Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
AI in Health Care: Balancing Benefits and Barriers
AI can help alleviate the burden on clinical labs—but only with sufficient investment, enthusiasm, and understanding
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
Computing the Future of the Lab
Computational biology expert Keaun Amani shares his advice and insights on AI and machine learning tools for the clinical lab
Dissecting the Data Behind Healthcare AI
How do the underlying datasets affect artificial intelligence tools’ performance in the lab—and beyond?
Labs in Court: Two EKRA-Related Cases and Some Usual Suspects
Recent enforcement actions involved usual targets such as COVID-19, genetic, and urine drug testing, but EKRA also made an appearance
Dx Deals: Labcorp Acquires Stake in European Testing Giant
$152.1 million SYNLAB deal is expected to create a new channel for Labcorp to market its sophisticated specialty assays
Has Your AI Been Validated?
Many artificial intelligence-based medical devices have not undergone clinical validation—but what does this mean for the lab?
How Do You Solve a Problem Like AI Regulation?
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
