industrial Robotics Workflow Orchestration Platform Introduced
The vendor-neutral platform is designed to connect instruments, robotics, and enterprise systems to improve throughput and compliance.
Read More