FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
Industry Buzz-lir
Subscribe today for access to
Articles and Reports
An Automated Assist in Revenue Cycle Management
How automation, artificial intelligence, and other emerging technologies are elevating the efficiency and output of labs’ revenue cycles
Digital Pathology and AI: Now and in 2025
Experts Nathan Buchbinder and Julianna Ianni discuss digital pathology and AI trends in 2024—and what the next year may hold
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
Already a member? Log in here
Communication: Managing Amid Change
From - Laboratory Industry Report
Greek philosopher Heraclitus said the only thing constant is change. Although he never managed a diagnostic laboratory, his words…
FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results
From - Laboratory Industry Report
On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to…
Investment Trends: Dx/Tools Venture Capital Keeps Flowing Despite Decline in Early-Stage Investment
From - Laboratory Industry Report
Continuing a four-year trend, total U.S. venture capital investment in health care surged in 2018, reaching a new all-time high of…
FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review
From - Laboratory Industry Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
Earnings Report: Top Payers Announce Q3 Earnings
From - Laboratory Industry Report
The country's five largest commercial payers posted strong results for the third quarter of fiscal year 2018…
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
From - Laboratory Industry Report
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for…
6 Steps to Data-Driven Transformation
By Nir Kaldero bio
We're now well into the Fourth Industrial Revolution. The First Industrial Revolution was about steam and railroads, the Second about electricity, and the…
FDA Watch: Changes to CBER Email Policy May Affect Your Lab
From - Laboratory Industry Report
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use…
